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Engineer
4 months ago
REMOTE - east coast time zone preferred.
Ideal Candidate: 3-5 YOE in the tech transfer space. Education background in Chemical Engineering, Bioengineering or Biotechnology. worked in the commercial pharma space. 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes. Tech transfer documentation. prefers candidates with both lab and manufacturing experience but would prefer manufacturing experience over lab.
Candidate will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Client manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.
- Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules.
- Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
- Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
- Initiate and complete routine technical tasks associated with Technology Transfer.
- Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
- Apply engineering principles and statistical analysis, including design of experiments, in-order to address processing issues and evaluate opportunities for process improvements
- Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
- Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
- Support non-standard shift organization and extended hours, as per business needs.
Preferred Qualifications:
- Education background in Chemical Engineering, Bioengineering or Biotechnology
- 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
- Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
- Experience working with commercial manufacturer of biologics using single use technology
- Basic understanding cGMP requirements; Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
- Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules. Experience working with data and digital tools preferred.
- Proficient re: the analysis of data generated from an array of analytical techniques
- Regulatory knowledge and interactions and project management skills
- Strong oral and verbal communication and presentation skills
