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Coherus BioSciences

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# Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
1 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Biochemistry Scientist (Temp-to-Hire) Open Analytical & Pharmaceutical Sciences Camarillo, CA, United States Camarillo CA USA Apr 4th, 2019 12:00AM <p><strong><u>Overview:</u></strong></p> <p>This temp-to-hire position works as part of the team to develop and perform analytical methods in protein and glycan biochemistry with an emphasis on current techniques in Mass Spectrometry.</p> <p><strong><u>Principle Responsibilities and Duties:</u></strong></p> <ul> <li>LC-MS/MS operation, maintenance and data interpretation. Techniques including peptide/glycopeptide/glycan/disulfide bond mapping, intact mass, PTM characterization and quantitative techniques.</li> <li>In supporting Process Development and Stability Programs, assist supervisor to investigate, create, develop, and qualify new methods or technologies for project advancement. </li> <li>Should be proficient in other biological, biochemical and biophysical characterization techniques.</li> <li>Contribute to collaborative projects with innovative research.  Maintain laboratory notebooks; write technical reports, summaries, protocols and quantitative analyses. </li> </ul> <p><strong><u>Experience, Education, Training, Traits: </u></strong></p> <ul> <li>Background knowledge and practical experience in developing bioanalytical methods for protein therapeutics, along with a proven track record of productivity, problems solving skills are essential.</li> <li>A background (2+ years) in Mass Spectrometry theory, operation and data analysis.</li> <li>Familiarity with standard word, excel, graphic, and presentation software is required, and familiarity with database/data archival software systems and computer programing is helpful.</li> <li>Excellent communication, interpersonal and organizational skills are required.</li> <li>Requires familiarity with current scientific literature together with capability to select methods and techniques for obtaining solutions within broadly defined practices and procedures.</li> </ul> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
2 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Executive Director, Commercial Transactions Open Legal Redwood City, CA, United States Redwood City CA USA Mar 12th, 2019 12:00AM <p><strong>Overview: </strong></p> <p>Reporting to the Senior Vice President, Transactions &amp; Legal Affairs, the Executive Director, Commercial Transactions will be responsible for commercial transactions for Coherus BioSciences’ commercial function.</p> <p><strong>Principal Responsibilities and Duties: </strong></p> <ul> <li>Draft, review and negotiate all commercial contracts including domestic and international sales, customer, vendor and payer contracts, including GPO purchasing agreements, distribution services agreements and payer rebate agreements, statements of work, RFP responses and supporting documents across the Commercial function.</li> <li>Review and revise third party contract templates.</li> <li>Provide rapid, practical, business-oriented legal/commercial contract advice directly to business clients.</li> <li>Support business clients in negotiating price, deliverables, scope of services, representations and warranties, indemnification and other commercial terms.</li> <li>Apply innovative problem-solving skills and practical business judgment to maximize revenues, minimize risk and foster long-term customer relationships.</li> <li>Collaborate with and facilitate cross-team decision-making among the Legal team, Commercial team, Finance team, and other internal teams.</li> <li>Manage assigned projects to completion.</li> <li>Assist more senior attorneys and management in higher-level matters, as needed.</li> <li>All other duties as assigned.</li> </ul> <p><strong>Qualifications</strong></p> <ul> <li>J.D. degree from an accredited law school required.</li> <li>Licensed to practice law in a US state or DC.</li> <li>10-15 years of relevant experience in a law firm and/or corporate legal department; in-house corporate legal department experience preferred.</li> <li>Pharmaceutical or Healthcare Industry experience required.</li> <li>Experience negotiating commercial contracts and other experience demonstrating ability to handle and close commercial and legal negotiations.</li> <li>Healthcare compliance counseling experience preferred.</li> <li>Experience working in a fast-paced, fluid and collegial corporate culture.</li> <li>Demonstrated success working in a high-performing, results-driven environment.</li> <li>Ability to work independently and to communicate legal issues and solutions clearly and concisely.</li> <li>Excellent verbal and written communication skills.</li> <li>Analytical and research skills required.</li> </ul> <p> </p> <p> </p> <p><strong> </strong></p> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
3 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Sr. Manager/Associate Director, Quality Assurance Open Quality Redwood City, CA, United States Redwood City CA USA Feb 12th, 2019 12:00AM <p><strong>Overview: </strong></p> <p>Representing the quality organization in oversight and monitoring of the GMP production in contract manufacturing sites to ensure product specifications are met.</p> <p><strong>Principle Responsibilities and Duties: </strong></p> <ul> <li>Review and approval of batch records to support the disposition of Coherus products</li> <li>Drives and troubleshoots quality investigations at contract manufacturers to ensure that all critical quality issues are fully investigated with appropriate action. Alert management of product quality operation issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Review.</li> <li>Manage CAPA and Change Controls to support release of products by Coherus</li> <li>Ensures contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections.</li> <li>Quality review of documents from contract manufacturers for compliance with Coherus BioSciences policies/procedures and cGMP’s.</li> <li>Execute and oversee Coherus BioSciences vendor management key performance indicators at contract manufacturers.</li> <li>Identify, maintain, and team with stakeholders across the organization &amp; at CMO’s to address compliance related issues and processes<strong>. </strong></li> <li>Ensure quality checks on operations in progress at contract manufacturers Drug Product, Device Assembly, Labeling and Final Packaged Product.</li> <li>Carry out final release activities for manufactured products.</li> <li>Provides audit support of Coherus BioSciences contract manufacturers as required.</li> <li>Identify, create and implement process and system improvements.</li> <li>Establishes and maintain programs that ensure the verification, monitoring and effectiveness of the QMS  and its compliance to applicable regulations and standards</li> <li>Participate in regularly scheduled meetings with CMOs.</li> <li>Contribute to process improvement initiatives across organization - provide support and direction to maintain quality system to recognized standards - direct and/or participate in development of QA processes and SOPs - support development of processes and SOPs by process owners outside QA</li> <li>Establish, maintain and report metrics to evaluate the Quality performance of CMOs</li> <li>Support Quality Management with other duties, as required</li> </ul> <p> </p> <p><strong>Experience, Education, Training, Traits:</strong></p> <ul> <li>Bachelor degree in Sciences, or comparable experience, with minimum of 8-10 years of experience in a GMP quality (QA/QC) environment, experience in drug product/device/labeling and final packaged product manufacturing.</li> <li>Minimum of 3-5 years of experience in managing contract manufacturing organizations and driving process improvements.</li> <li>Strong leadership and negotiation skills.</li> <li>Excellent interpersonal and communication skills.</li> <li>Exceptional ability to partner cross-functionally with different teams and projects.</li> <li>Exercise sound and independent judgment and decision making.</li> <li>Exceptional attention to detail.</li> <li>Travel to CMO site as required: Travel will be ~20-30%, typically campaign based.</li> </ul> <p>As an employee of Coherus, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and stock options reflect Coherus' high regard for our employees.</p> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
4 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Vice President, Quality Control Open Quality Redwood City, CA, United States Redwood City CA USA Apr 2nd, 2019 12:00AM <p><strong>Overview:</strong>  </p> <p>The Vice President of Quality Control will be responsible for all Quality Control activities within Company and will play an integral role in the success of the Company.  Primary responsibilities include leading the development and implementation of a comprehensive Quality management plan for Quality Control and being the lead Quality Control representative for the assigned projects; generation, review and compilation of Quality Control required reports, manuals and SOP’s; development and maintenance of Quality Agreements with key contract testing labs; serving as lead on audits and potential Agency inspections and partner due diligence evaluations and contribute to regulatory submissions.  The incumbent must have hands on experience in the development, establishment, management, and defense of Quality Control systems, both internally and externally, as well as extensive knowledge, understanding and application of Quality Control systems for combination products. Superb quality documentation generation skills and proven communication skills, as well as significant experience in the biopharmaceutical industry, are critical.  </p> <p> </p> <p><strong>Principal Responsibilities and Duties: <br> </strong>Note:  The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title<strong>:</strong></p> <ul> <li>Oversee the operations of all Quality Control activities globally for internal and external testing activities.</li> <li>Provide input and guidance to strategic partners as needed.</li> <li>Represent the Quality Control organization in interactions with other functional units. These include Regulatory Affairs, Clinical, Project Management, Manufacturing, Finance, etc.</li> <li>Establish, oversee, and manage QC documentation systems including but not limited to, change control, SOPs, protocols/reports, training records, job descriptions etc.</li> <li>Lead the implementation of a Quality Control System that will assure that all aspects of Quality Control testing are in compliance with worldwide CMC requirements as well as internal SOP’s.</li> <li>Assist the Company with the development and management of a comprehensive budget for Quality Control activities.</li> <li>Provide mentorship to direct reports and maintain clear communication on performance to direct reports</li> <li>Travel as required, both domestically and internationally, to ensure compliance to the Company’s Quality Management Systems</li> </ul> <p> </p> <p><strong>Experience, Education, Training, Traits:</strong></p> <ul> <li>BS degree in relevant scientific discipline or technical field is required; advanced degree is preferred.</li> <li>A minimum of 8-10 years' hands on experience in a Quality organization within the biotechnology industry is preferred, which shall include 5 years' hands on experience in managing Quality groups (both internal and external).</li> <li>Ability to function effectively as a member of project teams with demonstration of superior leadership skills.</li> <li>Experience with using a “phase-appropriate” approach to compliance.</li> <li>Extensive knowledge of GMP quality systems and regulatory compliance.</li> <li>Complete understanding of the commercialization of protein-based therapeutic products in the US, and preferably, Europe, Japan, and the non-ICH geographies.</li> <li>Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment.</li> <li>A hands-on, “roll up the sleeves” professional willing to try innovative things, have a driving sense of urgency and an experienced “make it happen” orientation within a Program-based, matrix work environment.</li> <li>Exceptional communication skills, both written and verbal, are required.  This candidate must have the communication skills and experience to effectively present the Company’s Quality programs to the FDA and other regulatory authorities from around the world.</li> <li>Articulate, persuasive and demonstrated ability to influence others, while employing sound judgment and good sense.  Ability to provide clear direction in a matrix managed organization.</li> <li>An exceptional leader with the strong management and leadership skills necessary to set a vision, create and lead a first class, results oriented Quality group.</li> <li>An understanding of the importance of meeting corporate and program commitments.</li> <li>Possesses the strongest ethics and integrity.</li> <li>Ability to travel both domestically and internationally, up to 25%.</li> <li>Demonstrated ability to write reports, presentations, and business correspondence and to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.</li> </ul> <p> </p> <p> </p> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
5 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Associate Director, Quality Assurance Commercial Bulk Drug Substance Open Quality Redwood City, CA, United States Redwood City CA USA Apr 1st, 2019 12:00AM <p><strong>Overview:</strong>  The Associate Director, Quality Assurance leads and directs Quality activities at Coherus that assures overall compliance that facilitates disposition, of commercial bulk drug substance.  </p> <p><strong>Principal Responsibilities and Duties: <br> </strong>Note:  The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title<strong>:</strong></p> <ul> <li>Develop operate and maintain the effectiveness of the Coherus Quality Management System (QMS) including but not limited to</li> <ul> <li>Document Control</li> <li>Deviations</li> <li>Change Control</li> <li>CAPA</li> </ul> <li>Quality Lead for Coherus commercial products</li> <li>Review, approval of batch records to support the disposition of Coherus commercial bulk drug substance</li> <li>Ensure timely identification, escalation and resolution of Critical/Major Quality issues. Alert management of product quality operation issues for proper and timely escalation to Material Review Board (MRB) and Management Review.</li> <li>Establishes and maintain programs that ensure the verification, monitoring and effectiveness of the QMS and its compliance to applicable regulations and standards.</li> <li>Participate support and guide validation activities in support of regulatory filling</li> <li>Manage the quality and compliance of Contract Manufacturing Organizations (CMOs) that allows the timely disposition of Clinical Trial Material (CTM) in support company objectives</li> <li>Assist in the preparation and update of MQA (Master Quality Agreements) to support QA operational compliance of European based CMOs</li> <li>Support late stage development activities including process validation and regulatory agency preapproval inspections (PAI) preparations</li> <li>Participate in regularly scheduled meetings with CMOs.</li> <li>Assist in on Quality audits of Coherus CMOs and  suppliers</li> <li>Provide regulatory support of Coherus products  in support company objectives</li> <li>Contribute to process improvement initiatives across organization - provide support and direction to maintain quality system to recognized standards - direct and/or participate in development of QA processes and SOPs - support development of processes and SOPs by process owners outside QA</li> <li>Participate in CMC teams supporting the filing and launch of Coherus products</li> <li>Assess and manage compliance and compliance risks, and organizational dynamics as well as their implications.</li> <li>Partner/team with stakeholders across the organization to address compliance related issues and processes.</li> <li>Establish, maintain and report metrics to evaluate the Quality performance of CMOs</li> </ul> <p><strong> </strong><strong>Experience, Education, Training, Traits:</strong></p> <ul> <li>Bachelors of Science degree or work experience equivalent to a minimum of 10 + years QA experience in the pharmaceutical/Biological industry</li> <li>Prior experience in disposition of CTM and CMO Quality oversight</li> <li>Exceptional ability to partner cross-functionally with different teams and projects.</li> <li>Strong experience in establishing and maintaining a QMS</li> <li>Strong Knowledge of FDA guidelines and regulations regarding CGMPs.</li> <li>Strong knowledge and demonstrated practice of ICH Guidelines.</li> <li>Excellent interpersonal and communication skills.</li> <li>Strong computer skills, including all MS Office applications.</li> </ul> <p><strong>Language Skills</strong></p> <p>Ability to write reports, presentations and email correspondence.  Must effectively present information and respond to correspondents from managers, program management and CMOs.</p> <p><strong>Additional Skills</strong></p> <ul> <li>Ability to operate within and simultaneously build a QMS</li> <li>Effectively interact with multi-disciplinary functional groups.</li> <li>Outstanding written and verbal skills as well as problem solving skills.</li> <li>Strong initiative and ability to assume significant project management skills.</li> <li>Ability to work in a fast-paced, dynamic environment.</li> <li>&gt;30% Travel may be required for this position.</li> </ul> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
6 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Director, CMC Regulatory Affairs Open Regulatory Redwood City, CA, United States Redwood City CA USA Feb 12th, 2019 12:00AM <p><strong>Overview:</strong>   </p> <p>In partnership with the VP, Regulatory Affairs, the Director, CMC Regulatory Affairs acts as a CMC regulatory lead for small molecules by providing regulatory strategy and support to development teams and ensuring that regulatory documents are compiled and submitted to relevant US and ex-US regulatory authorities in a timely manner.</p> <p><strong>Principle Responsibilities and Duties: </strong></p> <ul> <li>Works with VP to develop and execute CMC regulatory strategies for small molecule products in development.</li> <li>Represents CMC Regulatory Affairs at project team meetings and coordinates workflow between departments as well as CROs.</li> <li>Acts as CMC Co-Project Team Lead for key program at Coherus.</li> <li>Coordinates, writes, compiles, document packages for regulatory submissions from development and manufacturing areas per regulations/guidelines and company SOPs to support regulatory applications including investigational and marketing applications (IND, CTA, NDA, NDS, MAA), etc.</li> <li>Maintains CMC Regulatory document control system.</li> <li>Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline areas relevant to assigned projects.</li> <li>Responsible for interactions with regulatory authorities as needed for CMC matters.</li> <li>Participates in department initiatives to improve standards and systems internally and maintain relationships with other departments including consultants and vendors.</li> <li>Writes, reviews, provides regulatory and technical input and ensures that technical documents (pertaining to clinical, chemistry, manufacturing and controls, and non-clinical information) prepared in line with the company policies.</li> </ul> <p><strong>Education, Experience and Background</strong>:</p> <ul> <li>BS/MS or PhD a in life sciences field</li> <li>10+ years relevant regulatory pharmaceutical experience</li> <li>Extensive knowledge of all aspects of the Global Development process</li> <li>Experience with small molecules; biologics experience a plus</li> <li>Ability to manage multiple and varied tasks in a fast-moving environment, with excellent project management skills.</li> <li>Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, and working collaboratively with pharmaceutical partners are required.</li> <li>Must be flexible attitude and willing to learn new areas of product development.</li> <li>Must be highly collaborative, with outstanding communication</li> </ul> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
7 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Director, Commercial Quality Control Open Quality Redwood City, CA, United States Redwood City CA USA Feb 12th, 2019 12:00AM <p><strong>Overview:</strong>   </p> <p>The  Director, Commercial Quality Control will be responsible for all Quality Control procedures and systems for Coherus’ commercial manufacturing and testing CMO network.  Primary responsibilities include oversight of commercial testing, test demand/capacity, and testing cycle time reductions.  The incumbent would be the single point of Contact for the Company with the commercial testing network and will be responsible for the generation, review and compilation of Quality Control required reports, manuals and SOP’s; development and maintenance of Quality Agreements with key commercial contract testing labs.  The incumbent must have hands on experience in the development, establishment, management, and defense of commercial Quality Control systems. Superb quality documentation generation skills and proven communication skills, as well as significant experience in the biopharmaceutical industry, are critical.  </p> <p><strong>Principle Responsibilities and Duties: <br> </strong>Represent Quality Control on internal project teams and represent Coherus Quality Control to Contract Laboratory Quality counterparts. Develop and review product Certificate of Analysis, Test methods and assay history records. Assist in audits as needed and represent Coherus during regulatory inspections of contract laboratories.  Independently manage method transfer process effectively to deliver analytical methods for protein therapeutics from one site to another.  Coordinate validation and testing activities for release, stability and in-process methods to support the manufacture of protein therapeutic product suitable for FDA and other regulatory agency licensure.    </p> <p><strong>Specific duties:</strong></p> <ul> <li style="padding-left: 30px;">Oversee the operations of all commercial Quality Control activities globally for internal and external testing activities.</li> <li style="padding-left: 30px;">Oversee and support method validation and verification activities, and method transfer between sites</li> <li style="padding-left: 30px;">Represent the Quality Control organization in interactions with other key commercial functional units as well as with external contract testing labs.</li> <li style="padding-left: 30px;">Manage deviations, CAPAs, and change controls for commercial Coherus products.</li> <li style="padding-left: 30px;">Develop Coherus commercial Quality Control standards/process as member of the QC team.</li> <li style="padding-left: 30px;">Conduct GMP audits of commercial CMO’s and testing laboratories.</li> <li style="padding-left: 30px;">Serve as Coherus liaison during regulatory inspections of contract labs.</li> <li style="padding-left: 30px;">Lead and /or review laboratory deviation evaluation and resolution activities as requiredProvide mentorship to direct reports and maintain clear communication on performance to direct reports.</li> <li style="padding-left: 30px;">Travel as required, both domestically and internationally, to ensure compliance to the Company’s Quality Management Systems.</li> </ul> <p><strong>Experience, Education, Training, Traits:</strong></p> <ul> <li style="padding-left: 30px;">Bachelors’ degree in Engineering, Chemical or Life Sciences. Advanced degree preferred.</li> <li style="padding-left: 30px;">A minimum of 8-10 years' hands on experience in a Quality organization within the biotechnology industry is preferred, which shall include 5 years' hands on experience in managing Quality groups (both internal and external).</li> <li style="padding-left: 30px;">Expert knowledge of global cGMP expectations, ICH Quality requirements, and USP/EP/JP.</li> <li style="padding-left: 30px;">Complete understanding of the commercialization of protein-based therapeutic products in the US, and preferably, Europe, Japan, and the non-ICH geographies.</li> <li style="padding-left: 30px;">Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment.</li> <li style="padding-left: 30px;">A hands-on, “roll up the sleeves” professional willing to try innovative things, have a driving sense of urgency and an experienced “make it happen” orientation within a Program-based, matrix work environment.</li> <li style="padding-left: 30px;">Expert analytical method development experience highly desired.</li> <li style="padding-left: 30px;">Ability to travel both domestically and internationally, up to 25%.</li> <li style="padding-left: 30px;">Demonstrated ability to write reports, presentations, and business correspondence and to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.</li> <li style="padding-left: 30px;">Comfortable working in a fast paced and highly expert environment.</li> <li style="padding-left: 30px;">Excellent communication skills and comfortable assuming leadership within teams and with external CMO’s.</li> </ul> <p> </p> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
8 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Director/Sr. Director, Clinical Operations Open Clinical Redwood City, CA, United States Redwood City CA USA Apr 9th, 2019 12:00AM <p><strong>Overview:</strong>   </p> <p>This position will oversee the clinical operations team responsible for execution of global clinical studies for product(s) in a related therapeutic area.</p> <p><strong>Principal Responsibilities and Duties: </strong></p> <p>Oversee the management of the Company’s CROs, central laboratories, vendors and global clinical sites to enable smooth, timely study execution from study initiation to close out. </p> <ul> <li>Develop protocols which can be implemented by the CRO and ensure adherence to all documentation requirements and process.</li> <li>Set and manage well defined clinical project timelines and milestones with the CRO, VP, Clinical Development and executive team, escalating issues that may jeopardize timelines and deliverables.</li> <li>Work with VP, Clinical Operations and Finance to develop budgets, accruals and track the financial status against budget.</li> <li>Work with CROs to ensure that milestones and deliverables are well defined and achieved.</li> <li>Oversee study logistics and monitoring activities, including patient recruitment, screening and enrollment.</li> <li>Interact with active and potential clinical investigators.</li> <li>Manage study monitoring, leveraging partnerships with CROs and regional monitors as necessary.</li> <li>Organize/run meetings and teleconferences for clinical studies.</li> <li>Liaise with other functional areas, such as Regulatory Affairs and Clinical Supply Chain in order to accurately coordinate clinical study activity.</li> <li>Contribute to the writing and review of protocols, clinical study reports and clinical sections of the Investigator’s Brochure, INDs/CTAs and BLAs/MAAs.</li> <li>Represent Clinical Operations on the Product Development Team</li> <li>Maintain up-to-date knowledge of clinical principles and theories of drug development and study design in relevant therapeutic areas</li> <li>In collaboration with other Coherus clinical staff and departments ensure the clinical studies are conducted in compliance with Federal, State and local regulations, Good Clinical Practice regulations and internal Standard Operating Procedures.</li> <li>May act as primary liaison with clinical teams of development partners on assigned studies/program.</li> <li>Develop Standard Operating Procedures (SOPs) and study-specific guidelines as needed.</li> <li>Organize work and resources for Clinical Operations department including outside partners as necessary to achieve clinical development and corporate goals.</li> <li>Travel as required, approximately 30% - 40%</li> </ul> <p><strong>Background and Experience:</strong></p> <ul> <li>BS in life sciences</li> <li>10+ years of experience of biotech/pharmaceutical experience, including managing CRO contracts and ongoing relationships.</li> <li>Must have experience performing both small Phase 1 studies and larger, global trial management.</li> <li>Experience in the execution of inflammation or oncology-related clinical trials preferred</li> <li>Familiarity with GCP and applicable FDA/EMEA regulations is required.</li> <li>Ability to prepare and present clinical trial updates to senior management.</li> <li>Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects.</li> <li>Ability to learn quickly, be flexible and apply new skills, procedures and approaches.</li> <li>Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision.</li> <li>Excellent organizational skills and the ability to apply superior attention to detail and organization skills in all aspects of work.</li> <li>Understanding of data management, statistics and medical writing processes.</li> <li>Ability to travel domestically and internationally.  Some travel will take place on/over weekends.</li> <li>Strong computer skills, including all MS Office applications.</li> </ul> <h3> </h3> <p><strong> </strong></p> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
9 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Senior Auditor, Clinical Quality Assurance Open Quality Redwood City, CA, United States Redwood City CA USA Apr 1st, 2019 12:00AM <p><strong>Overview:</strong>   The Clinical Quality Assurance (CQA) Sr. Auditor will be responsible for supporting the CQA department in assuring that, for Coherus studies, Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) standards are met. The Sr. Auditor, Clinical QA will be a critical team member who contributes to the implementation of risk-based GCP and GCLP audit programs and compliance oversight and also supports inspection readiness activities.</p> <p><strong>Principle Responsibilities and Duties: </strong></p> <ul> <li>Represent CQA on internal project teams and with external Clinical Service Providers.</li> <li>Ensure that systems, records, and CQA service providers are compliant with global GCP and GCLP requirements.</li> <li>Work closely with and support the clinical functions such as Clinical Operations and Translational and Development Sciences.</li> <li>Plan, conduct, and report internal and external CQA audits.</li> <li>Oversee/manage contract auditors.</li> <li>Participate in tracking and trending activities and generate metrics, reports and overviews.</li> <li>Assist with inspection readiness activities.</li> <li>Assist with study-specific risk management planning and oversight.</li> <li>Develop and review written procedures.</li> <li>Conduct clinical document review (e.g. protocols, study plans, source document worksheets, and clinical study reports).</li> <li>Participate in the identification, assessment, and reporting of Clinical Quality Events and CAPAs.</li> <li>Participate in Clinical Service Provider qualification activities.</li> <li>Prepare Quality Agreements with Clinical Service Providers.</li> <li>Prepare and conduct GCP and GCLP training.</li> <li>Support CQA projects.</li> <li>Provide administrative support including; maintaining audit logs, maintaining audit and inspection records, generating reports, creating templates and others as needed.</li> </ul> <p> </p> <p><strong>Experience, Education, Training, Traits:</strong></p> <ul> <li>Bachelors’ degree in a scientific field</li> <li>5 years or greater experience in Biotechnology with at least two years in CQA</li> <li>Experience as a Lead Auditor for GCP and GCLP Audits</li> <li>Strong knowledge of global GCP and GCLP regulations and standards</li> <li>Excellent collaboration skills.</li> <li>Ability to work independently</li> <li>Excellent attention to detail</li> <li>Comfortable working in a fast paced and highly expert environment.</li> <li>Excellent written and verbal communication skills</li> <li>Comfortable assuming leadership within teams and for projects.</li> <li>Must be able to travel up to 30%</li> </ul> <p><strong> </strong></p> <p><strong>Physical Requirements</strong></p> <p>While performing the duties of this job, the employee may be required to perform lifting tasks of up to 10 pounds for short durations.  Duties of this job may involve standing and/or walking for extended periods of time.  Duties also involve daily keyboard data entry.  Specific vision abilities required by this job include close vision and color vision.</p> <p><strong>Safety</strong></p> <p>Coherus is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.</p> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology
10 nasdaq:chrs www.coherus.com www.coherus.com Apr 10th, 2019 12:00AM Senior Clinical Research Associate Open Clinical Redwood City, CA, United States Redwood City CA USA Apr 9th, 2019 12:00AM <p><strong>Overview:</strong></p> <p>Coherus BioSciences is a leading biologics platform company primarily focused on delivering high-quality biosimilar therapeutics that will expand patient access to life-altering medicines in regulated markets worldwide. Our platform includes world-class capabilities in process science, analytical characterization, protein production, and clinical and regulatory development.</p> <p>This position will work with the Coherus clinical team to support execution of global clinical studies for Coherus’ various products.  Depending on project complexity and level of experience, this may include supporting one or more clinical studies and/or managing a multi-national region for multiple global clinical studies.  This position will assist in supporting the lead CPM in the oversite of contract research organizations, clinical laboratories, and other vendors, including clinical sites; collaborate with clinical development partners, as well as other internal departments to ensure that the clinical studies are conducted on time and within budget.  This position will also assist with the development of processes and infrastructure within clinical operations.</p> <p><strong>Principal Responsibilities and Duties: </strong></p> <ul> <li>Collaborate with other Coherus functional areas and consultants, such as Drug Planning, Project Management, Finance, Quality Systems, and Regulatory Affairs in order to successfully coordinate assigned clinical study/program.</li> <li>Provide support to CROs and vendors for assigned clinical study/programs, providing Coherus representation and ensuring adherence to project scope, deliverables and timelines.</li> <li>Assist with study start up with CROs and clinical sites as necessary, including, working closely with CRO to complete template clinical documents, such as, ICF, source document worksheets, CRF specifications and development, clinical site agreements, and other study documentation.</li> <li>Assist with clinical study team meetings and teleconferences.</li> <li>Support study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved; recognize and escalate issues that may jeopardize timelines and deliverables, or lead to out of scope expenses.</li> <li>Track and report clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory (PK/PD/ADA) data, data cleaning status for assigned clinical study/program, etc.</li> <li>May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff, and/or with compliance personnel, including pre-study qualification visits, site initiation visits, routine study visits, trial master file review visits, vendor qualification or selection visits etc.</li> <li>Ensure adherence to all documentation requirements and process at the CRO(s), all other vendors and within Coherus.</li> <li>Monitor the maintenance of the clinical trial master files per SOPs and GCP, at the CRO(s) and vendors. Review clinical study files for completeness periodically throughout and at the completion of clinical trials and prior to archiving.  Set-up and manage necessary portions of the trial master file in-house for assigned clinical study/program.</li> <li>Coordinate the RFP process, review vendor proposals, and negotiate budgets for assigned clinical study/program.</li> <li>In collaboration with Finance, assist in the development, forecasting, monitoring, and reporting of assigned clinical study/program budgets.</li> <li>In collaboration with other Coherus clinical staff and departments ensure the clinical studies are conducted in compliance with Federal, State and local regulations, Good Clinical Practice regulations and internal Standard Operating Procedures.</li> <li>Contribute to the writing and implementation of Standard Operating Procedures (SOPs), standard forms and study-specific guidelines to support clinical operations.</li> <li>Travel as required to domestic and international development partners, CROs, vendors, and clinical sites, as needed.</li> </ul> <p><strong>Background and Experience:</strong></p> <ul> <li>BS in life sciences.</li> <li>7+ years of experience of biotech/pharmaceutical clinical operations experience</li> <li>Strong experience in CRO and vendor management to support global clinical trials</li> <li>Understanding of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.</li> <li>Demonstrated skills in writing/reviewing clinical study protocols, CRF designs, CSRs, regulatory documents (including IND/CTA, marketing application documents and annual/periodic updates) and developing study documentation.</li> <li>Understanding of data management, statistics and medical writing processes for clinical development.</li> <li>Ability to “roll up your sleeves” and individually contribute results to clinical operations and company-wide goals</li> <li>Team-oriented with excellent communication and interpersonal skills, including a positive and professional attitude to tasks and projects.</li> <li>Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision.</li> <li>Demonstrated computer skills using MS Office Suite (MS Word, Excel, PowerPoint, MS Outlook, and MS Project) software.</li> <li>Perform other related tasks as requested.</li> </ul> Apr 10th, 2019 01:35AM Apr 10th, 2019 01:35AM Health Care Pharmaceuticals & Biotechnology

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