Senior Manager, CMC QC

A biotechnology research organization located in Brisbane, CA is seeking a highly motivated and experienced Senior Manager for the Clinical and Commercial Programs in the Quality Control Department, with passion and creativity to support the development of great medicines. The Senior Manager will be responsible for all CMC QC Program support for the biological programs. The Senior Manager also will provide support to internal QC representatives who work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality and industrial standards are met to support of the quality control activities as assigned.

This position will be instrumental in supporting the company’s therapeutic products from development stage to commercial launch and be a critical part of an innovation team for the development of the company’s next generation products. The individual in this role is expected to carry out all quality control activities in a strictly regulated GMP environment (ICH/USP and Ph. Eur. Compendial/FDA and EMA).

Responsibilities including, but not limited to:

• Main focus: The Senior Manager of CMC QC will work across products/programs as assigned (Clinical & Commercial products on West Coast USA) for quality control operational support:
• Analytical Comparability: Experience with analytical method transfer, analytical comparability with a scientific understanding of quality attributes and their relationship to safety and quality
• QC Data Review: Review, organize, manage release / stability, and method validation/transfer data. Draft QC Data Review Summary Reports (DRSR)
• Content Verification: Confirm accuracy of transcribed data in regulatory filings, stability and development reports, and data summaries
• Quality Control Operational support: Provide internal support to QC operations to support the development, manufacture, method validation/transfer and release/stability activities, of products
• Assist with Stability Program management: Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines. Draft and review interim and final product stability reports
• Assist with Quality Systems: Implement and maintain quality systems to ensure the integrity and reliability of QC data

Other responsibilities may include:

• Work within QC, with QA, and other departments to address review comments on QC/analytical documents
• Manage/assist the document creations and reviews via Veeva Document System
• Create and update batch analysis tables for stability data
• Track contract lab stability time point pulls for different programs
• Create Excel/JMP tables and charts for stability data trending
• Assist in OOE/OOS/OOT investigations
• Ensure compliance with cGMP’s in a manufacturing environment such that the products are assessed via specifications and regulatory guidelines in a timely manner to support release and stability testing

Requirements:

• Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
• Five plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical and/or Biotech industries)
• Working experience and knowledge in a wide variety of quality control analytical methodologies is highly desirable
• 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

Preferred Skills:

• Experience in conducting stability studies per ICH guidelines is highly desirable.
• Excellent written and oral communication skills and a fast learner
• Proficient in statistical analysis software desired, JMP or others