More jobs:
Downstream Purification Scientist, MSAT, New Mfg. Facility
Job in
Lebanon, Boone County, Indiana, 46052, USA
Listed on 2026-08-03
Listing for:
Eliassen Group
Full Time
position Listed on 2026-08-03
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer
Job Description & How to Apply Below
On-site in Lebanon, IN
Our client seeks a Downstream Purification Scientist to provide technical leadership and execution support for downstream purification activities associated with gene therapy drug substance manufacturing. The role supports technology transfer, process implementation, manufacturing readiness, and documentation for clinical and commercial production. The position supports documentation activities and frontline manufacturing operations and reports to the Head of Advanced Therapies at the site.
According to client requirements, applicants must be willing and able to work on a w2 basis.
Benefits:- Medical, Dental, and Vision benefits
- 401k with company matching
- life insurance
Rate: $65.00 to $75.00/hr. w2
Responsibilities:- Provide technical support for downstream MSAT technology transfer activities.
- Lead and facilitate discussions related to process lock, process optimization, and unit operation finalization.
- Prepare, review, and provide technical input to manufacturing and technical documentation.
- Author, review, and approve Master Batch Records (MBRs) and Electronic Batch Records (EBRs).
- Track M /E development status, progress, and turnaround timelines.
- Support Operational Readiness Plan deliverables for the manufacturing site.
- Serve as the downstream purification representative during internal, global, and external partner meetings.
- Support manufacturing floor activities and provide technical troubleshooting as needed.
- Identify technical issues, process deviations, and project risks, escalating concerns appropriately to management.
- Provide timely communication regarding critical manufacturing or project issues.
- Support continuous improvement initiatives while ensuring compliance with cGMP requirements.
- Previous MSAT experience supporting downstream purification processes for gene therapy or mAb/large molecule manufacturing.
- Experience with in pharmaceutical manufacturing and GMP-regulated environments.
- Experience supporting commercial manufacturing processes and developing Master Batch Records.
- Working knowledge of cGMP data integrity principles, including ALCOA+ requirements.
- Demonstrated project management skills with the ability to manage priorities and meet timelines.
- Strong technical writing, communication, and documentation skills.
- Bachelor's, Master's, or Ph.D. in Chemical Engineering, Biochemistry, Biology, or Biotechnology.
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