Senior Scientist, Process Development (Gaithersburg, MD, US, MD 20878)

Biopharma Careers; Gaithersburg (MD); On-site; USD 114,000 - 182,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Life, AD&D, Critical Illness Insurance

Pre-tax HSA & FSA, DCRA Spending

Employee Assistance & ConciergeProgram

Parental and Childbirth Leave & Family

401(K) Plan with Company Match

Tuition Reimbursement & Student Loan

Wellbeing Incentives

Professional Development

Commuting Allowance & subsidized PARK

Discounted Home, Auto & Pet Insurance

Job summary

BioNTech in Gaithersburg, MD is seeking a Senior Scientist I in Process Development to lead downstream purification efforts and support CMC strategy for regulatory submissions. You will guide scalable purification processes, drive process characterization studies, and contribute to PPQ readiness in a collaborative, lab-based environment.

The role requires a PhD or MS with extensive industry experience in monoclonal antibodies or related biologics, with strong leadership, data-driven decision

Qualifications

• PhD or MS with extensive experience in downstream processing and biologics.
• Experience designing and executing scale-up and technology transfer.
• Strong understanding of CMC processes and PPQ readiness for regulatory submissions.

Responsibilities

• Develop and qualify scale-down models for downstream purification to support mAb manufacturing.
• Execute studies and FMEA to establish CPPs and PRAs for process characterization.
• Lead development, optimization, and characterization of downstream processes including scale-up and viral clearance.
• Conduct downstream unit operations such as depth filtration, chromatography, viral inactivation, filtration, and TFF.
• Collaborate with cross-functional teams for experimental design, data analysis, and tech transfers.

Skills

Downstream processing

Process characterization

Scale-up

Cross-functional leadership

Regulatory knowledge

Education

PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related

MS with 8+ years in industry

Job description

Gaithersburg, US | full time | Job ID: 11410

About the Role:

As a Senior Scientist I in Process Development at BioNTech, you will play a key role in advancing our antibody pipeline, which is central to our therapeutic strategy. This position offers the opportunity to actively contribute technical leadership to downstream processing development while supporting CMC strategy for regulatory submissions. You will be part of a dynamic, lab-based team that thrives on collaboration and innovation to drive impactful results.

In this role, you will leverage your expertise in downstream processing to develop scalable purification processes, optimize manufacturing workflows, and ensure compliance with global regulatory standards. Your ability to distill complex data into actionable insights will be critical in shaping BioNTech’s success in delivering novel therapies to patients worldwide.

Your Contribution:

• Develop and qualify scale-down models for downstream purification processes to support monoclonal antibody manufacturing
• Execute studies and FMEA assessments to establish critical process parameters and proven acceptable ranges for process characterization
• Lead development, optimization, and characterization of downstream processes, including scale-up, virus/impurity clearance, and resin/membrane lifetime
• Conduct downstream process unit operations such as depth filtration, chromatography, viral inactivation, viral filtration, tangential flow filtration, and formulation
• Collaborate with cross-functional teams to design experiments, analyze results, support technology transfers, and meet project timelines
• Contribute to CMC documentation by drafting process descriptions, characterization reports, QbD risk assessments, and other technical reports
• Drive the creation of best practices and workflows for process development in a fast-paced environment

A Good Match:

• PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related discipline with 6 plus years of relevant experience (including post-doctoral training), or MS with 8 plus years of industry experience
• 6 years’ experience in global pharma PD or MS&T for monoclonal antibodies or related biologics
• Expertise in downstream process development including scale-up and technology transfer
• Proven ability to design and execute process characterization studies using scale-down models that inform PPQ strategy
• Strong understanding of biologics CMC processes including PPQ/BLA readiness; experience with antibody or ADC development preferred
• Demonstrated technical leadership within cross-functional teams and programs
• Willingness to travel domestically and internationally as required by program needs

Your benefits and remuneration:

Expected Pay Range: $113,600/year to $181,600/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

• 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
• …
• and more! More details to be shared.

Location and Community:

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.