CMC Quality Control Manager

2 weeks ago

Reston, Virginia, United States Planet Pharma Full time
Job Title: CMC Quality Control Manager

We are seeking a highly motivated and experienced professional as CMC Quality Control Manager for our Quality Control department, with the passion and creativity to support development of great medicines for rare and ultra-rare diseases.

Job Summary:

The CMC Quality Control Manager will be responsible for all aspects of QC data review for commercial and clinical programs, including all modalities, and all molecules. The Manager will work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality standards are met to support the programs.

Key Responsibilities:
  • Author, draft, review, and approve the Regulatory QC CMC sections of our IND/IMPD and BLA/NDA filings for one or more programs
  • Author, update, and revise CMC stability sections in support of regulatory filings
  • Address CMC stability inquiries per regulatory inquiries
  • Perform review/draft of analytical release and stability data, data integrity, laboratory documentation, stability reports, specifications, specification setting reports, and other QC/analytical documents
  • Participate in the qualification/validation of analytical test methods for all Product Quality parameters, specification setting, stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines
  • Generate QC documents including, but not limited to, CoAs, reference standard qualifications and reports and risk assessments
  • Work within QC and with QA and other departments to address review comments on regulatory and QC/analytical documents
  • Manage/assist the document creations and reviews via Veeva Document System
  • Create and update batch analysis tables for release data
  • Create Excel/JMP tables and graphs/charts for release and stability data trending
  • Initiate and manage change controls, deviations and CAPA with Veeva Document System
  • Assist in closing Quality events/Deviations (OOS/OOT/OOE) and Deviation investigations
Requirements:
  • Bachelor's degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
  • Experience with writing and reviewing of CMC filings for regulatory submissions, including IND/IMPD, BLA, and/or MAA, is highly desirable
  • Senior Quality Manager: 5 plus years' experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
  • Working experience and knowledge in a wide variety of quality control release and stability methodologies is highly desirable
  • Good oral and written communication skills and a fast learner
  • Proficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlines
  • Proficiency in MS Office, Word, and Excel
  • Proficient in statistical analysis software desired (Excel/JMP)
About Us:

Planet Pharma is a biotech company focused on developing life-transforming therapeutics for patients with rare diseases. We are committed to creating innovative products that make a difference in people's lives.

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