Sr BioProcess Engineer, MS&T

Emergent Biosolutions•Canton, MA

7d•$129,000 - $156,000•Onsite

About The Position

The Senior BioProcess 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. The MSAT department at the Canton site of Emergent BioSolutions 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.

Requirements

BS, MS, or PhD in Science or Engineering with a minimum of (BS+8yrs) /(MS+6yrs)/ (PhD+4yrs) of relevant job experience in biopharma or pharmaceutical industry
Solid technical leadership in several functional areas and in-depth CGMP experience with vaccines/biologics manufacturing science and technology.
Experience working under a Quality Management System.
Ability to manage multiple priorities and tasks in a dynamic environment.
Ability to make sound scientific decisions regarding compliance-related issues with minimal supervision and guidance.
Work effectively in a team environment and have a high level of personal accountability and responsibility.
Understanding of MS&T activities including but not limited to: Technology Transfer Strategy and Implementation; Process Development, Product Process Improvement, QbD / PAT; Process Characterization and Control; Process validation
Comprehensive technical knowledge with a strong science-and-risk based mindset.
An understanding of scientific methods, statistical analysis, and standard lab notebook format.
Robust technical and communication skills: oral/written and listening.
Proficient in Microsoft Office and statistical and productivity software, i.e., JMP/MiniTab or equivalent, Visio, MS Project, etc.

Nice To Haves

Good organization skills; high-level personal accountability and responsibility; proven planning, organization, and multitasking skills.
Stay abreast of emerging technology, digital transformation, and industry trends.
Direct experience in tech transfer, engineering, quality, and regulatory.
Expertise with all aspects of project management skills, including planning, tracking, adhering to budget/schedule and communicating, etc.
Good understanding of drug product processes.
Hands-on experience with high throughput bioreactor systems.
Capable of searching scientific literature to gain information about specific topics.

Responsibilities

Provide technical leadership on major development-, manufacturing-, and tech transfer-related projects.
Plan, coordinate, communicate, and summarize projects.
Ensure that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved.
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.
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.
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.
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.
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.