Manager/Senior Manager, Quality Control – Stability
Manager: Associate Director , QC-External Operations
Department: Quality, 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. 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/Senior Manager to oversee the Quality Control – Stability and Reference Standard programs at our Brisbane, CA manufacturing and testing facility.
- Work with QC senior management to design, implement, and oversee a compliant, inspection ready QC Stability program.
- Develop stability protocols to evaluate long-term, accelerated and stressed storage conditions for each of Sangamo’s platform products (autologous cell therapy products, gene editing vectors, gene regulating vectors, and in-vitro protein replacement vector systems).
- Oversee the execution of all stability protocols managed via our CDMO partners – ensure the timely receipt and review of all stability data. Ensure externally generated stability data is trended in a timely manner.
- Manage the execution of all in-house stability protocols – coordinate with QC testing labs to ensure all testing is executed within the acceptable stability timepoint windows.
- Work with the Formulation Development group to design and support in-use stability programs.
- Work with Analytical Development groups to design characterization and stability programs for in-house generated reference materials.
- Work with Sangamo Quality Assurance to establish/extend product shelf-life.
- Trend all stability data and work with QC senior management to resolve all stability failures. Lead investigation of stability OOS and OOT results.
- Manage stability calendars for all ongoing stability programs.
- Assist QC management during all inspections and regulatory audits with emphasis on stability data and shelf-life determination/extension.
- Draft and review of QC-stability documents (SOPs, Protocols, Reports etc).
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Possess a BS in Biology, Chemistry, or related field.
- Have 5-8 years of Quality Control-Stability experience in the biopharma or medical device fields. An understanding of the QC testing required for gene and cell therapy products is highly desirable.
- Understand current GMPs with a familiarity of ICH, FDA, USP, and EMA (Ph Eur) guidelines as applicable to stability testing and the establishment/extension of product shelf-life.
- Have experience with statistical analysis as related to interpretation of stability data.
- Be able to operate in a fast-paced start-up environment handling multiple product lines and manufacturing operations.
- 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
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.