Senior Scientist, Downstream Process Development Leader

Socket.dev; Gaithersburg (MD); On-site; USD 114,000 - 182,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(K) Plan with Company Match

Tuition Reimbursement & Student Loan

Paid Time Off

Commuting Allowance

Job summary

BioNTech US is seeking a Senior Scientist I in Process Development to drive downstream purification strategies for monoclonal antibodies and related biologics. You will lead scale‑up, parameterization, and technology transfers within a cross‑functional team, shaping CMC readiness and PPQ strategies.

The role emphasizes development, quality, and regulatory collaboration, with focus on scalable, compliant processes and a dynamic, lab‑based environment near Gaithersburg.

Qualifications

• PhD or MS with substantial post‑graduate experience in upstream/downstream pharmaceutical development.
• 6+ years global pharma PD or MS&T experience for monoclonal antibodies or related biologics.
• Expertise in downstream process development including scale‑up and technology transfer.

Responsibilities

• 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.
• 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.

Skills

Downstream processing

Scale-down models

Process characterization

Technology transfer

Cross-functional collaboration

Regulatory readiness

Leadership in PD

Education

PhD in Biomedical/Chemical Engineering or Biochemistry

MS with 8+ years industry experience

Tools

Chromatography

Depth filtration

Tangential flow filtration

Viral inactivation

Virus/impurity clearance

Job description

BioNTech US is seeking a Senior Scientist I in Process Development to drive downstream purification strategies for monoclonal antibodies and related biologics. You will lead scale‑up, parameterization, and technology transfers within a cross‑functional team, shaping CMC readiness and PPQ strategies.

The role emphasizes development, quality, and regulatory collaboration, with focus on scalable, compliant processes and a dynamic, lab‑based environment near Gaithersburg.