CMC Quality Control Writer / Reviewer

A California-based biopharmaceutical company is looking to add an experienced professional to their CMC Quality Control Department as a Writer / Reviewer. In this role, the CMC Quality Control Writer / Reviewer will be responsible for authoring, drafting. reviewing, and approving the Regulatory QC CMC sections of the company's IND/IMPD and BLA/NDA filings for one or more the company's programs.

***This is a Hybrid opportunity requiring 2 days onsite in Brisbane, CA and 3 days remote work

Responsibilities:

The CMC Quality Control Writer / Reviewer

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

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

Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines

Perform other duties, as needed

Qualifications:

5+ years of Analytical / Quality Control experience in a GMP environment

Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field

Previous experience in the Biotech and/or Pharmaceutical industry

Good understanding of cGMPs, ICH and Regulatory Drug requirements

Proficient in Project and Personnel Management

Microsoft Office proficient (Excel, Word, etc.)

Great interpersonal skills

Excellent communication skills (written and verbal)

Strong attention to detail

Highly organized

Desired Skills:

Experience with writing and reviewing of CMC filings for regulatory submissions, including IND/IMPD, BLA, and/or MAA

Proficient in Statistical Analysis software (Excel/JMP)