Manager: Associate Director, Quality Control Operations
Department: Technical Operations
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.
We are seeking a talented and highly motivated Senior Specialist to join our QC Operations team. The Senior Specialist will be tasked to oversee the QC sample management system in support of our internal and external cell and gene therapy manufacturing operations. Products to be supported include, but are not limited to, recombinant viral vectors (AAV and lentivirus), ex-vivo gene-modified T cells, and gene editing mRNAs. The QC Senior Specialist will be responsible for managing and tracking the receipt of QC samples from internal and external manufacturing teams, coordinating sample transfer to internal and external testing labs, managing retain and reserve sample inventories, and ensuring the proper disposal of samples following testing. Additionally, the Senior Specialist will oversee the QC material management program and will coordinate with GMP warehousing personnel to manage QC GMP reagent, receipt, use, and cycle times.
- Work with QC senior management to implement and oversee a compliant, inspection ready QC sample management program. Specific duties:
- Work with GMP-manufacturing personnel to ensure and document the timely and accurate receipt, storage, and distribution of all internally generated QC samples.
- Work with QC-external operations to ensure and document the accurate and timely receipt, storage and distribution of test samples generated by our external manufacturing partners.
- Work with each of the QC laboratory managers to coordinate the transfer and shipping (as necessary) of GMP test samples, reserve samples, and retain samples.
- Work with the QC data management team to develop and maintain an electronic inventory system for QC sample storage (reserve and retain samples) with the ultimate objective of developing and integrating a sample management module into the QC LIMS product lot management system.
- Work with QC and GMP warehouse management to establish the QC raw material program.
- Work with laboratory managers to ensure reagents and material stocks are maintained, and cycle times are tracked and managed.
- Build and manage a support team as internal manufacturing operations grow beyond current capacity.
- Assist QC management during all inspections and regulatory audits with emphasis on sample and retain/reserve management.
- Oversee the execution of sample handling investigations (missing samples, temperature excursions, etc).
- Draft and review of QC-sample management/materials documents (SOPs, Protocols, Reports etc).
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- BS in Biology, Chemistry, or related field.
- 5+ years of Quality Control experience in the biopharma or medical device fields with at least 3 years of QC sample management experience.
- Understand current GMPs and ICH, FDA, USP, PDA, and EMA (Ph Eur) guidelines as applicable to retain, reserve, and test sample handling
- Comfortable and capable of operating in a fast-paced start-up environment handling multiple product lines and manufacturing operations.
- Be able to lift up to 30 lbs and work on your feet for periods of up to six hours.
- Be able to work in a laboratory environment wearing appropriate PPE.
- Have excellent communication skills, both written and verbal
- Be detail oriented.
- Be a self-starter, able to complete task without direct management oversight.
- Possess strong interpersonal - team player – skills.
- Have flexibility in their work schedule: early, late and weekend hours may be required
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.