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nasdaq:ctmx cytomx.com cytomx.com Jun 20th, 2019 12:00AM Sr. Associate/Manager, Regulatory Affairs Operations Open Regulatory Affairs and Quality Assurance South San Francisco, CA, United States South San Francisco CA USA Mar 27th, 2019 12:00AM Sr. Associate/Manager – Regulatory Affairs, Operations About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: This position reports to the Director of Regulatory Affairs.The Opportunity:The Sr. Associate/Manager – Regulatory Affairs, Operations is a hands-on position with direct responsibilities for the formatting, compilation, and publishing activities associated with routine and complex submissions to health authorities. Responsibilities also include direct involvement in the associated document management activities and oversight of the submission archives. The individual in this position will play a critical role maintaining CytomX’s high standard for submissions to health authorities.Professional Responsibilities:In conjunction with Regulatory Affairs, coordinate the planning, preparation, and submission of regulatory documents, including generation of submission preparation trackers and follow-up with authors/reviewers to maintain timelines.Preform and/or oversee the formatting, compilation, and publishing of a variety of regulatory applications compliant to electronic submission standards using standard publishing software.Manage the regulatory submission archives in accordance with departmental requirements.Participation in the company’s initiative to implement an electronic document management and archival system.Develop and implement regulatory documentation format and style criteria.Oversee the creation and implementation of document templates, including providing training sessions for appropriate individuals and providing ongoing technical support.Interface with regulatory department staff and/or content authors to ensure proper publishing of regulatory applications, including adherence to timelines.Maintain the global regulatory filing and tracking system.Resolve problems and provide guidance to individuals involved with generating document for regulatory application.Provide and keep current SOPs pertaining to the job functions. Education/Experience:4+ years of regulatory affairs operations/publishing experience or equivalent trainingMinimum of a bachelor’s degree or equivalent experience. Professional Requirements:Demonstrated ability to ensure efficient electronic submission of regulatory applications in accordance with publishing requirements.Strong working knowledge of regulations and guidelines governing electronic submissions.Prior electronic submission experience working with a variety of regulatory applications in US and Europe.A consistent demonstration of attention to detail, timeliness, and accuracy is critical.Highly proficient in using Microsoft Word, Excel, and Acrobat Adobe (PDF), as well knowledgeable with eCTD publishing software. Personal Characteristics:Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and FunAbility to work with minimal supervision, identify compliance risks, and resolve issues within assigned scope or work.Energetic, resourceful self-starter with high integrity.Intellectually curious, enthusiastic, and creative.Excellent communication skills.Team-player comfortable in fast-moving, dynamic environments. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 20th, 2019 04:08AM Jun 20th, 2019 04:08AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 21st, 2019 12:00AM Sr. Manager, Regulatory Affairs Development Open Regulatory Affairs and Quality Assurance South San Francisco, CA, United States South San Francisco CA USA Mar 11th, 2019 12:00AM Sr. Manager – Regulatory Affairs, Development About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: This position reports to a Director or Senior Director of Regulatory Affairs.The Opportunity:The Sr. Manager – Regulatory Affairs, Development is a hands-on position responsible to manage the compilation of world-wide applications to health authorities that are required to support CytomX’s pipeline products through all stages of development from preclinical through clinical to registration, including partnering with department staff and project team members. This position also includes assisting in managing direct interactions with health authorities and for contributing to strategic development decision making on complex issues and resolution of issues encountered during development. The primary responsibility will focus on the activities relating to clinical and nonclinical development. This position will play a critical role in maintaining CytomX’s high standard for submissions to and interactions with health authorities.Professional Responsibilities:Under minimal managerial direction, manage the development and submission of world-wide regulatory applications (eg, IND, CTA, BLA, MAA, and associated amendments) and for ensuring applications consistently meet CytomX’s high standard and team timelines for submissions to health authorities.Represent the regulatory development function on assigned projects (eg, study teams, working groups)In partnership with regulatory management, work to direct regulatory development strategy on complex issues, proactively identify possible development problems and identify possible mitigation strategies, and effectively resolve issues when they occur.Assist in establishing, implementing, and managing submission/regulatory information trackers for assigned programs.Assist in coordination of regulatory agency meetings and preparation of meeting materials.Manage CRO activities where regulatory activities have been outsourced.Maintain awareness of changes in the regulatory space and distribute newly issued regulations/guidance within CytomX. Education/Experience:BA/BS or equivalent education and 7+ years Regulatory Affairs experience or equivalent training/experience. [BA/BS and 8 years, MS and 6 years, PhD/PharmD/MD and 4 years Regulatory Affairs (FDA) / drug development experience or equivalent training]Oncology drug development a plus. Professional Requirements:Hands-on experience with a variety of complex regulatory submissions to FDA and EU competent authorities, including components, organizational structure, and processes.Demonstrated understanding of US and EU regulations and guidelines governing drug development (particularly clinical drug development) including ability to apply these to overall strategic drug development.Good background in general biological/physical science and the ability to apply that knowledge to challenging and complex R&D regulatory issues.Strong analytical ability in evaluating and interpreting scientific data used to support regulatory submissions.Excellent writing and organizational skills, and an ability to generate clear, concise documents.PC computer skills required; ie, proficient with MS Office software, Adobe Acrobat.Experience having worked in a controlled document environment, collaborative workflow for document reviews, expertise with templates and formatting tools.Experience having been part of R&D teams.Ability to influence others, with or without authority. Personal Characteristics:Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and FunExcellent communication skills with an ability to communicate in a clear, concise manner.Excellent interpersonal skills, collaborative approach essential.Self-motivated with a strong sense of ownership in areas of responsibility.Diligent, detail oriented.Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.Personal commitment to delivering quality work on time.Responsive, resilient, flexible.Energetic, resourceful self-starter with high integrity.Intellectually curious, enthusiastic, and creative.Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 21st, 2019 04:05AM Jun 21st, 2019 04:05AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 21st, 2019 12:00AM Sr. Associate/Manager, Regulatory Affairs Operations Open Regulatory Affairs and Quality Assurance South San Francisco, CA, United States South San Francisco CA USA Mar 27th, 2019 12:00AM Sr. Associate/Manager – Regulatory Affairs, Operations About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: This position reports to the Director of Regulatory Affairs.The Opportunity:The Sr. Associate/Manager – Regulatory Affairs, Operations is a hands-on position with direct responsibilities for the formatting, compilation, and publishing activities associated with routine and complex submissions to health authorities. Responsibilities also include direct involvement in the associated document management activities and oversight of the submission archives. The individual in this position will play a critical role maintaining CytomX’s high standard for submissions to health authorities.Professional Responsibilities:In conjunction with Regulatory Affairs, coordinate the planning, preparation, and submission of regulatory documents, including generation of submission preparation trackers and follow-up with authors/reviewers to maintain timelines.Preform and/or oversee the formatting, compilation, and publishing of a variety of regulatory applications compliant to electronic submission standards using standard publishing software.Manage the regulatory submission archives in accordance with departmental requirements.Participation in the company’s initiative to implement an electronic document management and archival system.Develop and implement regulatory documentation format and style criteria.Oversee the creation and implementation of document templates, including providing training sessions for appropriate individuals and providing ongoing technical support.Interface with regulatory department staff and/or content authors to ensure proper publishing of regulatory applications, including adherence to timelines.Maintain the global regulatory filing and tracking system.Resolve problems and provide guidance to individuals involved with generating document for regulatory application.Provide and keep current SOPs pertaining to the job functions. Education/Experience:4+ years of regulatory affairs operations/publishing experience or equivalent trainingMinimum of a bachelor’s degree or equivalent experience. Professional Requirements:Demonstrated ability to ensure efficient electronic submission of regulatory applications in accordance with publishing requirements.Strong working knowledge of regulations and guidelines governing electronic submissions.Prior electronic submission experience working with a variety of regulatory applications in US and Europe.A consistent demonstration of attention to detail, timeliness, and accuracy is critical.Highly proficient in using Microsoft Word, Excel, and Acrobat Adobe (PDF), as well knowledgeable with eCTD publishing software. Personal Characteristics:Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and FunAbility to work with minimal supervision, identify compliance risks, and resolve issues within assigned scope or work.Energetic, resourceful self-starter with high integrity.Intellectually curious, enthusiastic, and creative.Excellent communication skills.Team-player comfortable in fast-moving, dynamic environments. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 21st, 2019 04:05AM Jun 21st, 2019 04:05AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 17th, 2019 12:00AM Scientist 1, Protein Sciences Open Protein Sciences Jun 13th, 2019 12:00AM Scientist I, Protein Sciences About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: Reports to Senior Director, Protein SciencesThe Opportunity:We seek a highly motivated individual to support the protein purification and analytical method development needs for all the discovery programs at CytomX. The successful candidate will work as a Scientist I in the Protein Sciences Department and contribute to the lead selection process by implementation of parallel purification and developability assessment of Probodies and Bispecifics.Professional Responsibilities:Develop parallel purification processes for antibodies, Probodies and Bispecifics. Support the protein purification workflow to meet the needs from Protein Engineering, Process Sciences and biology groups.Develop purification strategies for various bispecific formatsSolve protein purification problems based on scientific principles, current technologies, and personal experienceDevelop analytical methods to characterize Probodies, Probody drug conjugates and bispecifics to support Discovery programsSupport developability assessment of Probodies, Probody Drug Conjugates and bispecificsOrganize data and communicate results in internal and external scientific meetings Education/Experience:Ph.D. in Biochemistry or Protein Chemistry or related discipline with 3 + years of experience in the biotechnology or biopharma industry or MS in Biochemistry with 10+ years of experience in the biotechnology or biopharma industry. Professional Requirements:Expertise in large and small-scale protein purification using multi-channel pumps, AKTA systems, Tecan or Janus liquid handler system is required.Should be well versed in protein characterization assays such as concentration, endotoxin measurement, SDS-PAGE, CE-SDS, SEC-HPLC, RP-HPLC, IEF, Glycan analysis and HICExperience in developing ELISA based potency assays is requiredFamiliarity with polyclonal and monoclonal anti-Id generation process is desiredHands on experience in operating Agilent/Waters/Thermo HPLC or UPLC instruments, Protein Simple Maurice iCIEF and CE-SDS and Unchained Labs Uncle systems is desiredExperience in developing analytical methods to characterize antibodies and antibody drug conjugates is required.Expertise in developability assessment of therapeutic biologics molecules is desiredHands on experience in operating the mass spec instruments is desiredExperience in managing the protein purification workflow is required. Personal Characteristics: Energetic, resourceful self-starter with high integrityTeam-player comfortable in fast-moving, dynamic environmentsIntellectually curious, enthusiastic, creativeAdaptable and resilient with a problem-solving orientationInnovative and flexibleDemonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and Fun. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 17th, 2019 10:49AM Jun 17th, 2019 10:49AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 18th, 2019 12:00AM Scientist 1, Protein Sciences Open Protein Sciences Jun 13th, 2019 12:00AM Scientist I, Protein Sciences About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: Reports to Senior Director, Protein SciencesThe Opportunity:We seek a highly motivated individual to support the protein purification and analytical method development needs for all the discovery programs at CytomX. The successful candidate will work as a Scientist I in the Protein Sciences Department and contribute to the lead selection process by implementation of parallel purification and developability assessment of Probodies and Bispecifics.Professional Responsibilities:Develop parallel purification processes for antibodies, Probodies and Bispecifics. Support the protein purification workflow to meet the needs from Protein Engineering, Process Sciences and biology groups.Develop purification strategies for various bispecific formatsSolve protein purification problems based on scientific principles, current technologies, and personal experienceDevelop analytical methods to characterize Probodies, Probody drug conjugates and bispecifics to support Discovery programsSupport developability assessment of Probodies, Probody Drug Conjugates and bispecificsOrganize data and communicate results in internal and external scientific meetings Education/Experience:Ph.D. in Biochemistry or Protein Chemistry or related discipline with 3 + years of experience in the biotechnology or biopharma industry or MS in Biochemistry with 10+ years of experience in the biotechnology or biopharma industry. Professional Requirements:Expertise in large and small-scale protein purification using multi-channel pumps, AKTA systems, Tecan or Janus liquid handler system is required.Should be well versed in protein characterization assays such as concentration, endotoxin measurement, SDS-PAGE, CE-SDS, SEC-HPLC, RP-HPLC, IEF, Glycan analysis and HICExperience in developing ELISA based potency assays is requiredFamiliarity with polyclonal and monoclonal anti-Id generation process is desiredHands on experience in operating Agilent/Waters/Thermo HPLC or UPLC instruments, Protein Simple Maurice iCIEF and CE-SDS and Unchained Labs Uncle systems is desiredExperience in developing analytical methods to characterize antibodies and antibody drug conjugates is required.Expertise in developability assessment of therapeutic biologics molecules is desiredHands on experience in operating the mass spec instruments is desiredExperience in managing the protein purification workflow is required. Personal Characteristics: Energetic, resourceful self-starter with high integrityTeam-player comfortable in fast-moving, dynamic environmentsIntellectually curious, enthusiastic, creativeAdaptable and resilient with a problem-solving orientationInnovative and flexibleDemonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and Fun. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 18th, 2019 04:00AM Jun 18th, 2019 04:00AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 19th, 2019 12:00AM Scientist 1, Protein Sciences Open Protein Sciences Jun 13th, 2019 12:00AM Scientist I, Protein Sciences About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: Reports to Senior Director, Protein SciencesThe Opportunity:We seek a highly motivated individual to support the protein purification and analytical method development needs for all the discovery programs at CytomX. The successful candidate will work as a Scientist I in the Protein Sciences Department and contribute to the lead selection process by implementation of parallel purification and developability assessment of Probodies and Bispecifics.Professional Responsibilities:Develop parallel purification processes for antibodies, Probodies and Bispecifics. Support the protein purification workflow to meet the needs from Protein Engineering, Process Sciences and biology groups.Develop purification strategies for various bispecific formatsSolve protein purification problems based on scientific principles, current technologies, and personal experienceDevelop analytical methods to characterize Probodies, Probody drug conjugates and bispecifics to support Discovery programsSupport developability assessment of Probodies, Probody Drug Conjugates and bispecificsOrganize data and communicate results in internal and external scientific meetings Education/Experience:Ph.D. in Biochemistry or Protein Chemistry or related discipline with 3 + years of experience in the biotechnology or biopharma industry or MS in Biochemistry with 10+ years of experience in the biotechnology or biopharma industry. Professional Requirements:Expertise in large and small-scale protein purification using multi-channel pumps, AKTA systems, Tecan or Janus liquid handler system is required.Should be well versed in protein characterization assays such as concentration, endotoxin measurement, SDS-PAGE, CE-SDS, SEC-HPLC, RP-HPLC, IEF, Glycan analysis and HICExperience in developing ELISA based potency assays is requiredFamiliarity with polyclonal and monoclonal anti-Id generation process is desiredHands on experience in operating Agilent/Waters/Thermo HPLC or UPLC instruments, Protein Simple Maurice iCIEF and CE-SDS and Unchained Labs Uncle systems is desiredExperience in developing analytical methods to characterize antibodies and antibody drug conjugates is required.Expertise in developability assessment of therapeutic biologics molecules is desiredHands on experience in operating the mass spec instruments is desiredExperience in managing the protein purification workflow is required. Personal Characteristics: Energetic, resourceful self-starter with high integrityTeam-player comfortable in fast-moving, dynamic environmentsIntellectually curious, enthusiastic, creativeAdaptable and resilient with a problem-solving orientationInnovative and flexibleDemonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and Fun. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 19th, 2019 04:50AM Jun 19th, 2019 04:50AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 20th, 2019 12:00AM Scientist 1, Protein Sciences Open Protein Sciences Jun 13th, 2019 12:00AM Scientist I, Protein Sciences About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: Reports to Senior Director, Protein SciencesThe Opportunity:We seek a highly motivated individual to support the protein purification and analytical method development needs for all the discovery programs at CytomX. The successful candidate will work as a Scientist I in the Protein Sciences Department and contribute to the lead selection process by implementation of parallel purification and developability assessment of Probodies and Bispecifics.Professional Responsibilities:Develop parallel purification processes for antibodies, Probodies and Bispecifics. Support the protein purification workflow to meet the needs from Protein Engineering, Process Sciences and biology groups.Develop purification strategies for various bispecific formatsSolve protein purification problems based on scientific principles, current technologies, and personal experienceDevelop analytical methods to characterize Probodies, Probody drug conjugates and bispecifics to support Discovery programsSupport developability assessment of Probodies, Probody Drug Conjugates and bispecificsOrganize data and communicate results in internal and external scientific meetings Education/Experience:Ph.D. in Biochemistry or Protein Chemistry or related discipline with 3 + years of experience in the biotechnology or biopharma industry or MS in Biochemistry with 10+ years of experience in the biotechnology or biopharma industry. Professional Requirements:Expertise in large and small-scale protein purification using multi-channel pumps, AKTA systems, Tecan or Janus liquid handler system is required.Should be well versed in protein characterization assays such as concentration, endotoxin measurement, SDS-PAGE, CE-SDS, SEC-HPLC, RP-HPLC, IEF, Glycan analysis and HICExperience in developing ELISA based potency assays is requiredFamiliarity with polyclonal and monoclonal anti-Id generation process is desiredHands on experience in operating Agilent/Waters/Thermo HPLC or UPLC instruments, Protein Simple Maurice iCIEF and CE-SDS and Unchained Labs Uncle systems is desiredExperience in developing analytical methods to characterize antibodies and antibody drug conjugates is required.Expertise in developability assessment of therapeutic biologics molecules is desiredHands on experience in operating the mass spec instruments is desiredExperience in managing the protein purification workflow is required. Personal Characteristics: Energetic, resourceful self-starter with high integrityTeam-player comfortable in fast-moving, dynamic environmentsIntellectually curious, enthusiastic, creativeAdaptable and resilient with a problem-solving orientationInnovative and flexibleDemonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and Fun. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 20th, 2019 04:08AM Jun 20th, 2019 04:08AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 21st, 2019 12:00AM Scientist 1, Protein Sciences Open Protein Sciences Jun 13th, 2019 12:00AM Scientist I, Protein Sciences About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: Reports to Senior Director, Protein SciencesThe Opportunity:We seek a highly motivated individual to support the protein purification and analytical method development needs for all the discovery programs at CytomX. The successful candidate will work as a Scientist I in the Protein Sciences Department and contribute to the lead selection process by implementation of parallel purification and developability assessment of Probodies and Bispecifics.Professional Responsibilities:Develop parallel purification processes for antibodies, Probodies and Bispecifics. Support the protein purification workflow to meet the needs from Protein Engineering, Process Sciences and biology groups.Develop purification strategies for various bispecific formatsSolve protein purification problems based on scientific principles, current technologies, and personal experienceDevelop analytical methods to characterize Probodies, Probody drug conjugates and bispecifics to support Discovery programsSupport developability assessment of Probodies, Probody Drug Conjugates and bispecificsOrganize data and communicate results in internal and external scientific meetings Education/Experience:Ph.D. in Biochemistry or Protein Chemistry or related discipline with 3 + years of experience in the biotechnology or biopharma industry or MS in Biochemistry with 10+ years of experience in the biotechnology or biopharma industry. Professional Requirements:Expertise in large and small-scale protein purification using multi-channel pumps, AKTA systems, Tecan or Janus liquid handler system is required.Should be well versed in protein characterization assays such as concentration, endotoxin measurement, SDS-PAGE, CE-SDS, SEC-HPLC, RP-HPLC, IEF, Glycan analysis and HICExperience in developing ELISA based potency assays is requiredFamiliarity with polyclonal and monoclonal anti-Id generation process is desiredHands on experience in operating Agilent/Waters/Thermo HPLC or UPLC instruments, Protein Simple Maurice iCIEF and CE-SDS and Unchained Labs Uncle systems is desiredExperience in developing analytical methods to characterize antibodies and antibody drug conjugates is required.Expertise in developability assessment of therapeutic biologics molecules is desiredHands on experience in operating the mass spec instruments is desiredExperience in managing the protein purification workflow is required. Personal Characteristics: Energetic, resourceful self-starter with high integrityTeam-player comfortable in fast-moving, dynamic environmentsIntellectually curious, enthusiastic, creativeAdaptable and resilient with a problem-solving orientationInnovative and flexibleDemonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and Fun. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 21st, 2019 04:05AM Jun 21st, 2019 04:05AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 24th, 2019 12:00AM Sr. Manager, Regulatory Affairs Development Open Regulatory Affairs and Quality Assurance South San Francisco, CA, United States South San Francisco CA USA Mar 11th, 2019 12:00AM Sr. Manager – Regulatory Affairs, Development About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: This position reports to a Director or Senior Director of Regulatory Affairs.The Opportunity:The Sr. Manager – Regulatory Affairs, Development is a hands-on position responsible to manage the compilation of world-wide applications to health authorities that are required to support CytomX’s pipeline products through all stages of development from preclinical through clinical to registration, including partnering with department staff and project team members. This position also includes assisting in managing direct interactions with health authorities and for contributing to strategic development decision making on complex issues and resolution of issues encountered during development. The primary responsibility will focus on the activities relating to clinical and nonclinical development. This position will play a critical role in maintaining CytomX’s high standard for submissions to and interactions with health authorities.Professional Responsibilities:Under minimal managerial direction, manage the development and submission of world-wide regulatory applications (eg, IND, CTA, BLA, MAA, and associated amendments) and for ensuring applications consistently meet CytomX’s high standard and team timelines for submissions to health authorities.Represent the regulatory development function on assigned projects (eg, study teams, working groups)In partnership with regulatory management, work to direct regulatory development strategy on complex issues, proactively identify possible development problems and identify possible mitigation strategies, and effectively resolve issues when they occur.Assist in establishing, implementing, and managing submission/regulatory information trackers for assigned programs.Assist in coordination of regulatory agency meetings and preparation of meeting materials.Manage CRO activities where regulatory activities have been outsourced.Maintain awareness of changes in the regulatory space and distribute newly issued regulations/guidance within CytomX. Education/Experience:BA/BS or equivalent education and 7+ years Regulatory Affairs experience or equivalent training/experience. [BA/BS and 8 years, MS and 6 years, PhD/PharmD/MD and 4 years Regulatory Affairs (FDA) / drug development experience or equivalent training]Oncology drug development a plus. Professional Requirements:Hands-on experience with a variety of complex regulatory submissions to FDA and EU competent authorities, including components, organizational structure, and processes.Demonstrated understanding of US and EU regulations and guidelines governing drug development (particularly clinical drug development) including ability to apply these to overall strategic drug development.Good background in general biological/physical science and the ability to apply that knowledge to challenging and complex R&D regulatory issues.Strong analytical ability in evaluating and interpreting scientific data used to support regulatory submissions.Excellent writing and organizational skills, and an ability to generate clear, concise documents.PC computer skills required; ie, proficient with MS Office software, Adobe Acrobat.Experience having worked in a controlled document environment, collaborative workflow for document reviews, expertise with templates and formatting tools.Experience having been part of R&D teams.Ability to influence others, with or without authority. Personal Characteristics:Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and FunExcellent communication skills with an ability to communicate in a clear, concise manner.Excellent interpersonal skills, collaborative approach essential.Self-motivated with a strong sense of ownership in areas of responsibility.Diligent, detail oriented.Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.Personal commitment to delivering quality work on time.Responsive, resilient, flexible.Energetic, resourceful self-starter with high integrity.Intellectually curious, enthusiastic, and creative.Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 24th, 2019 04:06AM Jun 24th, 2019 04:06AM Health Care Pharmaceuticals & Biotechnology
nasdaq:ctmx cytomx.com cytomx.com Jun 24th, 2019 12:00AM Sr. Associate/Manager, Regulatory Affairs Operations Open Regulatory Affairs and Quality Assurance South San Francisco, CA, United States South San Francisco CA USA Mar 27th, 2019 12:00AM Sr. Associate/Manager – Regulatory Affairs, Operations About CytomX Therapeutics:CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.comLocation: South San Francisco, CaliforniaReporting Relationship: This position reports to the Director of Regulatory Affairs.The Opportunity:The Sr. Associate/Manager – Regulatory Affairs, Operations is a hands-on position with direct responsibilities for the formatting, compilation, and publishing activities associated with routine and complex submissions to health authorities. Responsibilities also include direct involvement in the associated document management activities and oversight of the submission archives. The individual in this position will play a critical role maintaining CytomX’s high standard for submissions to health authorities.Professional Responsibilities:In conjunction with Regulatory Affairs, coordinate the planning, preparation, and submission of regulatory documents, including generation of submission preparation trackers and follow-up with authors/reviewers to maintain timelines.Preform and/or oversee the formatting, compilation, and publishing of a variety of regulatory applications compliant to electronic submission standards using standard publishing software.Manage the regulatory submission archives in accordance with departmental requirements.Participation in the company’s initiative to implement an electronic document management and archival system.Develop and implement regulatory documentation format and style criteria.Oversee the creation and implementation of document templates, including providing training sessions for appropriate individuals and providing ongoing technical support.Interface with regulatory department staff and/or content authors to ensure proper publishing of regulatory applications, including adherence to timelines.Maintain the global regulatory filing and tracking system.Resolve problems and provide guidance to individuals involved with generating document for regulatory application.Provide and keep current SOPs pertaining to the job functions. Education/Experience:4+ years of regulatory affairs operations/publishing experience or equivalent trainingMinimum of a bachelor’s degree or equivalent experience. Professional Requirements:Demonstrated ability to ensure efficient electronic submission of regulatory applications in accordance with publishing requirements.Strong working knowledge of regulations and guidelines governing electronic submissions.Prior electronic submission experience working with a variety of regulatory applications in US and Europe.A consistent demonstration of attention to detail, timeliness, and accuracy is critical.Highly proficient in using Microsoft Word, Excel, and Acrobat Adobe (PDF), as well knowledgeable with eCTD publishing software. Personal Characteristics:Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and FunAbility to work with minimal supervision, identify compliance risks, and resolve issues within assigned scope or work.Energetic, resourceful self-starter with high integrity.Intellectually curious, enthusiastic, and creative.Excellent communication skills.Team-player comfortable in fast-moving, dynamic environments. CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Jun 24th, 2019 04:06AM Jun 24th, 2019 04:06AM Health Care Pharmaceuticals & Biotechnology

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