Manager, Quality Control, Microbiology
Manager: Senior Director, Quality Control
Department: Technical Operations
Location: Brisbane, CA 94005 or Remote
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let’s build a better future together.
Sangamo Therapeutics is seeking a Manager, Quality Control who will manage a team responsible for all cGMP Microbiology testing including environmental monitoring. The position will be a key member of the Quality Control Management Team and will be responsible for implementation and continuous improvement of all processes/systems in support of the Microbiology, Environmental Monitoring and Aseptic Gowning Programs for the Manufacturing Plant. The position will support GMP 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 management of the Company’s designated Contract Testing Organizations (CTOs).
- Manages and provides expert knowledge in the day-to-day function of the Microbiology group
- Develop and oversee the contamination control program, ensuring utilities and facilities conform to company standards and to regulatory requirements.
- Oversees environmental action level reports and investigations and trend reports and tracking the effectiveness of preventive actions.
- 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.
- Oversees contract lab testing activities.
- Coordinates testing including validation and qualification, and the dissemination of the results of those activities to the relevant customers.
- Responsible for meeting deadlines under a tight timeline and changing priorities.
- Support site external supplier audits as SME.
- Facilitate of QC project meetings and functional sub-team by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines
- Work with QC management and project team lead to identify and mitigate risks to meeting QC milestones and goals.
- Ensures assigned projects are conducted in compliance with applicable Tech Ops procedures
- Write and revise standard operating procedures as needed.
- Oversee QC activities at CTOs, including the review of test records/forms, final reports, Standard Operating Procedures (SOPs) and COAs
- Review of SOPs, records/forms and protocols for in-house QC testing and overall QC operations
- Assist in the preparation of CMC regulatory submissions
- Support other QC activities and projects as needed
- 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 Microbiology or related discipline.
- Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
- 5+ years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility with strong knowledge of regulatory, USP and Eur. Phr guidelines as related to Microbiology issues, environmental monitoring, aseptic processing, and biosafety.
- 3-5+ years’ experience managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry.
- Strong data integrity knowledge and practices.
- Strong knowledge of contamination control, disinfection, cleanroom design and operation, and aseptic techniques.
- Experience starting up lab facilities supporting clinical and/or commercial manufacturing.
- Proficient in MS Word, Excel, Power Point and other applications.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
- Solid communication and presentation skills required.
- Experience of managing CMO/CTO relationships and projects
- Sound understanding and demonstrated application of statistical methods/tools
- Excellent interpersonal skills, outstanding organizational skills, and excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part.
If you wish to be considered for the presentation of candidates, please contact us through Recruiting@sangamo.com. Attach your contact information, your area of specialty, and any marketing information you wish to provide. Someone from the Talent Acquisition Department will contact you directly if there is a business need for your services.