MSD

Associate Principal Scientist – Regulatory Affairs, CMC, Biologics

MSD

full-time

Posted on:

Location Type: Hybrid

Location: North Wales • Massachusetts • New Jersey • United States

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Salary

💰 $142,400 - $224,100 per year

Job Level

Senior

About the role

  • Responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies
  • Preparation and submission of CMC sections for commercial or new biologics products
  • Assist in the development and implementation of internal regulatory strategies
  • Mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects
  • Lead authoring of clear, concise and effective IND / CTAs, BLAs or global post approval submissions
  • Collaborate with partner groups to ensure compliance, scientific excellence, accuracy and completeness of submissions

Requirements

  • B.S. in a science, engineering, or a related field (advanced degree preferred)
  • 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)
  • Demonstrated superior oral and written communication skills in multicultural settings
  • Demonstrated ability to generate innovative solutions to complex regulatory problems
Benefits
  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays, vacation, and compassionate and sick days
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC regulatory strategiesIND authoringCTA authoringBLA authoringpost approval submissionsbiologics CMC developmentbiologics manufacturingagency interactionsregulatory complianceanalytical methods
Soft Skills
mentoringcoachingcommunication skillscollaborationproblem-solvinginnovationleadershipmulticultural communicationproject managementteamwork
Certifications
B.S. in scienceB.S. in engineeringadvanced degree in related field