Downstream Process Scientist - Antibody PD

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

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