Downstream Purification Scientist, MSAT, New Mfg. Facility

Description:
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.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and 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.

Experience 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.

Education Requirements:

• Bachelor's, Master's, or Ph.D. in Chemical Engineering, Biochemistry, Biology, or Biotechnology.

Recruitment Transparency Notice

Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position.

All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.

Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
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About Eliassen Group:

Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional…