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Axovant Sciences

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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:axon www.axovant.com www.axovant.com Jul 5th, 2018 12:00AM Manager, Process Development Open CMC New York, NY New York NY USA Jun 27th, 2018 12:00AM <p><strong>JOB SUMMARY</strong></p> <p>The Roivant Sciences, Inc. Pharmaceutical Development and Manufacturing organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs - both NCEs and biopharmaceuticals - and drug products – solid and parenteral dosage forms.  A significant component of these development activities are the synthetic methods required to develop and register these critical medicines.  The development and manufacturing activities are conducted through CMOs, where appropriate synthetic processes are required to control the quality of raw materials, intermediates and final products.  The ideal candidate is expected to support synthetic development of small molecule candidates from Phase I through NDA.</p> <p>The Manager, Process Development, will be responsible for CMC technical activities with drug substance, as well as synthetic activities conducted at CMOs for process development, optimization, CPP identification, QbD/DOE, technology transfer, manufacturing and validation.  In some instances, the individual will need to work with CMOs to innovate new synthetic routes and reactions where needed.  Specifically, the candidate will demonstrate a proven track record of managing CMOs to develop manufacturing routes and processes and quality control strategies to support Phase I to commercial launch.  Experience with IND filing and NDA submissions desired.</p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Execute CMC regulatory strategy for Drug Substance, including:</li> <ul> <li>Authoring, Requests for Proposals and leading the CDMO selection process</li> <li>Leading technology transfer activities, process development, scale up and oversight of manufacturing activities at the CDMO</li> <li>Collaborating with Quality Assurance to ensure all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.</li> <li>Supporting batch record review, investigations, deviations and change controls as needed.</li> </ul> <li>Liaise with cross-functional teams (QA, Regulatory, as well as other CMC functions, Clinical and Toxicology) to ensure consistency of methods, specifications and manufacturing control during Drug Substance scale-up.  Work with cross- functional teams to assure the quality of final Drug Substance used for non-clinical and clinical studies, registration and validation activities</li> <li>Support phase-appropriate control using appropriate process development strategies; manage product stability and reference standard programs; ensure that all methods for starting materials, intermediates, in-process controls, and final drug substance are adequate for the control of process-related impurities</li> <li>Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression; serve as the CMC representative in cross-functional project teams</li> <li>Author and/or review development and validation reports and API sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA, BLA submissions, briefing books, DMF, and other regulatory submission documents and updates</li> <li>Assist in troubleshooting drug substance manufacturing processes when required</li> <li>Ensure proper communication and reporting to the CMC organization, CMC leads, and other functions</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>BS/MS in Synthetic Chemistry or equivalent, with a minimum of 8 years in chemical development experience including hands-on manufacturing expertise (particularly small molecule)</li> <li>Experience throughout the development/commercial continuum preferred, including technology transfer, scale up, process validation and commercial manufacturing</li> <li>Detailed knowledge of ICH, FDA, EMA regulations focused on CMC development</li> <li>Global CMC requirements knowledge is desirable</li> <li>Experience overseeing external development and manufacturing vendors</li> <li>Comfort working in a dynamic, fast-paced environment, interacting with internal and external teams and flexibility in supporting clinical and commercial development and manufacturing needs</li> <li>Expertise with DoE, risk assessments and FMEAs is preferred.</li> <li>Experience in the preparation of CMC sections for regulatory filings preferred</li> <li>Excellent communication (written and oral) and organizational skills</li> <li>Excellent skills required in Microsoft Word, Excel, Project and Adobe Acrobat</li> </ul> <p><strong>PERSONAL ATTRIBUTES</strong></p> <ul> <li>Demonstrated alignment with Roivant values and culture</li> <li>Attention to detail, focus on goals, and ability to work in a cross-functional team</li> <li>Ability to travel up to 20-30% of time</li> </ul> <p>#LI-JM1</p> Jul 4th, 2018 10:19PM Jul 4th, 2018 10:19PM
2 nasdaq:axon www.axovant.com www.axovant.com Jul 4th, 2018 12:00AM Manager, Process Development Open CMC New York, NY New York NY USA Jun 27th, 2018 12:00AM <p><strong>JOB SUMMARY</strong></p> <p>The Roivant Sciences, Inc. Pharmaceutical Development and Manufacturing organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs - both NCEs and biopharmaceuticals - and drug products – solid and parenteral dosage forms.  A significant component of these development activities are the synthetic methods required to develop and register these critical medicines.  The development and manufacturing activities are conducted through CMOs, where appropriate synthetic processes are required to control the quality of raw materials, intermediates and final products.  The ideal candidate is expected to support synthetic development of small molecule candidates from Phase I through NDA.</p> <p>The Manager, Process Development, will be responsible for CMC technical activities with drug substance, as well as synthetic activities conducted at CMOs for process development, optimization, CPP identification, QbD/DOE, technology transfer, manufacturing and validation.  In some instances, the individual will need to work with CMOs to innovate new synthetic routes and reactions where needed.  Specifically, the candidate will demonstrate a proven track record of managing CMOs to develop manufacturing routes and processes and quality control strategies to support Phase I to commercial launch.  Experience with IND filing and NDA submissions desired.</p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Execute CMC regulatory strategy for Drug Substance, including:</li> <ul> <li>Authoring, Requests for Proposals and leading the CDMO selection process</li> <li>Leading technology transfer activities, process development, scale up and oversight of manufacturing activities at the CDMO</li> <li>Collaborating with Quality Assurance to ensure all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.</li> <li>Supporting batch record review, investigations, deviations and change controls as needed.</li> </ul> <li>Liaise with cross-functional teams (QA, Regulatory, as well as other CMC functions, Clinical and Toxicology) to ensure consistency of methods, specifications and manufacturing control during Drug Substance scale-up.  Work with cross- functional teams to assure the quality of final Drug Substance used for non-clinical and clinical studies, registration and validation activities</li> <li>Support phase-appropriate control using appropriate process development strategies; manage product stability and reference standard programs; ensure that all methods for starting materials, intermediates, in-process controls, and final drug substance are adequate for the control of process-related impurities</li> <li>Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression; serve as the CMC representative in cross-functional project teams</li> <li>Author and/or review development and validation reports and API sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA, BLA submissions, briefing books, DMF, and other regulatory submission documents and updates</li> <li>Assist in troubleshooting drug substance manufacturing processes when required</li> <li>Ensure proper communication and reporting to the CMC organization, CMC leads, and other functions</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>BS/MS in Synthetic Chemistry or equivalent, with a minimum of 8 years in chemical development experience including hands-on manufacturing expertise (particularly small molecule)</li> <li>Experience throughout the development/commercial continuum preferred, including technology transfer, scale up, process validation and commercial manufacturing</li> <li>Detailed knowledge of ICH, FDA, EMA regulations focused on CMC development</li> <li>Global CMC requirements knowledge is desirable</li> <li>Experience overseeing external development and manufacturing vendors</li> <li>Comfort working in a dynamic, fast-paced environment, interacting with internal and external teams and flexibility in supporting clinical and commercial development and manufacturing needs</li> <li>Expertise with DoE, risk assessments and FMEAs is preferred.</li> <li>Experience in the preparation of CMC sections for regulatory filings preferred</li> <li>Excellent communication (written and oral) and organizational skills</li> <li>Excellent skills required in Microsoft Word, Excel, Project and Adobe Acrobat</li> </ul> <p><strong>PERSONAL ATTRIBUTES</strong></p> <ul> <li>Demonstrated alignment with Roivant values and culture</li> <li>Attention to detail, focus on goals, and ability to work in a cross-functional team</li> <li>Ability to travel up to 20-30% of time</li> </ul> <p>#LI-JM1</p> Jul 3rd, 2018 10:22PM Jul 3rd, 2018 10:22PM
3 nasdaq:axon www.axovant.com www.axovant.com Jul 3rd, 2018 12:00AM Manager, Process Development Open CMC New York, NY New York NY USA Jun 27th, 2018 12:00AM <p><strong>JOB SUMMARY</strong></p> <p>The Roivant Sciences, Inc. Pharmaceutical Development and Manufacturing organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs - both NCEs and biopharmaceuticals - and drug products – solid and parenteral dosage forms.  A significant component of these development activities are the synthetic methods required to develop and register these critical medicines.  The development and manufacturing activities are conducted through CMOs, where appropriate synthetic processes are required to control the quality of raw materials, intermediates and final products.  The ideal candidate is expected to support synthetic development of small molecule candidates from Phase I through NDA.</p> <p>The Manager, Process Development, will be responsible for CMC technical activities with drug substance, as well as synthetic activities conducted at CMOs for process development, optimization, CPP identification, QbD/DOE, technology transfer, manufacturing and validation.  In some instances, the individual will need to work with CMOs to innovate new synthetic routes and reactions where needed.  Specifically, the candidate will demonstrate a proven track record of managing CMOs to develop manufacturing routes and processes and quality control strategies to support Phase I to commercial launch.  Experience with IND filing and NDA submissions desired.</p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Execute CMC regulatory strategy for Drug Substance, including:</li> <ul> <li>Authoring, Requests for Proposals and leading the CDMO selection process</li> <li>Leading technology transfer activities, process development, scale up and oversight of manufacturing activities at the CDMO</li> <li>Collaborating with Quality Assurance to ensure all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.</li> <li>Supporting batch record review, investigations, deviations and change controls as needed.</li> </ul> <li>Liaise with cross-functional teams (QA, Regulatory, as well as other CMC functions, Clinical and Toxicology) to ensure consistency of methods, specifications and manufacturing control during Drug Substance scale-up.  Work with cross- functional teams to assure the quality of final Drug Substance used for non-clinical and clinical studies, registration and validation activities</li> <li>Support phase-appropriate control using appropriate process development strategies; manage product stability and reference standard programs; ensure that all methods for starting materials, intermediates, in-process controls, and final drug substance are adequate for the control of process-related impurities</li> <li>Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression; serve as the CMC representative in cross-functional project teams</li> <li>Author and/or review development and validation reports and API sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA, BLA submissions, briefing books, DMF, and other regulatory submission documents and updates</li> <li>Assist in troubleshooting drug substance manufacturing processes when required</li> <li>Ensure proper communication and reporting to the CMC organization, CMC leads, and other functions</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>BS/MS in Synthetic Chemistry or equivalent, with a minimum of 8 years in chemical development experience including hands-on manufacturing expertise (particularly small molecule)</li> <li>Experience throughout the development/commercial continuum preferred, including technology transfer, scale up, process validation and commercial manufacturing</li> <li>Detailed knowledge of ICH, FDA, EMA regulations focused on CMC development</li> <li>Global CMC requirements knowledge is desirable</li> <li>Experience overseeing external development and manufacturing vendors</li> <li>Comfort working in a dynamic, fast-paced environment, interacting with internal and external teams and flexibility in supporting clinical and commercial development and manufacturing needs</li> <li>Expertise with DoE, risk assessments and FMEAs is preferred.</li> <li>Experience in the preparation of CMC sections for regulatory filings preferred</li> <li>Excellent communication (written and oral) and organizational skills</li> <li>Excellent skills required in Microsoft Word, Excel, Project and Adobe Acrobat</li> </ul> <p><strong>PERSONAL ATTRIBUTES</strong></p> <ul> <li>Demonstrated alignment with Roivant values and culture</li> <li>Attention to detail, focus on goals, and ability to work in a cross-functional team</li> <li>Ability to travel up to 20-30% of time</li> </ul> <p>#LI-JM1</p> Jul 2nd, 2018 10:20PM Jul 2nd, 2018 10:20PM
4 nasdaq:axon www.axovant.com www.axovant.com Jul 2nd, 2018 12:00AM Manager, Process Development Open CMC New York, NY New York NY USA Jun 27th, 2018 12:00AM <p><strong>JOB SUMMARY</strong></p> <p>The Roivant Sciences, Inc. Pharmaceutical Development and Manufacturing organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs - both NCEs and biopharmaceuticals - and drug products – solid and parenteral dosage forms.  A significant component of these development activities are the synthetic methods required to develop and register these critical medicines.  The development and manufacturing activities are conducted through CMOs, where appropriate synthetic processes are required to control the quality of raw materials, intermediates and final products.  The ideal candidate is expected to support synthetic development of small molecule candidates from Phase I through NDA.</p> <p>The Manager, Process Development, will be responsible for CMC technical activities with drug substance, as well as synthetic activities conducted at CMOs for process development, optimization, CPP identification, QbD/DOE, technology transfer, manufacturing and validation.  In some instances, the individual will need to work with CMOs to innovate new synthetic routes and reactions where needed.  Specifically, the candidate will demonstrate a proven track record of managing CMOs to develop manufacturing routes and processes and quality control strategies to support Phase I to commercial launch.  Experience with IND filing and NDA submissions desired.</p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Execute CMC regulatory strategy for Drug Substance, including:</li> <ul> <li>Authoring, Requests for Proposals and leading the CDMO selection process</li> <li>Leading technology transfer activities, process development, scale up and oversight of manufacturing activities at the CDMO</li> <li>Collaborating with Quality Assurance to ensure all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.</li> <li>Supporting batch record review, investigations, deviations and change controls as needed.</li> </ul> <li>Liaise with cross-functional teams (QA, Regulatory, as well as other CMC functions, Clinical and Toxicology) to ensure consistency of methods, specifications and manufacturing control during Drug Substance scale-up.  Work with cross- functional teams to assure the quality of final Drug Substance used for non-clinical and clinical studies, registration and validation activities</li> <li>Support phase-appropriate control using appropriate process development strategies; manage product stability and reference standard programs; ensure that all methods for starting materials, intermediates, in-process controls, and final drug substance are adequate for the control of process-related impurities</li> <li>Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression; serve as the CMC representative in cross-functional project teams</li> <li>Author and/or review development and validation reports and API sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA, BLA submissions, briefing books, DMF, and other regulatory submission documents and updates</li> <li>Assist in troubleshooting drug substance manufacturing processes when required</li> <li>Ensure proper communication and reporting to the CMC organization, CMC leads, and other functions</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>BS/MS in Synthetic Chemistry or equivalent, with a minimum of 8 years in chemical development experience including hands-on manufacturing expertise (particularly small molecule)</li> <li>Experience throughout the development/commercial continuum preferred, including technology transfer, scale up, process validation and commercial manufacturing</li> <li>Detailed knowledge of ICH, FDA, EMA regulations focused on CMC development</li> <li>Global CMC requirements knowledge is desirable</li> <li>Experience overseeing external development and manufacturing vendors</li> <li>Comfort working in a dynamic, fast-paced environment, interacting with internal and external teams and flexibility in supporting clinical and commercial development and manufacturing needs</li> <li>Expertise with DoE, risk assessments and FMEAs is preferred.</li> <li>Experience in the preparation of CMC sections for regulatory filings preferred</li> <li>Excellent communication (written and oral) and organizational skills</li> <li>Excellent skills required in Microsoft Word, Excel, Project and Adobe Acrobat</li> </ul> <p><strong>PERSONAL ATTRIBUTES</strong></p> <ul> <li>Demonstrated alignment with Roivant values and culture</li> <li>Attention to detail, focus on goals, and ability to work in a cross-functional team</li> <li>Ability to travel up to 20-30% of time</li> </ul> <p>#LI-JM1</p> Jul 1st, 2018 10:19PM Jul 1st, 2018 10:19PM
5 nasdaq:axon www.axovant.com www.axovant.com Jul 1st, 2018 12:00AM Manager, Process Development Open CMC New York, NY New York NY USA Jun 27th, 2018 12:00AM <p><strong>JOB SUMMARY</strong></p> <p>The Roivant Sciences, Inc. Pharmaceutical Development and Manufacturing organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs - both NCEs and biopharmaceuticals - and drug products – solid and parenteral dosage forms.  A significant component of these development activities are the synthetic methods required to develop and register these critical medicines.  The development and manufacturing activities are conducted through CMOs, where appropriate synthetic processes are required to control the quality of raw materials, intermediates and final products.  The ideal candidate is expected to support synthetic development of small molecule candidates from Phase I through NDA.</p> <p>The Manager, Process Development, will be responsible for CMC technical activities with drug substance, as well as synthetic activities conducted at CMOs for process development, optimization, CPP identification, QbD/DOE, technology transfer, manufacturing and validation.  In some instances, the individual will need to work with CMOs to innovate new synthetic routes and reactions where needed.  Specifically, the candidate will demonstrate a proven track record of managing CMOs to develop manufacturing routes and processes and quality control strategies to support Phase I to commercial launch.  Experience with IND filing and NDA submissions desired.</p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Execute CMC regulatory strategy for Drug Substance, including:</li> <ul> <li>Authoring, Requests for Proposals and leading the CDMO selection process</li> <li>Leading technology transfer activities, process development, scale up and oversight of manufacturing activities at the CDMO</li> <li>Collaborating with Quality Assurance to ensure all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.</li> <li>Supporting batch record review, investigations, deviations and change controls as needed.</li> </ul> <li>Liaise with cross-functional teams (QA, Regulatory, as well as other CMC functions, Clinical and Toxicology) to ensure consistency of methods, specifications and manufacturing control during Drug Substance scale-up.  Work with cross- functional teams to assure the quality of final Drug Substance used for non-clinical and clinical studies, registration and validation activities</li> <li>Support phase-appropriate control using appropriate process development strategies; manage product stability and reference standard programs; ensure that all methods for starting materials, intermediates, in-process controls, and final drug substance are adequate for the control of process-related impurities</li> <li>Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression; serve as the CMC representative in cross-functional project teams</li> <li>Author and/or review development and validation reports and API sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA, BLA submissions, briefing books, DMF, and other regulatory submission documents and updates</li> <li>Assist in troubleshooting drug substance manufacturing processes when required</li> <li>Ensure proper communication and reporting to the CMC organization, CMC leads, and other functions</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>BS/MS in Synthetic Chemistry or equivalent, with a minimum of 8 years in chemical development experience including hands-on manufacturing expertise (particularly small molecule)</li> <li>Experience throughout the development/commercial continuum preferred, including technology transfer, scale up, process validation and commercial manufacturing</li> <li>Detailed knowledge of ICH, FDA, EMA regulations focused on CMC development</li> <li>Global CMC requirements knowledge is desirable</li> <li>Experience overseeing external development and manufacturing vendors</li> <li>Comfort working in a dynamic, fast-paced environment, interacting with internal and external teams and flexibility in supporting clinical and commercial development and manufacturing needs</li> <li>Expertise with DoE, risk assessments and FMEAs is preferred.</li> <li>Experience in the preparation of CMC sections for regulatory filings preferred</li> <li>Excellent communication (written and oral) and organizational skills</li> <li>Excellent skills required in Microsoft Word, Excel, Project and Adobe Acrobat</li> </ul> <p><strong>PERSONAL ATTRIBUTES</strong></p> <ul> <li>Demonstrated alignment with Roivant values and culture</li> <li>Attention to detail, focus on goals, and ability to work in a cross-functional team</li> <li>Ability to travel up to 20-30% of time</li> </ul> <p>#LI-JM1</p> Jun 30th, 2018 10:19PM Jun 30th, 2018 10:19PM
6 nasdaq:axon www.axovant.com www.axovant.com Jun 30th, 2018 12:00AM Manager, Process Development Open CMC New York, NY New York NY USA Jun 27th, 2018 12:00AM <p><strong>JOB SUMMARY</strong></p> <p>The Roivant Sciences, Inc. Pharmaceutical Development and Manufacturing organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs - both NCEs and biopharmaceuticals - and drug products – solid and parenteral dosage forms.  A significant component of these development activities are the synthetic methods required to develop and register these critical medicines.  The development and manufacturing activities are conducted through CMOs, where appropriate synthetic processes are required to control the quality of raw materials, intermediates and final products.  The ideal candidate is expected to support synthetic development of small molecule candidates from Phase I through NDA.</p> <p>The Manager, Process Development, will be responsible for CMC technical activities with drug substance, as well as synthetic activities conducted at CMOs for process development, optimization, CPP identification, QbD/DOE, technology transfer, manufacturing and validation.  In some instances, the individual will need to work with CMOs to innovate new synthetic routes and reactions where needed.  Specifically, the candidate will demonstrate a proven track record of managing CMOs to develop manufacturing routes and processes and quality control strategies to support Phase I to commercial launch.  Experience with IND filing and NDA submissions desired.</p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Execute CMC regulatory strategy for Drug Substance, including:</li> <ul> <li>Authoring, Requests for Proposals and leading the CDMO selection process</li> <li>Leading technology transfer activities, process development, scale up and oversight of manufacturing activities at the CDMO</li> <li>Collaborating with Quality Assurance to ensure all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.</li> <li>Supporting batch record review, investigations, deviations and change controls as needed.</li> </ul> <li>Liaise with cross-functional teams (QA, Regulatory, as well as other CMC functions, Clinical and Toxicology) to ensure consistency of methods, specifications and manufacturing control during Drug Substance scale-up.  Work with cross- functional teams to assure the quality of final Drug Substance used for non-clinical and clinical studies, registration and validation activities</li> <li>Support phase-appropriate control using appropriate process development strategies; manage product stability and reference standard programs; ensure that all methods for starting materials, intermediates, in-process controls, and final drug substance are adequate for the control of process-related impurities</li> <li>Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression; serve as the CMC representative in cross-functional project teams</li> <li>Author and/or review development and validation reports and API sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA, BLA submissions, briefing books, DMF, and other regulatory submission documents and updates</li> <li>Assist in troubleshooting drug substance manufacturing processes when required</li> <li>Ensure proper communication and reporting to the CMC organization, CMC leads, and other functions</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>BS/MS in Synthetic Chemistry or equivalent, with a minimum of 8 years in chemical development experience including hands-on manufacturing expertise (particularly small molecule)</li> <li>Experience throughout the development/commercial continuum preferred, including technology transfer, scale up, process validation and commercial manufacturing</li> <li>Detailed knowledge of ICH, FDA, EMA regulations focused on CMC development</li> <li>Global CMC requirements knowledge is desirable</li> <li>Experience overseeing external development and manufacturing vendors</li> <li>Comfort working in a dynamic, fast-paced environment, interacting with internal and external teams and flexibility in supporting clinical and commercial development and manufacturing needs</li> <li>Expertise with DoE, risk assessments and FMEAs is preferred.</li> <li>Experience in the preparation of CMC sections for regulatory filings preferred</li> <li>Excellent communication (written and oral) and organizational skills</li> <li>Excellent skills required in Microsoft Word, Excel, Project and Adobe Acrobat</li> </ul> <p><strong>PERSONAL ATTRIBUTES</strong></p> <ul> <li>Demonstrated alignment with Roivant values and culture</li> <li>Attention to detail, focus on goals, and ability to work in a cross-functional team</li> <li>Ability to travel up to 20-30% of time</li> </ul> <p>#LI-JM1</p> Jun 29th, 2018 10:24PM Jun 29th, 2018 10:24PM
7 nasdaq:axon www.axovant.com www.axovant.com Jun 29th, 2018 12:00AM Manager, Process Development Open CMC New York, NY New York NY USA Jun 27th, 2018 12:00AM <p><strong>JOB SUMMARY</strong></p> <p>The Roivant Sciences, Inc. Pharmaceutical Development and Manufacturing organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs - both NCEs and biopharmaceuticals - and drug products – solid and parenteral dosage forms.  A significant component of these development activities are the synthetic methods required to develop and register these critical medicines.  The development and manufacturing activities are conducted through CMOs, where appropriate synthetic processes are required to control the quality of raw materials, intermediates and final products.  The ideal candidate is expected to support synthetic development of small molecule candidates from Phase I through NDA.</p> <p>The Manager, Process Development, will be responsible for CMC technical activities with drug substance, as well as synthetic activities conducted at CMOs for process development, optimization, CPP identification, QbD/DOE, technology transfer, manufacturing and validation.  In some instances, the individual will need to work with CMOs to innovate new synthetic routes and reactions where needed.  Specifically, the candidate will demonstrate a proven track record of managing CMOs to develop manufacturing routes and processes and quality control strategies to support Phase I to commercial launch.  Experience with IND filing and NDA submissions desired.</p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Execute CMC regulatory strategy for Drug Substance, including:</li> <ul> <li>Authoring, Requests for Proposals and leading the CDMO selection process</li> <li>Leading technology transfer activities, process development, scale up and oversight of manufacturing activities at the CDMO</li> <li>Collaborating with Quality Assurance to ensure all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.</li> <li>Supporting batch record review, investigations, deviations and change controls as needed.</li> </ul> <li>Liaise with cross-functional teams (QA, Regulatory, as well as other CMC functions, Clinical and Toxicology) to ensure consistency of methods, specifications and manufacturing control during Drug Substance scale-up.  Work with cross- functional teams to assure the quality of final Drug Substance used for non-clinical and clinical studies, registration and validation activities</li> <li>Support phase-appropriate control using appropriate process development strategies; manage product stability and reference standard programs; ensure that all methods for starting materials, intermediates, in-process controls, and final drug substance are adequate for the control of process-related impurities</li> <li>Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression; serve as the CMC representative in cross-functional project teams</li> <li>Author and/or review development and validation reports and API sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA, BLA submissions, briefing books, DMF, and other regulatory submission documents and updates</li> <li>Assist in troubleshooting drug substance manufacturing processes when required</li> <li>Ensure proper communication and reporting to the CMC organization, CMC leads, and other functions</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>BS/MS in Synthetic Chemistry or equivalent, with a minimum of 8 years in chemical development experience including hands-on manufacturing expertise (particularly small molecule)</li> <li>Experience throughout the development/commercial continuum preferred, including technology transfer, scale up, process validation and commercial manufacturing</li> <li>Detailed knowledge of ICH, FDA, EMA regulations focused on CMC development</li> <li>Global CMC requirements knowledge is desirable</li> <li>Experience overseeing external development and manufacturing vendors</li> <li>Comfort working in a dynamic, fast-paced environment, interacting with internal and external teams and flexibility in supporting clinical and commercial development and manufacturing needs</li> <li>Expertise with DoE, risk assessments and FMEAs is preferred.</li> <li>Experience in the preparation of CMC sections for regulatory filings preferred</li> <li>Excellent communication (written and oral) and organizational skills</li> <li>Excellent skills required in Microsoft Word, Excel, Project and Adobe Acrobat</li> </ul> <p><strong>PERSONAL ATTRIBUTES</strong></p> <ul> <li>Demonstrated alignment with Roivant values and culture</li> <li>Attention to detail, focus on goals, and ability to work in a cross-functional team</li> <li>Ability to travel up to 20-30% of time</li> </ul> <p>#LI-JM1</p> Jun 28th, 2018 10:22PM Jun 28th, 2018 10:22PM
8 nasdaq:axon www.axovant.com www.axovant.com Jun 28th, 2018 12:00AM Manager, Process Development Open CMC New York, NY New York NY USA Jun 27th, 2018 12:00AM <p><strong>JOB SUMMARY</strong></p> <p>The Roivant Sciences, Inc. Pharmaceutical Development and Manufacturing organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs - both NCEs and biopharmaceuticals - and drug products – solid and parenteral dosage forms.  A significant component of these development activities are the synthetic methods required to develop and register these critical medicines.  The development and manufacturing activities are conducted through CMOs, where appropriate synthetic processes are required to control the quality of raw materials, intermediates and final products.  The ideal candidate is expected to support synthetic development of small molecule candidates from Phase I through NDA.</p> <p>The Manager, Process Development, will be responsible for CMC technical activities with drug substance, as well as synthetic activities conducted at CMOs for process development, optimization, CPP identification, QbD/DOE, technology transfer, manufacturing and validation.  In some instances, the individual will need to work with CMOs to innovate new synthetic routes and reactions where needed.  Specifically, the candidate will demonstrate a proven track record of managing CMOs to develop manufacturing routes and processes and quality control strategies to support Phase I to commercial launch.  Experience with IND filing and NDA submissions desired.</p> <p><strong>RESPONSIBILITIES</strong></p> <ul> <li>Execute CMC regulatory strategy for Drug Substance, including:</li> <ul> <li>Authoring, Requests for Proposals and leading the CDMO selection process</li> <li>Leading technology transfer activities, process development, scale up and oversight of manufacturing activities at the CDMO</li> <li>Collaborating with Quality Assurance to ensure all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.</li> <li>Supporting batch record review, investigations, deviations and change controls as needed.</li> </ul> <li>Liaise with cross-functional teams (QA, Regulatory, as well as other CMC functions, Clinical and Toxicology) to ensure consistency of methods, specifications and manufacturing control during Drug Substance scale-up.  Work with cross- functional teams to assure the quality of final Drug Substance used for non-clinical and clinical studies, registration and validation activities</li> <li>Support phase-appropriate control using appropriate process development strategies; manage product stability and reference standard programs; ensure that all methods for starting materials, intermediates, in-process controls, and final drug substance are adequate for the control of process-related impurities</li> <li>Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression; serve as the CMC representative in cross-functional project teams</li> <li>Author and/or review development and validation reports and API sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA, BLA submissions, briefing books, DMF, and other regulatory submission documents and updates</li> <li>Assist in troubleshooting drug substance manufacturing processes when required</li> <li>Ensure proper communication and reporting to the CMC organization, CMC leads, and other functions</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>BS/MS in Synthetic Chemistry or equivalent, with a minimum of 8 years in chemical development experience including hands-on manufacturing expertise (particularly small molecule)</li> <li>Experience throughout the development/commercial continuum preferred, including technology transfer, scale up, process validation and commercial manufacturing</li> <li>Detailed knowledge of ICH, FDA, EMA regulations focused on CMC development</li> <li>Global CMC requirements knowledge is desirable</li> <li>Experience overseeing external development and manufacturing vendors</li> <li>Comfort working in a dynamic, fast-paced environment, interacting with internal and external teams and flexibility in supporting clinical and commercial development and manufacturing needs</li> <li>Expertise with DoE, risk assessments and FMEAs is preferred.</li> <li>Experience in the preparation of CMC sections for regulatory filings preferred</li> <li>Excellent communication (written and oral) and organizational skills</li> <li>Excellent skills required in Microsoft Word, Excel, Project and Adobe Acrobat</li> </ul> <p><strong>PERSONAL ATTRIBUTES</strong></p> <ul> <li>Demonstrated alignment with Roivant values and culture</li> <li>Attention to detail, focus on goals, and ability to work in a cross-functional team</li> <li>Ability to travel up to 20-30% of time</li> </ul> <p>#LI-JM1</p> Jun 27th, 2018 10:29PM Jun 27th, 2018 10:29PM
9 nasdaq:axon www.axovant.com www.axovant.com Jul 12th, 2018 12:00AM Manager, FP&A Open Accounting New York, NY New York NY USA May 31st, 2018 12:00AM <p><strong>JOB SUMMARY:</strong></p> <p>FP&amp;A enables efficient utilization of resources through forecasting, actual vs. budget reporting, and financial analytics.  The Manager of Financial Planning &amp; Analysis, will be responsible for ownership of key financial reporting processes and initiatives.  The successful candidate will serve as a go-to business partner for functional leadership.</p> <p><strong>REQUIREMENTS:</strong></p> <ul> <li>Partner with a fast-growing business to develop forecasts and budgets for P&amp;L, BS, CF, plus key operational metrics (e.g. headcount, trial enrollment, etc) to support the rapidly growing business needs.</li> <li>Develop and deliver monthly/quarterly internal reporting of financial and operational actuals and conduct in-depth budget vs. actual analytics.</li> <li>Partner with Accounting and Accounts Payable teams to ensure data accuracy and consistency, and reasonability with the rapidly evolving business.</li> <li>Identify and drive continuous improvement efforts for processes, procedures, financial infrastructure, and expense categorization consistent with the business requirements.</li> </ul> <p><strong>QUALIFICATIONS:</strong></p> <p>Education:<strong>  </strong></p> <ul> <li>BS in relevant discipline required</li> <li>MBA or CPA preferred. Technical degree a plus.</li> </ul> <p>Experience (e.g. Jobs, supervisory, industry, international, etc…): </p> <ul> <li>Pharmaceutical and biopharmaceutical experience preferred</li> <li>7+ years of relevant experience in financial analysis, financial management.</li> </ul> <p>Specialized knowledge, Licenses, etc.: </p> <ul> <li>CFA, CPA and other accounting certificates preferred</li> <li>Proficient with financial management reporting systems (e.g. Hyperion, TM1, SAP etc.)</li> <li>Highly proficiency in Excel, Word, PowerPoint and proficient in other Office programs</li> </ul> <p>Other skills/attributes:</p> <ul> <li>Strong communication skills - written and verbal</li> <li>Demonstrated alignment with Axovant values and culture</li> </ul> <p> </p> Jul 11th, 2018 10:26PM Jul 11th, 2018 10:26PM
10 nasdaq:axon www.axovant.com www.axovant.com Jul 11th, 2018 12:00AM Manager, FP&A Open Accounting New York, NY New York NY USA May 31st, 2018 12:00AM <p><strong>JOB SUMMARY:</strong></p> <p>FP&amp;A enables efficient utilization of resources through forecasting, actual vs. budget reporting, and financial analytics.  The Manager of Financial Planning &amp; Analysis, will be responsible for ownership of key financial reporting processes and initiatives.  The successful candidate will serve as a go-to business partner for functional leadership.</p> <p><strong>REQUIREMENTS:</strong></p> <ul> <li>Partner with a fast-growing business to develop forecasts and budgets for P&amp;L, BS, CF, plus key operational metrics (e.g. headcount, trial enrollment, etc) to support the rapidly growing business needs.</li> <li>Develop and deliver monthly/quarterly internal reporting of financial and operational actuals and conduct in-depth budget vs. actual analytics.</li> <li>Partner with Accounting and Accounts Payable teams to ensure data accuracy and consistency, and reasonability with the rapidly evolving business.</li> <li>Identify and drive continuous improvement efforts for processes, procedures, financial infrastructure, and expense categorization consistent with the business requirements.</li> </ul> <p><strong>QUALIFICATIONS:</strong></p> <p>Education:<strong>  </strong></p> <ul> <li>BS in relevant discipline required</li> <li>MBA or CPA preferred. Technical degree a plus.</li> </ul> <p>Experience (e.g. Jobs, supervisory, industry, international, etc…): </p> <ul> <li>Pharmaceutical and biopharmaceutical experience preferred</li> <li>7+ years of relevant experience in financial analysis, financial management.</li> </ul> <p>Specialized knowledge, Licenses, etc.: </p> <ul> <li>CFA, CPA and other accounting certificates preferred</li> <li>Proficient with financial management reporting systems (e.g. Hyperion, TM1, SAP etc.)</li> <li>Highly proficiency in Excel, Word, PowerPoint and proficient in other Office programs</li> </ul> <p>Other skills/attributes:</p> <ul> <li>Strong communication skills - written and verbal</li> <li>Demonstrated alignment with Axovant values and culture</li> </ul> <p> </p> Jul 10th, 2018 10:31PM Jul 10th, 2018 10:31PM

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