Associate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, B

Job Title

Associate Principal Scientist, Regulatory CMC – Biologics (R4)

Equivalent to an Associate Director position.

Job Description

This Associate Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for the organization’s biologics product franchises in accordance with domestic and international regulations and guidance. The role includes preparation and submission of CMC sections for commercial or new biologics products, development of internal regulatory strategies, and mentoring of senior scientists.

Key Responsibilities

• Participation in the authorization process to prioritize submissions.
• In-depth knowledge of global CMC guidelines for IND/BLAs or post‑approval changes.
• Completion of detailed, global regulatory assessments according to existing guidelines and policies within defined timelines.
• Development and execution of detailed, global regulatory strategies for submission and approval of INDs, BLAs or post‑approval change documentation.
• Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
• Lead authoring of clear, concise and effective IND/CTA, BLA or global post‑approval submissions within defined timelines.
• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
• Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
• Participation in early and late development programs, as well as departmental and cross‑functional efforts to improve CMC content or processes.

Education – Minimum Requirements

• B.S. in a science, engineering, or related field (advanced degree preferred). Fields include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.

Required Experience and Skills

• At least 10 years of subject matter expertise in biologics CMC development or manufacturing, including Biologics IND, BLA and/or post‑approval filing experience.
• Experience in biologics regulatory CMC in both pre‑approval and registration, with agency interactions, responses to questions, and IND/IMPD and BLA sections.
• Sound understanding of related fields (manufacturing, process development, analytical, quality assurance) and ability to creatively solve diverse problems.
• Experience critically reviewing detailed scientific information, assessing technical arguments, and ensuring conclusions are supported by data.
• Superior oral and written communication skills in multicultural settings.
• Flexibility in responding to changing priorities or unexpected events.
• Effective leadership, project management, communication, interpersonal and negotiating skills.
• Ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders.

Preferred Experience and Skills

• Experience with ADCs through to commercialization.
• Preferred fields of study include Microbiology, Virology, Molecular Biology, Engineering or Biochemistry.

Salary Range

$142,400.00 – $224,100.00

Benefits

Medical, dental, vision, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.

EEO Statement

Merck is an Equal Employment Opportunity Employer. We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or any other applicable legally protected characteristics.

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