Sr BioProcess Engineer, MS&T

Emergent BioSolutions • Canton, MI

5d • Onsite

About The Position

Emergent BioSolutions is a leading public health company focused on protective and life-saving solutions. The Senior BioProcess Engineer will provide technical leadership for major development, manufacturing, and tech transfer projects. This role involves planning, coordinating, communicating, and summarizing projects, requiring strong education, technical and organizational leadership, and proven development and CGMP experience to support the MS&T mission of ensuring manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved. The MSAT department at the Canton site is responsible for enabling reliable supply of vaccines and therapeutics by providing scientific and technical leadership to commercial manufacturing operations, resolving manufacturing issues, and supporting new processes, equipment, and facility designs to enhance 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.
• 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.
• 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.
• 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 direct scientific and technical leadership to commercial manufacturing operations to enable reliable supply of vaccines and therapeutics.
• Anticipate, respond to, and permanently resolve manufacturing issues to safeguard the company's 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.
• Serve as system owner for multiple focus areas within the MS&T function (e.g., Process Monitoring, Process Validation, Technology Transfer, Continued Process Verification).
• Maintain good working relationships with internal and external partners/customers (Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, EHS, etc.).
• Guide the successful completion of major programs and may function in a project leadership role.
• Participate on the 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.
• Support existing business processes such as reviewing and approving MFG SOP/FRM/BPR document revisions, deviations, CAPAs, CCRs.
• Develop and maintain a structure for process data reviews for internal and external production.
• Develop and draft study plans and protocols to support process changes, deviation responses, and regulatory requirements.
• Lead process investigations and drive process improvement initiatives.
• Review technical documents authored by other team members.
• Evaluate and develop advanced technological ideas and summarize their development into final reports.
• Design experiments for the development of cell lines and optimization of cell line production processes; analyze data and participate in formulating conclusions and next steps.
• Serve as lead for tech transfer of cell culture and purification processes to internal departments.
• Develop and maintain cell lines and cell banks.
• Write and execute experimental protocols for developing/optimizing processes for potential use in manufacturing.
• Troubleshoot and maintain cell culture and purification systems.
• Train other members of the team in techniques.
• Safely handle serum and/or tissues from preclinical studies as well as samples of human origin.
• Safely handle 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.

Benefits

• Comprehensive benefits package
• Eligibility for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior