Manager, Quality Control Raw Material in Brisbane, CA

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Industry:

Pharmaceuticals & Biotech   •  

5 - 7 years

Posted 7 weeks ago

JOB SUMMARY:

Sangamo Therapeutics is seeking a Manager, Quality Control Raw Material who will manage a growing team responsible for developing the raw materials strategy, harmonizing raw materials requirements and incoming testing approaches across external and internal manufacturing sites, and overseeing vendor material change notification. The role will interface with internal Quality Control, Manufacturing, and Quality Assurance groups to ensure company procedures and industry guidelines are followed. This position will support cGMP testing of the Company's products including recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and gene modified hematopoietic stem cells. This position will also support a wide variety of manufacturing process technical transfers as well as management of the Company's designated Contract Testing Organizations (CTOs).

ESSENTIAL FUNCTIONS:

  • Oversees QC Raw Material activities including the review of test records/forms, final reports, Standard Operating Procedures (SOPs) and COAs
  • Manages method qualification, protocol preparation, qualification execution, and report approval.
  • Manages deviation and out-of-specification reports and investigations and tracking the effectiveness of preventive action.
  • Interfaces with cross-functions teams service as SME for Raw Materials
  • Facilitates QC project meetings and functional sub-team meetings by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines
  • Works with QC management and project team lead to identify and mitigate risks to meeting QC milestones and goals.
  • Authors and Reviews QC SOPs, records/forms and CMC regulatory submissions
  • Empowers employees to take responsibility for their jobs and goals.
  • Coaches, mentors, engages and develops the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
  • Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
  • Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

  • Bachelor's degree or advanced degree in chemistry, biochemistry or related discipline.
  • Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
  • Depending on level, 5 - 8+ years' experience working in the cGMP laboratory.
  • Depending on level, 3 - 5+ years' experience managing analytical quality control laboratory.
  • Strong data integrity knowledge and practices.
  • Strong knowledge of USP, EP, JP monographs and USP/ICH/FDA/EU regulations.
  • Experience with statistical data analysis
  • Understanding of laboratory equipment such as UPLC/HPLC, UV/Vis, Spectrophotometer, Densitometer, pH, Osmometer, etc.
  • A passion for addressing the critical unmet medical needs of patients
  • Proficient in MS Word, Excel, Power Point and other applications.

OTHER QUALIFICATIONS:

  • Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
  • Solid collaboration, communication and presentation skills required.
  • Experience of managing CMO/CTO relationships and projects
  • Excellent interpersonal skills, outstanding organizational skills, and excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment