PharmEng Technology is currently seeking a Senior MS&T Engineer
in Raleigh-Durham, NC. The position is available immediately conditional of a successful interview.
- Act as a scientific and technical lead for process-related issues and investigations.
- Partner with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
- Mentor and train engineering team members.
- Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality.
- Work with Global team to define process improvements; lead implementation of process changes.
- Participate in start-up efforts of new equipment, software or processes in manufacturing.
- Develop, communicate, and implement strategic planning for business development and future improvements.
- Assist in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
- Provide technical/scientific support on project deliverables.
- Utilize small-scale production processes and scaled-down lab processes to enable process troubleshooting, oversee these experiments at other locations as necessary.
- Provide leadership for tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
- Partner with Quality to ensure a compliant manufacturing environment.
- Assist the technical operations team in resolving any issues related to production.
- PhD in biochemistry, chemical engineering, bioengineering, or related technical field and at least 8 years of experience in support of biopharmaceutical manufacturing or
M.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 10 years of experience in support of biopharmaceutical manufacturing or
B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 12 years of experience in support of biopharmaceutical manufacturing.
- Excellent oral and written communication skills.
- Experience in cell culture, recovery, purification, and/or aseptic fill/finish.
- Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements.
- Strong technical writing ability.
- Proven ability to effectively lead and participate on teams.
- Leadership of technical staff.