Germer International - Pharmaceutical Recruiting
Director of Process Development Engineering
Germer International - Pharmaceutical Recruiting, Boston, Massachusetts, us, 02298
Director of Process Development Engineering
Germer International - Pharmaceutical Recruiting provided pay range. This range is provided by Germer International - Pharmaceutical Recruiting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Compensation Base pay range: $210,000.00/yr - $240,000.00/yr. Additional compensation: Annual Bonus and RSUs.
Overview This position is responsible for leading and empowering the Development Team in taking Company’s drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.
Responsibilities
Lead process development strategy for Company’s products and ensure processes are suitable for the phase of development and ultimately for commercial manufacturing, including process design and development, scale-up and optimization, characterization and control strategy development, and technical transfer to internal manufacturing site or CMOs/CDMOs.
Recruit, manage, train, motivate, develop, and mentor Process Development staff.
Collaborate with colleagues across Pharmaceutical Development and Manufacturing to leverage internal and external capabilities for process development.
Ensure process development approaches are suitable for progressive stages of small molecule pharmaceutical development in line with ICH and FDA guidance.
Operate the Process Development laboratories and GMP clinical manufacturing suites (under development in Waltham, MA).
Provide subject matter expertise in process development methodologies, including internal execution and technical oversight/supervision.
Present technical data to cross-functional teams and senior management, communicating critical process issues and solutions.
Guide and drive process development, design of experiments, product characterization and control strategy development.
Develop, review, and approve process development source documents; author and review drug product process development sections for regulatory submissions.
Keep the team updated on current technologies and manufacturing trends, focusing on continuous improvement and operational excellence.
Manage the team budget and support planning of capital requirements for the future.
Support Regulatory in responding to agency questions; support process validation and commercial launch; provide technical support to internal sites and CMOs.
Qualifications
PhD or MS in Science or Engineering.
15+ years of technical and leadership experience in pharmaceutical development, including Process Development, scale-up, and GMP manufacturing with a track record of developing and commercializing products and processes.
Expertise in small molecule (primarily oral solid dose) process development, scale-up, control strategy development, and technical transfer.
Seniority
Director
Employment type
Full-time
Job function
Science
Industries
Pharmaceutical Manufacturing
Inferred from the description for this job: Medical insurance, Vision insurance, 401(k), Paid maternity leave, Paid paternity leave.
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Compensation Base pay range: $210,000.00/yr - $240,000.00/yr. Additional compensation: Annual Bonus and RSUs.
Overview This position is responsible for leading and empowering the Development Team in taking Company’s drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.
Responsibilities
Lead process development strategy for Company’s products and ensure processes are suitable for the phase of development and ultimately for commercial manufacturing, including process design and development, scale-up and optimization, characterization and control strategy development, and technical transfer to internal manufacturing site or CMOs/CDMOs.
Recruit, manage, train, motivate, develop, and mentor Process Development staff.
Collaborate with colleagues across Pharmaceutical Development and Manufacturing to leverage internal and external capabilities for process development.
Ensure process development approaches are suitable for progressive stages of small molecule pharmaceutical development in line with ICH and FDA guidance.
Operate the Process Development laboratories and GMP clinical manufacturing suites (under development in Waltham, MA).
Provide subject matter expertise in process development methodologies, including internal execution and technical oversight/supervision.
Present technical data to cross-functional teams and senior management, communicating critical process issues and solutions.
Guide and drive process development, design of experiments, product characterization and control strategy development.
Develop, review, and approve process development source documents; author and review drug product process development sections for regulatory submissions.
Keep the team updated on current technologies and manufacturing trends, focusing on continuous improvement and operational excellence.
Manage the team budget and support planning of capital requirements for the future.
Support Regulatory in responding to agency questions; support process validation and commercial launch; provide technical support to internal sites and CMOs.
Qualifications
PhD or MS in Science or Engineering.
15+ years of technical and leadership experience in pharmaceutical development, including Process Development, scale-up, and GMP manufacturing with a track record of developing and commercializing products and processes.
Expertise in small molecule (primarily oral solid dose) process development, scale-up, control strategy development, and technical transfer.
Seniority
Director
Employment type
Full-time
Job function
Science
Industries
Pharmaceutical Manufacturing
Inferred from the description for this job: Medical insurance, Vision insurance, 401(k), Paid maternity leave, Paid paternity leave.
Get notified when a new job is posted. Sign in to set job alerts for “Director Process Development” roles.
#J-18808-Ljbffr