Senior Process Engineer – Manufacturing*
- Gaithersburg, Maryland
- Work experience
- Production, manufacturing
Senior Process Engineer – Manufacturing*
BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.
BioNTech is seeking a highly-motivated Senior Process Engineer - Manufacturing who will be responsible for leading projects associated with establishing robust and compliant manufacturing processes through technology transfer, process scale-up, process qualification, product comparability and regulatory submissions. Lead manufacturing projects for quality improvement, implementation of lean practices and capacity expansion. Own and maintain the knowledge and history of BNT products and processes throughout product lifecycle. Prepare and review technical documents such as batch records, sampling plans, process-related SOPs, risk assessments, study protocols, technical reports and/or summary sections for regulatory submission files. Provide first-line technical support to manufacturing, focusing on quality, safety, on-time delivery in compliance with relevant instructions and quality requirements.
Here, you’ll achieve greatness.
- Facilitate seamless flow of knowledge and information across functions and coordinate input of project plans cross-functionally with Development, Quality Assurance, Quality Control, Regulatory, Engineering and Metrology, other functions as may be applicable.
- Support planning and execution of process characterization and validation/verification studies and improvement/operational excellence projects.
- Use scientific rational, statistical and other appropriate tools for data analysis. Contribute to process understanding, identifying key sources of variability and root causes of product and process failures.
- Lead or support change review and implementation, quality investigations, CAPAs in cross-functional teams.
- Be a resource to other departments as a Subject Matter Expert for the product and process knowledge.
- Participate in selection of process equipment by providing input to User Requirements (URS), evaluation of available options and creating associated risk assessments and procedures.
What you have to offer.
- Minimum requirements; Bachelors degree with 6 plus years of experience in clinical and/or commercial GMP manufacturing of biologics
- Experience in Technology Transfers of Biologics and/or Cell Therapy products
- Expertise in mammalian cell/viral culture, bioreactor operations and related techniques.
- Project management experience.
- Good leadership and people skills, teamwork experience, demonstrated conflict resolution ability and negotiation skills.
- Prior experience with Cell and Gene Therapy products and processes is a plus.
- Operational Excellence experience using Lean, Six Sigma or other continuous improvement methodologies with demonstrated results (Lean certification a plus).
- Comfortable in a fast-paced environment with ability to manage a variety of projects simultaneously and handle rapidly changing priorities.
- Self-starter who functions well with minimum supervision.
- Expert MS Office skills with a specific focus on word processing, spreadsheets, presentations, graphics, slides and templates, in addition to Adobe Acrobat and other relevant software applications.
Preferred requirements; GMP manufacturing of biologics for cell therapy.
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!