Quality Assurance Manager
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases.
We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology.
Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
The QA Manager will be a key member of the Quality team reporting directly to the Senior Director of Quality. This is an exceptional opportunity to gain experience in a successful biotech company. Job title will commensurate with the level of experience and skill sets.
Responsibilities include, but are not limited to:
- Manage review and approval of analytical method validation protocols and support method transfer as needed in support of release testing of drug substances and drug products at CMO
- Manage review and approval of Master Batch Record (MBR) to comply with good manufacturing practice regulations, regulatory filings and quality agreements
- Manage review of executed batch records, Certificates of Analysis and other documents to release drug substance and final drug product for the intended use
- Manage review and approve changes to methods, processes and specifications, deviations and OOS/OOT
- Manage electronic systems for administrating document and system change control requests
- Work collaboratively with CMC core team to develop and implement manufacturing and regulatory drug substance and drug product specifications
- Be flexible and prepared to perform other related tasks as assigned
- Other duties as assigned
- Bachelor’s degree in biochemistry, molecular cell biology or related field required. Advanced degree is desirable
- At least 8 years of experience in the biotechnology industry in the areas of drug development and manufacture of clinical materials and/or commercial products with at least 5 years of direct experience in the quality assurance/quality control area
- Prior experience working in the analytical/QC laboratory developing analytical methods supporting lot release of biologics is highly desirable
- In-depth knowledge of GMP and ICH requirements and applications for biologic drug substance and drug product manufacturing
- Prior experience with implementation and management of electronic documentation system
- Prior experience with supplier audit is desirable
- Excellent verbal and written communication skills are essential in this collaborative work environment
- Ability to discuss scientific/technical data with team members
- Comfortable in a fast-paced company environment that requires adjusting workloads based upon changing priorities and willingness to do whatever needs to be done, regardless of level or type of work
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.