- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a Stability and Metrics Program Manager in QC Commercial Group to manage company stability and metrics programs for company critical raw materials and final products.
Responsibilities (include but are not limited to):
- Develop strategy for developing stability and method performance monitoring programs for company’s products and raw materials.
- Write stability protocols for short term, long term, accelerated stability, post thaw stability and shipping validation protocol.
- Develop Forced Degradation studies
- Interact with the QC Laboratory personnel to plan and schedule testing at scheduled time points
- Write interim and final stability reports
- Assist in implementing Stability programs into Laboratory Information Management (LIMS) Systems
- Author protocols and technical documents and provide summary stability reports from LIMS.
- Collect, trend, analyze and report method performance monitoring data.
- Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.
- Able to clearly present results of work, interpret data using standard statistical software and draw conclusions.
- Perform other duties as assigned as on need basis
- B.S. with 8-10 yrs, M.S. with 5-7 yrs and Ph.D. with 3-5 yrs experience in a pharmaceutical or in other FDA regulated environment
- Demonstrated successful management of stability programs for biological products.
- Strong experience in analytical methods such as Cell Based Assays, PCR, Flow cytometry, ELISA and other routine analytical assays.
- Experience with a LIMS system preferable
- Deep understanding of experimentation and data analysis using different statistical software packages (JMP experience preferred)
- General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
- Experience in data management, change control, GMP and compliance.
- Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience.
- Ability to communicate complex scientific findings and recommendations in one-on-one discussions and in departmental meetings.
- Excellent technical writing experience in a regulatory environment such as SOPs, protocols, and reports
- Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment.
- Strong computer, scientific, and organizational skills.
- Ability to work independently and as part of a team with internal and external teams with excellent communication skills
- Exceptional analytical skills to evaluate the importance and urgency of problems; demonstrated interpersonal, verbal and written communication skills.
- Ability to prioritize, manage multiple tasks, and meet deadlines.
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.