Bioprocess Associate

My client is a Bioprocess Associate for a contract opportunity. You will be responsible for all procedures and processes associated with the Manufacture of Commercial Large-Scale Drug Substance at the manufacturing facility. The Bioprocess Associate will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing and basic maintenance of equipment in accordance with current Good Manufacturing Practices (cGMPs).

The role:

Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of the manufacturing facility. Support Equipment Design/ HAZOP and Room programming reviews. Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training. Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures. Generate SOPS/Electronic Batch Records. Adhere to Right First-Time principals. Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested. Escalate issues as appropriate to Process Lead Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan

Key Attributes

Ability to work cross functionally and with multiple stakeholders. Troubleshooting capabilities. Understanding of Drug Substance Manufacturing Operations. Understanding of GMP requirements in a Bio-pharmaceutical Facility. Excellent communication skills. Ability to multitask.

Qualifications/ Education

Level 7 qualification in a science or engineering discipline. Or a level 6 with a minimum of 3 years' experience in a GMP Manufacturing requirement shall be deemed equivalent.

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