Senior Engineer I / II (Clinical Manufacturing) - Permanent Job

Company Name:
Senior Engineer I / II (Clinical Manufacturing)
needed for a
direct hire
opportunity Yoh's client located in the Cranbury, NJ area.
What You'll Be Doing:
- Play a lead role in the technology transfer of upstream and downstream processes from process development labs to internal clinical manufacturing and external commercial manufacturing facilities.
- Creation and revision of documentation, including but not limited to equipment specifications, qualification protocols, technology transfer documentation, master batch records, standard operating procedures, production bill of materials, and process flow diagrams under QbD philosophies
- As production schedule requires, performs upstream and downstream process operations as needed.
- Champions risk-based documented approaches in collaboration with Process Development, Manufacturing and Quality Assurance
- Ensures critical processing parameters have been defined in cGMP documentation
- Develops training requirements for staff and assures that training is effective
- Works diligently to meet scheduled timelines, especially as required to meet production schedule.
- Participate in starting up facility and process equipment. Partner with vendors to deliver state of the art technologies.
- Innovate technologies that embrace QbD, continuous improvement, reduce manufacturing costs and increase manufacturing efficiency.
- Follow full cGMP guidance and fulfill all regulatory requirements at all times.
- Operate safely and according to company environmental requirements.
- Evaluate technologies and propose ideas for innovation.
- Support business development activities as required.
- Present data or ideas in team meetings.
- Follow all company best practices to minimize cost and meet budgetary requirements.
- Management team may assign other responsibilities as required.
What You Need to Bring to the Table:
- BS in Engineering Discipline, preferably Chemical Engineering.
- Four to eight (4-8) years of experience with demonstrated ability in clinical cGMP bioprocess operations and scale-up, particularly downstream processes, of mammalian expressed glycoproteins or mAbs.
- Working knowledge in the principles of process scaling from process development to clinical manufacturing as well as single-use technology.
- Excellent communication skills that facilitate operations in cross functioning groups.
Bonus Points! Otherwise Known As Preferred Qualifications:
- Experience/ knowledge of biosimiliar process development/ manufacturing is a plus.
If This Sounds Like You, Apply Now!
Sidra Javed
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer,
Ref: 1033971

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