Sr BioProcess Engineer, MS&T

Sr Bio Process Engineer, MS&T

Location:

Canton, MA, US, 02021

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

JOB SUMMARY

The Senior Bio Process Engineer will provide technical leadership on major development-, manufacturing-, and tech transfer-related projects. The incumbent will plan, coordinate, communicate, and summarize projects. The incumbent should have solid education, technical and organizational leadership, and proven development and CGMP experience to support MS&T mission, i.e., to ensure that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. The MSAT department at the Canton site of Emergent Bio Solutions ensures that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved. Our core responsibilities include:

• Enable reliable supply of vaccines and therapeutics by providing direct scientific and technical leadership to commercial manufacturing operations.
• Anticipate, respond to, and permanently resolve manufacturing issues to safeguard our right to operate and supply.
• Support new processes, equipment, facility design, and other life-cycle activities to improve quality, efficiency, capacity, and economics.
• Business Work independently with little to no supervision. Exercise considerable latitude in determining technical objectives/approaches to major assignments. System owner responsibilities for multiple focus areas within the MS&T function, e.g., Process Monitoring, Process Validation, Technology Transfer, Continued Process Verification, etc. Maintain good working relationships with internal and external partners/customers, i.e., Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, EHS, etc. Guides the successful completion of major programs and may function in a project leadership role.
• Participate on MS&T Leadership Team to ensure appropriate alignment of resources to technical challenges and routine operational needs.
• Technical Provide fast-paced campaign support for manufacturing during technical production issues or escalations. Represent MS&T as the prime technical contact on contracts and projects. Work with manufacturing teams to provide technical support to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes. Support existing business processes such as reviewing and approving MFG SOP/FRM/BPR document revisions, deviations, CAPAs, CCRs.
  
  Develop and maintain structure for process data reviews for internal and external production. Develop and draft study plans and protocols as required to support process changes, deviation responses, and regulatory requirements, etc. Lead process investigations and drive process improvement initiatives. Review technical documents authored by the other team members. Evaluate and develop advanced technological ideas and summarize their development into final reports.
• Scientific Designs experiments for the development of cell lines and optimization of cell line production processes; analyzes the data from such experiments and participates in the formulation of conclusions and next steps. Serves as lead for tech transfer of cell culture and purification processes to internal departments. Develops and maintains cell lines and cell banks Writes and executes experimental protocols for developing/optimizing processes for potential use in manufacturing.
  
  Trouble-shoots and maintains cell culture and purification systems. Trains other members of the team in techniques. Safely handle serum and/or tissues from preclinical studies as well as samples of human origin. Safely handles BSL-2 reporter viruses and tissue samples under a BSC.
• People Management/Employee Development Supervise daily activities for Intern/Co-op students and contractors to ensure safety and effectiveness Assist Manager in bringing new staff up to speed. Train new employees or junior staff on hands-on skills Mentor junior staff on technical and operational skills

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

BS, MS, or PhD in Science or Engineering with a minimum of (BS+8yrs) /(MS+6yrs)/…