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

Overview

Associate Principal Scientist, Regulatory CMC - Biologics (R4) — This position is equivalent to an Associate Director position.

Under direction from Director/Executive Director, the Assoc Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our biologics product franchises in accordance with domestic and international regulations and guidance. The Assoc Principal Scientist prepares and submits CMC sections for commercial or new biologics products. The role will assist in developing and implementing internal regulatory strategies and provide mentoring to Sr. Scientist/Scientist on assigned projects.

Responsibilities

• Participation in the authorization process to prioritize submissions.
• In-depth knowledge of global CMC guidelines regarding IND/BLAs or post-approval changes.
• Completion of detailed, global regulatory assessments according to guidelines and defined timelines.
• Development and execution of global regulatory strategies for submission and approval of INDs, BLAs, or post-approval change documentation according to defined timelines.
• Careful planning, tracking, and communication regarding submissions and approvals to support continued product supply.
• Lead authoring of clear, concise IND/CTAs, BLAs, or global post-approval submissions according to 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 and escalation to the CMC leadership team as appropriate.
• Participation in early and late development programs, and cross-functional efforts to improve CMC content or processes as needed.

Education Minimum Requirement

• 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, with prior biologics IND, BLA, and/or post-approval filing experience.
• Experience in biologics regulatory CMC in pre-approval and registration, with authoring agency interactions, responses to questions, and IND/IMPD and BLA sections.
• Understanding of related fields (manufacturing, process development, analytical, quality assurance) and ability to implement creative problem solving.
• Proven ability to critically review detailed scientific information and present data-supported conclusions clearly.
• Excellent oral and written communication skills in multicultural settings and ability to convey complex issues succinctly.
• Flexibility in adapting to changing priorities or unexpected events.
• Demonstrated leadership, project management, communication, interpersonal, and negotiating skills.
• Ability to generate innovative regulatory solutions and communicate 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.

Required Skills

• Accountability
• Adaptability
• Biochemistry
• Biological Sciences
• BLA regulatory knowledge
• Regulatory CMC
• Manufacturing
• Microbiology
• Molecular Biology
• eCTD
• Cross-Cultural Awareness
• Detail-Oriented
• Documentation

Hybrid Work Model and Location

• Hybrid work model: three on-site days per week, Friday remote, subject to site requirements.
• Travel requirements: 10%.
• Relocation: No relocation.
• VISA Sponsorship: No.

Compensation and Benefits

Salary range: $142,400.00 - $224,100.00. The candidate may be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement (401(k)), holidays, vacation, and sick days.

Application and Notices

You can apply for this role through the company careers page. The application deadline for this position is stated on the posting.

Legal and Equal Opportunity

We are an Equal Employment Opportunity Employer. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information, see EEOC resources. We encourage diverse and inclusive collaboration.

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