Manufacturing Associate II (Upstream) 2150
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 II to execute upstream (cell culture) bioprocess unit operations in support of GMP clinical manufacturing, such as cell culture vial thaw and passaging, cell expansion in 20-40L vessels or WAVE bioreactors, and operation of stainless steel bioreactors (500-2000L) with automated control systems. 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.
- Execute upstream (cell culture) bioprocess unit operations in support of GMP clinical manufacturing, such as cell culture vial thaw and passaging, cell expansion in 20-40L vessels or WAVE bioreactors, and operation of stainless steel bioreactors (500-2000L) with automated control systems
- Execute harvest/recovery operations using depth filtration technology.
- Execute routine bioprocess support operations such as parts cleaning, autoclaving, media preparation, CIP and SIP, and bioreactor and sterile component assembly
- Perform process equipment preventative maintenance as required
- Assist in training junior associates on theories and concepts of upstream bioprocess operations.
- Ensures that standard operating procedures are followed and are correct for bioprocess operations and equipment.
- Create and revise SOPs as needed
- Perform review of GMP process documentation (batch records and log books).
- Complete required processing documentation including deviation reports, change control, product change over, etc.
- Assist in the onboarding of new GMP process equipment, participate in equipment commissioning and operational qualifications
- Work with floor supervisor to organize work flow on their shift.
- Ensure acceptable quality and quantity of work executed.
- Ensure compliance with company quality systems, safety procedures, and other company policies.
- Other duties as assigned
- Bachelors degree or equivalent work experience
Key Competencies and Experience
- 2-5 years of relevant bioprocess experience
- Communicate, read, and write legibly in English
- Detail oriented with the ability to complete written and verbally assigned tasks, following specific procedures
- Ability to interact constructively with peers and support groups
- Relevent knowledge in math, science and engineering disciplines
- Strong computer skills including use of spreadsheets (MSExcel) and word processing (MSWord)
- Strong understanding of cGMP regulations (ICH Q7A) as it applies to job function
- Excellent aseptic technique
- Working knowledge of mammalian cell culture techniques
- Solid understanding of SIP bioreactor operations, experience with bioreactor automation/control systems
- Knowledge of single use mix systems
- Demonstrates solid critical thinking skills, problem analysis and problem solving for continuous process improvement
- Exercise appropriate judgement in application of industry practices and company policies to daily operations
- Exemplary team player offering proactive assistance wherever needed
- Demonstrates full engagement, motivated to make a difference
- Must be comfortable working in an environment under development, demonstrating adaptability and flexibility, without sacrificing compliance requirements