Manufacturing Associate -Up Stream/ Cell Culture 1805
With three facilities in the USA and Europe, our client provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production.
Or client is currently looking for a Manufacturing Associate to join the Upstream/Cell Culture subdivision of the Manufacturing team. This is an exciting opportunity to work collaboratively in executing biopress operations primarily in Cell Culture/Upstream manufacturing and well as CIP/SIP operations (cleaning, assembly, sterilization, disassembly, operation of primary process equipment). The ideal candidate possesses strong computer and multi-tasking skills, strong verbal and written communication skills, and experience working in a fast-paced, dynamic environment with limited supervision.
- Executes bioprocess operations successfully primarily in Cell Culture/Upstream manufacturing
- CIP/SIP operations: cleaning, assembly, sterilization, disassembly, and operation of primary process equipment
- Unit operations described in standard operating procedures and batch records (50%-100% of effort)
- Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency
- Trains Manufacturing Technicians on theories and concepts of the bioprocess operations
- Completes required processing documentation including deviation reports, change control, product changeover, etc.
- Identifies, creates and revises GMP documentation as required including MBRs
- Performs review of GMP documentation and participates in training and development opportunities to gain understanding of compliance requirements and departmental policies.
- Participates in validation activities including IQ/OQ/PQ and process validation
- Assists in compliance and technical development projects
- Performs document revisions to Standard Operating Procedures
- Initial training and application of GMP regulations (ICH Q7A) as it applies to job function
- Other duties as assigned
- Bachelor’s Degree and 5+ years of relevant work experience
- Proven experience working in Cell Culture/Upstream manufacturing operations
- Proven experience and knowledge in bioprocess operations such as filtration, purification, cell culture or recovery.
- Working knowledge in relevant math, science, and engineering disciplines
- Ability to Communicate, read, and write legibly in English, as well as possession of strong technical writing skills
- Ability to apply advanced computer skills including work with spreadsheets(Excel) and word processing (Word)
- Ability to manage time effectively
- Detail oriented with ability to complete written and verbally assigned tasks following specific procedures
- Prior experience in aseptic processing and ability to apply excellent aseptic technique
- Working knowledge of GMP regulations (ICH Q7A), as well as experience with equipment and technology as it applies to job function
- Ability to interact constructively with peers and support groups, using organizational and communication skills necessary to plan and execute work flow