Senior Manufacturing Engineer
Our client seeks an entrepreneurial manufacturing professional to execute the manufacturing strategy for clinical and commercial vector, plasmid, and small molecule supply at their contract manufacturing (CDMO) partner. We are interested in candidates with a proven track-record in GMP manufacturing to help achieve their goal of delivering therapies that transform the lives of patients.
As a Senior Manufacturing Engineer reporting to Director, Manufacturing, you will be responsible for:
- Acting as a point of contact for a CMO and shares best practices among peers.
- Independently manage the review of batch records and in-process results and partner with Quality to complete deliverables required for disposition of batches.
- Proactively identify issues in the manufacturing process and solve them.
- Facilitating and own internal and external working team meetings.
- Proactively spot process improvements and suggest a plan and approach for new initiatives.
- Capable of serving as the primary Person in Plant for a CMO.
- Owning change controls, deviations, investigations, and CAPAs as necessary.
- Working closely with the company’s internal process development and MSAT groups to execute process characterization, technology transfer, and validation for commercial supply.
- Providing the technical expertise around manufacturing for technical reports and regulatory submissions.
- B.S. in engineering or life sciences, with 6+ year’s relevant industry experience. Advanced degrees desirable.
- Strong understanding of cGMPs is a must. Ideally Fill/Finish
- Preferably with PPQ and start up experience for new equipment or process qualification
- Experience with producing and purifying biologics and/or commercial biologics manufacturing is strongly preferred.
- Highly organized and detailed oriented
- Experience with technology transfer or vendor management is preferred.
- Experience with process characterization and validation is a plus.
- Should be highly motivated, collaborative, and be able to multitask in a fast-paced environment with changing priorities.
- Must be able to work both independently and as part of a multi-disciplinary team.
- Excellent communication skills and ability to influence across multiple functions.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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