Supervisor, Analytical Development
San Diego, CA
PaxVax is seeking a talented and motivated individual with experience in assay development and quality control testing in a cGMP manufacturing environment. This position will be responsible for the evaluation, development, optimization, qualification and validation of cell based assays such as TCID50, Western Blot and PCR. This position also requires conducting routine analysis of materials and processes required for the formulation, release, and stability of API and finished drug product. In addition, this position may perform routine QC assays such as Karl Fischer and Disintegration.
This position is responsible for scheduling of all testing, as relates to the Analytical Development /QC laboratory, ensuring that testing timelines are met. This position is liaison between QC and other supporting CMC department heads. This position aids in investigations (OOS and OOT), recommends CAPAs and provides key compliance insight and support. The personal provides direction in interpreting procedures, test methods, and analytical results and assists in the development and training of staff. In addition, the Supervisor/Manager provides technical oversight and compliance guidance for analytical methods and procedures.
- Work within a small, dynamic, and fast-paced cross-functional project team
- Responsible for the development, qualification and validation of cell based assays
- Responsible for performing or coordinating method transfers
- Oversight of analytical testing to ensure the timely release of raw materials, buffers, intermediates, drug substance, final products and stability samples.
- Provide support for the qualification and validation of analytical instruments
- Identify and resolve discrepancies, OOS, and deviations
- Author and revise SOPs, validation protocols, and validation reports.
- Scheduling of all stability and release testing.
- Evaluate trend data and author trend reports to proactively identify issues for compliance to procedures and specifications
- Oversight of assay performance through data trending and metrics.
- Maintain procedures for accuracy and compliance.
APPLY FOR THIS JOB
- Experience with cGMPs in accordance to FDA specifications
- Knowledge of and hands on experience with cell based assays
- Possess a strong work ethic along with a solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills
- Demonstrated experience working independently, quickly
- Experience working in a dynamic multidisciplinary environment with quickly changing priorities.
- Experience managing scientific projects, personnel and presenting technical data.
- Knowledge of cGMP, ICH, USP and global compendia regulations and guidance documents, with an emphasis on analytical and bioanalytical method execution, development, and validation.
- Experience with scientific technical writing including authoring and revising SOPs or technical reports
- Bachelor’s Degree in Biology, Chemistry or similar discipline and 10 years of experience or Master’s degree and 7 years of experience