Sr BioProcess Engineer, MS&T

About the role

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, ensuring manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved.

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.

Responsibilities

• 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 supply and operational compliance.
• Support new processes, equipment, facility design, and other life-cycle activities to improve quality, efficiency, capacity, and economics.
• Work independently with minimal supervision, exercising latitude in determining technical objectives and approaches for major assignments.
• Serve as system owner for multiple focus areas within MS&T, such as Process Monitoring, Process Validation, Technology Transfer, and Continued Process Verification.
• Maintain strong working relationships with internal and external partners, including Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, and EHS.
• Guide the successful completion of major programs and function in a project leadership role.
• Participate on the MS&T Leadership Team to align resources with technical challenges and operational needs.
• Provide fast-paced campaign support during technical production issues or escalations.
• Represent MS&T as the prime technical contact on contracts and projects.
• Support manufacturing teams in developing platform procedures, batch records, training, and other resources for process execution.
• Review and approve manufacturing SOPs, forms, batch production records, deviations, CAPAs, and CCRs.
• Develop and maintain structured process data reviews for internal and external production.
• 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 team members.
• Evaluate and develop advanced technological ideas, summarizing findings in final reports.
• Design experiments for cell line development and optimization, analyze data, and formulate conclusions.
• Lead 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 process development and optimization.
• Troubleshoot and maintain cell culture and purification systems.
• Train team members in technical and operational skills.
• Safely handle serum, tissues from preclinical studies, human-origin samples, BSL-2 reporter viruses, and tissue samples under a BSC.
• Supervise daily activities of interns, co-ops, and contractors to ensure safety and effectiveness.
• Assist in onboarding and training new staff or junior employees.
• Mentor junior staff on technical and operational skills.

Requirements

• BS, MS, or PhD in Science or Engineering with a minimum of (BS+8 years), (MS+6 years), or (PhD+4 years) of relevant experience in the biopharma or pharmaceutical industry.
• Solid technical leadership in multiple 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.
• Strong teamwork skills and high personal accountability.
• Understanding of MS&T activities, including Technology Transfer, Process Development, QbD/PAT, Process Characterization and Control, and Process Validation.
• Comprehensive technical knowledge with a science- and risk-based mindset.
• Understanding of scientific methods, statistical analysis, and standard lab notebook format.
• Robust technical and communication skills (oral, written, and listening).
• Proficiency in Microsoft Office, statistical software (JMP/MiniTab or equivalent), Visio, and MS Project.

Preferred Qualifications

• Strong organizational skills, personal accountability, and proven planning and multitasking abilities.
• Awareness of emerging technology, digital transformation, and industry trends.
• Direct experience in tech transfer, engineering, quality, and regulatory functions.
• Expertise in project management, including planning, tracking, budget/schedule adherence, and communication.
• Good understanding of drug product processes.
• Hands-on experience with high-throughput bioreactor systems.
• Ability to search scientific literature for topic-specific information.

Pay

The estimated annual base salary for this position ranges from $129,000 to $156,000. Individual base pay depends on factors such as education, experience, skills, internal equity, and market alignment. The salary may also be adjusted based on geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonuses, and long-term incentives in the form of stock options.

Benefits

Emergent offers a comprehensive benefits package. Eligibility for benefits is governed by applicable plan documents and policies. Additional details can be found here.