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Form of workJob Description
The Manufacturing Associate is responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment.
Responsibilities:
- Use of MBRs(Master Batch Records) and SOPs to produce clinical material from cell expansion through downstream processing in non-GMP and GMP settings
- Develop and author Standard Operating Procedures (SOPs) and logbooks for equipment setup and operation
- Support integration of SOPs, MBRs, and logbooks into an electronic Manufacturing Execution System
- Maintain quality standards to meet cGMP requirements, CFR’s, and internal company policies directly related to the manufacturing process as required
- Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing
- Look for opportunities to implement operational excellence and continuous improvement within process operation and documentation
- Partner with Quality to ensure a quality and compliant manufacturing environment
- Assist the technical operations team to resolve any issues related to production
Requirements / Qualifications:
- A.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience
- Excellent oral and written communication skills, including technical writing
- Working knowledge of FDA regulations and GMP systems
- Proven ability to effectively lead and participate on teams
- Up to 20% travel required
- Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed
Preferred Qualifications:
- B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience
- Previous cGMP batch documentation authoring and lifecycle management experience
- Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds
- 2 years of experience in biologics-based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish
- Previous experience with single-use manufacturing
The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.
