Associate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics
Merck
4 months ago
Remote friendly (North Wales, PA)
United States
Corporate Functions
Associate Principal Scientist, Regulatory CMC - Biologics (R4)
Responsibilities:
- Implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in accordance with domestic and international regulations and guidance.
- Prepare and submit CMC sections for commercial or new biologics products.
- Assist in developing and implementing internal regulatory strategies.
- Provide mentoring and coaching to Sr. Scientist / Scientist.
- Participate in the authorization process to prioritize submissions.
- Complete detailed, global regulatory assessments according to existing guidelines/policies and defined timelines.
- Develop and execute global regulatory strategies for INDs, BLAs, and post-approval change documentation.
- Plan, track, and communicate submissions and approvals to support continued product supply.
- Lead authoring of IND/CTAs, BLAs, and global post-approval submissions.
- Collaborate with partner groups to ensure submissions are compliant, accurate, and complete.
- Resolve project issues through team collaboration and escalation to CMC leadership as appropriate.
- Participate in early/late development programs and cross-functional efforts to improve CMC content or processes (as needed).
Education (Minimum Requirement):
- B.S. in science, engineering, or related field (advanced degree preferred), including Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
Required Experience and Skills:
- At least 10 years subject matter expertise in biologics CMC development or manufacturing; prior Biologics IND, BLA, and/or post-approval filing experience.
- Biologics regulatory CMC experience in pre-approval and registration, including authoring agency interactions, responses to questions, and IND/IMPD and BLA sections.
- Sound understanding of related areas (e.g., manufacturing, process development, analytical, quality assurance) and ability to solve new/diverse problems.
- Proven ability to critically review scientific information and evaluate whether arguments and conclusions are supported by data.
- Superior oral and written communication skills in multicultural settings.
- Flexibility with changing priorities and unexpected events.
- Effective leadership, project management, communication, interpersonal, and negotiating skills.
- Ability to generate innovative solutions to complex regulatory problems and work/communicate with key stakeholders.
Preferred Experience and Skills:
- Experience with ADCs through to commercialization.
- Preferred fields: Microbiology, Virology, Molecular Biology, Engineering, or Biochemistry.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Compensation/Benefits (if applicable in posting):
- Eligible for annual bonus and long-term incentive, if applicable.
- Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Responsibilities:
- Implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in accordance with domestic and international regulations and guidance.
- Prepare and submit CMC sections for commercial or new biologics products.
- Assist in developing and implementing internal regulatory strategies.
- Provide mentoring and coaching to Sr. Scientist / Scientist.
- Participate in the authorization process to prioritize submissions.
- Complete detailed, global regulatory assessments according to existing guidelines/policies and defined timelines.
- Develop and execute global regulatory strategies for INDs, BLAs, and post-approval change documentation.
- Plan, track, and communicate submissions and approvals to support continued product supply.
- Lead authoring of IND/CTAs, BLAs, and global post-approval submissions.
- Collaborate with partner groups to ensure submissions are compliant, accurate, and complete.
- Resolve project issues through team collaboration and escalation to CMC leadership as appropriate.
- Participate in early/late development programs and cross-functional efforts to improve CMC content or processes (as needed).
Education (Minimum Requirement):
- B.S. in science, engineering, or related field (advanced degree preferred), including Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
Required Experience and Skills:
- At least 10 years subject matter expertise in biologics CMC development or manufacturing; prior Biologics IND, BLA, and/or post-approval filing experience.
- Biologics regulatory CMC experience in pre-approval and registration, including authoring agency interactions, responses to questions, and IND/IMPD and BLA sections.
- Sound understanding of related areas (e.g., manufacturing, process development, analytical, quality assurance) and ability to solve new/diverse problems.
- Proven ability to critically review scientific information and evaluate whether arguments and conclusions are supported by data.
- Superior oral and written communication skills in multicultural settings.
- Flexibility with changing priorities and unexpected events.
- Effective leadership, project management, communication, interpersonal, and negotiating skills.
- Ability to generate innovative solutions to complex regulatory problems and work/communicate with key stakeholders.
Preferred Experience and Skills:
- Experience with ADCs through to commercialization.
- Preferred fields: Microbiology, Virology, Molecular Biology, Engineering, or Biochemistry.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Compensation/Benefits (if applicable in posting):
- Eligible for annual bonus and long-term incentive, if applicable.
- Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.