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

Associate Principal Scientist, Regulatory CMC – Biologics (R4)

This Associate Principal Scientist position is equivalent to an Associate Director position.

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 existing global guidelines and policies and defined timelines.
• Development and execution of detailed, global regulatory strategies for submission and approval of INDs, BLAs or post‑approval change documentation according to defined timelines.
• Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
• Lead authoring of clear, concise and effective 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 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 may also be required, as needed.

Education Minimum Requirement

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

Required Experience And Skills

• Prior Biologics IND, License Application (BLA) and/or post‑approval filing experience with at least 10 years subject matter expertise in biologics CMC development or manufacturing.
• Experience in biologics regulatory CMC in both pre‑approval and registration required, with experience authoring agency interactions, responses to questions, and IND/IMPD and BLA sections.
• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

Preferred Experience And Skills

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

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements (EEO Statement)

As 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 other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement, and learn more about your rights, including under California, Colorado and other U.S. State Acts.

Salary

$142,400.00 – $224,100.00 (based on education, qualifications, experience, geographic location and other factors)

Benefits

We offer a comprehensive package of benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

Application

Apply through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

#J-18808-Ljbffr