Process Engineer, Process Development

Biontech Ag - Gaithersburg, MD

Part-time - Mid Level

Gaithersburg, MD

Professional, Scientific, and Technical Services

About the position

As a Process Engineer in Process Development at BioNTech, you will play a pivotal role in the design, development, characterization, and qualification of cell production processes. This includes critical tasks such as cell processing, genetic modification, culture and expansion, harvest, and cryopreservation. You will be responsible for drafting Standard Operating Procedures (SOPs), reports, and presentations that document your findings and methodologies. Additionally, you will maintain and troubleshoot instrumentation that is commonly utilized by the process development team, ensuring that all equipment operates efficiently and effectively. Collaboration is key in this role, as you will work closely with both internal research teams and external groups to advance translational immunology capabilities. You will also support the transfer of developed processes to the Clinical Manufacturing Team, which includes training manufacturing personnel and reviewing batch record documentation to ensure compliance and accuracy. Data analysis will be a significant part of your responsibilities, and you will be expected to present results within your team and to broader scientific groups, maintaining a high standard of experimentation and record-keeping throughout. The position requires you to work productively both in a team environment and independently, delivering against timelines while managing multiple projects. Your contributions will directly impact the advancement of BioNTech's mission to develop innovative immunotherapies and vaccines for serious diseases.

Responsibilities

• Design, develop, characterize, and qualify cell production processes including cell processing, genetic modification, culture and expansion, harvest, and cryopreservation.
• Draft SOPs, reports, and presentations to document processes and findings.
• Maintain and troubleshoot instrumentation used by the process development team.
• Collaborate with internal research teams and external groups to enhance translational immunology capabilities.
• Support the transfer of developed processes to the Clinical Manufacturing Team, including training of manufacturing personnel and reviewing batch record documentation.
• Conduct data analysis and present results to the team and broader scientific groups.
• Maintain high standards of experimentation and record keeping.
• Work effectively in a team environment and independently to meet project timelines.

Requirements

• BS or MS in Biology or related discipline with 3-7 years of laboratory experience.
• Experience with automated cell processing and/or cell expansion technologies preferred.
• Experience working within CMC and Tech Transfer for cell therapy products preferred.
• Ability to prioritize tasks and manage multiple projects effectively.
• Detail-oriented with excellent documentation practices and strong oral and written communication skills.
• Experience working within a multi-disciplinary team and ability to integrate cross-functional information.

Nice-to-haves

• Experience in process development, analytical development, QC, and/or GMP manufacturing for cell therapy products.

Benefits

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance