CONTRACT – GMP QC OPERATIONS MANAGER
Position Summary:
The GMP QC Operations Manager supports the analytical department for the BLA development program of a monoclonal antibody. Contributions to include Drug Substance and Drug Product stability program management as well as ownership of reference standard requalification and make/assess/release activities of a working reference standard. Technical review and remediation of BLA enabling process characterization and method qualification/validation activities. The candidate will be responsible for timely initiating, maintaining and driving to closure all CMC related GMP documentations as required by SOPs and regulatory guidance. The candidate will also be responsible to review and verify process and CMC analytical data from CMOs for critical GMP/regulatory documents. The candidate will also provide support to organize and archive the completed internal and external CMC documents. The candidate may perform other duties to support biologics CMC development and operations as appropriate.
Essential Duties and Responsibilities:
- Mange Stability Program for DS, DP, and Reference Standard by reviewing and assessing stability data from CMOs and authoring Stability Reports
- Map and own sample shipment logistics for process characterization and validation
- Support project management activities for validation of analytical methods at CMOs for drug substance and drug product manufacturing
- Initiate Drug Substance and Drug Product analytical related deviations, Change Control and CAPAs per SOP and drive the assessment process with internal state holders to ensure the appropriate on-time closure
- Perform data review and the investigation of the analytical testing/validation issues
- Provide expert guidance on the large molecule analytical development, validation and establishment of specifications
- Support Quality, Regulatory Affairs in preparing CMC section in regulatory filings
- Review and assess reference standard data
Qualifications:
- A degree Biochemistry, Chemistry, Chemical engineering or related discipline. PhD with minimum 5 years of experience, MS with 10 years, BS with 15 years
- In-depth experience and knowledge in large molecule analytics
- Experience with reviewing analytical data for monoclonal antibody release testing and characterization (SEC, CGE, cIEF, potency, LCMS, wet chemistry methods, etc.)
- Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and comparability assessment
- Experience in recombinant protein submissions
- Must have excellent problem-solving skills and verbal and written communication skills
- Requires working knowledge of IND/BLA submissions, Quality and regulatory requirements
- Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
- Comfortable executing on multiple projects independently