Senior Manager, Quality Control Raw Materials
Manager: Vice President, Quality Control
Department: Quality Control
Location: Brisbane, CA
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. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today’s medicines can only treat symptoms. At Sangamo, we are passionate about transforming 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.
- 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.
- 8+ years' experience working in the cGMP laboratory.
- 3+ 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.
- 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
Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws
Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine & booster, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves.