Manager - Downstream Protein Purification
Oakland-Fremont-Pleasanton Metro Area, CA
- Manufacturing Organization supports Technical Operations (TechOps) by compliantly & successfully producing antigen-based products in line with commercial cGMPs.
- Downstream Manager-MS&T will lead a team of specialists in the areas of process development, technology transfer & technical support for downstream Manufacturing operations.
- Successful candidate will have primary oversight for protein purification laboratory/pilot plant function where suitable scale-down models will be defined & qualified as appropriate in support of process development, scale up & technology transfer, process troubleshooting during routine manufacture & process characterization/robustness studies in support of commercialization activities.
- Considerable knowledge in area of protein purification.
- Leads process development, technical support, process monitoring & optimization/improvement activities for manufacturing & analytical testing
- Supports process technology transfer & scale-up to commercial facilities
- Individual will be accountable for resource allocation & utilization, project scheduling & prioritization & scientific data review including data integrity verification, statistical analysis & technical report writing.
- Integrates knowledge & experience in science to think & act strategically within their functional area
- Manages people (including staffing, delegation, managing & measuring work) & manages performance (including motivating & developing strong performers & effectively confronting & resolving performance issues)
- Active participation in health authority audits (FDA, EMEA) & review of regulatory submissions
- Author Product Impact Assessments (PIAs) & Risk Assessments to assist QA in the determination of the releasability of product lots as required
- Drive & review Change Controls for the implementation of Purification process changes into Manufacturing
- Work with QA to identify & implement appropriate CAPAs from the root causes of investigations to prevent their re-occurrence
- Technical/scientific knowledge of biopharmaceutical processes, at both process development & manufacturing scales of operation
- Knowledge of process scale-up & scale-down methodologies, including process characterization design of experiments
- Experience in process technology transfer within & between organizations, manufacturing support & troubleshooting
- Writes procedures & technical reports that include data interpretation.
- Extensive working knowledge of cGMP environments
- Skilled in application of standardized root cause analysis, investigation tools & methodologies.
- Proficient with the use of MS Office software(Excel, Word, PowerPoint) & application software including Unicorn, JMP, Minitab, Design Expert, etc.)
- Direct expertise with Lean, 5S, Operational Excellence
- Lead a team of 10-15 scientists & specialists (BS to PhD level)
- Be a change agent, promoting flexible & open mindsets to new opportunities.
- Support direct/indirect staff member development through coaching & mentoring, timely & candid feedback, helping craft meaningful individual development plans & tailoring individual goals
- Educational degrees relevant to position (e.g., Biology, Biochemistry, Chemistry or Toxicology)
- Minimum of 8+ yrs. of GMP experience including 4+ yrs. of supervisory or team leadership experience.
- MS + 10 yrs.; PhD + 8 yrs. Or BA/BS degree in chemistry, biology, engineering or related field with 12 yrs. of related experience.