Description: Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Summary: This is a senior scientist position within the CAR T technical transfer & clinical manufacturing support group. The scientist should work independently to develop and carry out laboratory based analytical methods, manage analytical method transfer and qualification, and support QC activities and troubleshooting. Activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
Responsibilities may include, but are not limited to, the following:
- Develop and qualify PCR based method and author qualification protocol and report.
- Manage analytical method transfer from development to QC. Author/review transfer protocol and report.
- Participate in the execution of analytical method qualification. The methods may include qPCR, flow cytometry, ELISA, cell counting and microbiological/safety, etc.
- Work as a SME for qPCR methods to support QC activities, lead troubleshooting for analytical issues.
- Author and review standard operating procedures as required.
- Perform tracking/trending of data to contribute to the life-cycle management of an analytical method.
- Train end-users and entry-level personnel on analytical methods.
- Good communication skills and be able to work with facility, development, technical operations, QC, QA and CRO. Build relationships with cross-functional teams.
- Work with team to establish a tech transfer laboratory. Manage equipment procurement and coordinate equipment IQ/OQ.
- Maintain a basic knowledge of cell therapy development and awareness of competitive landscape.
- Ensure proper operation and perform routine maintenance of all laboratory equipment. Ensure that all equipment and personnel are and remain in compliance with cGLP/cGMP, FDA and EMA requirement, appropriate SOPs and corporate policies.
- Maintain a safe workplace in accordance with company and OSHA policies/procedures.
- B.S. or M.S in Biology or related discipline with 7+ years of recent, relevant experience or Ph.D. with 3+ years of recent, relevant experience.
- Must have experience of molecular biology-based assay development. Flow cytometry is a plus.
- Proficiency in analytical skills: statistical analysis and effective presentation of analysis to other groups.
- Strong verbal and written communication skills and interpersonal skills.
- Ability to write scientific technical protocols, reports and SOPs that require minimal revision on content.
- Ability to work with minimal technical supervision and perform operational tasks independently.
- Able to assess risk and develop contingency plans for process risks.
- Highly motivated and driven to acquire new skills.
- Expertise in mammalian cell culture and diverse analytical techniques preferred.
- Experience working in a GMP regulated environment. Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines
Application procedure: To apply, please send your cover letter and CV/resume to Greg Russotti (firstname.lastname@example.org)
Location: Warren, NJ