GMP Manufacturing Lead/Associate
Company: GenVivo, Inc.
Posted on: February 13, 2019
GenVivo's mission is to develop innovative gene therapies to treat cancer and prolong patient survival while improving quality of life. Our approach to synergistically kill tumors while activating the immune system to fight the patient's cancer combined with the integration of novel companion diagnostics, positions us on the cutting edge of cancer immunotherapies and emerging clinical stage cancer companies. We are an ambitious, growing company whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission and values. The company thrives on collaboration and since we are currently small, every individual and each idea is important and counts.
General Job Description
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery, development and manufacturing, the successful candidate will be part of a skilled GMP Manufacturing team working to execute GMP production runs to supply the company's clinical pipeline. Other responsibilities include meeting with vendors to negotiate and procure equipment, leading and supporting IQ/OQ activities for facility and process equipment, creating SOPs and Batch records, establishing operational policies and procedures, writing and assisting in deviation report closures, and other activities to ensure a successful production campaign.
Primary Duties and Responsibilities include but are not limited to:
- Perform GMP operations in Cell Culture, Purification, Formulation, Tangential Flow Filtration and Filling
- Perform aseptic operations in the BSC/LFH with good aseptic technique
- Work as part of a small team to execute GMP runs in close collaboration with Process Development
- Transfer process from lab-scale to GMP-scale in support of creating material for early stage clinical studies
- Effectively engage cross-functionally with other departments in order to stream-line all operations supporting cGMP manufacturing
- Inventory management
- Generate, review and/or revise GenVivo batch production records, logbooks, and SOP's to support manufacturing operations
- Support and execute media and buffer preparation
- Upstream/Downstream equipment setup, operation, maintenance, and sanitization
- Gain understanding of Cell Culture and Purification theories and principles
- Successfully report and troubleshoot processing and equipment issues
- Maintain and sustain all organizational training profile requirements
- Comply with all GenVivo safety requirements, cGMP, GenVivo SOP's and manufacturing documentation
- Maintain appropriate interpersonal relationships with all members of management, company employees, service providers, technical support staff and all others associated with, relating to or doing business with the company.
The ideal candidate must have:
- Bachelor of Science degree or higher
- Minimum of 2 years of experience in cGMP operations (working with manufacturing equipment preferred)
- High degree of self-motivation and initiative
- Ability to work under pressure and against tight timelines
- Ability to work as part of a team and work independently with supervision
- Strong commitment to working safely
- Ability and willingness to work flexible hours when necessary (off-shift and long hours as required)
- Excellent written and verbal communication skills
- Mechanical aptitude, and working knowledge of computer systems
- Ability to lift 30 lbs
- Ensures project deadlines and performance standards are met
- Professional integrity and maturity with high degree of discretion dealing with confidential information
- Eligibility to work in the U.S.
Keywords: GenVivo, Inc., Pasadena , GMP Manufacturing Lead/Associate, Other , Pasadena, California
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