Biologics Drug Product Process Development Scientist

Atrium; Boston (MA); On-site; USD 75,768 - 82,656; Full time

Job summary

Vertex is looking for a Biologics Drug Product Process Development Scientist in Boston to join their Process Development team. The ideal candidate will support the development and manufacturing of biologics drug products, focusing on formulation development and technology transfer. A Master’s or PhD in a related field with substantial industry experience is necessary. The role offers a dynamic, collaborative environment, Monday to Friday work hours, with pay ranging from $55/hr to $60/hr.

Qualifications

• Master’s or PhD in relevant field with 3-5 years of industry experience, or equivalent.
• Direct experience in biologics drug product development.

Responsibilities

• Support drug product development and scale-up activities.
• Develop robust fill-finish manufacturing processes.
• Establish clinical dose preparation protocols.
• Analyze stability data for product degradation pathways.

Skills

Formulation development

Analytical techniques

Data analysis

Technical writing

Scientific communication

Education

Master’s or PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or related discipline

Job description

Vertex is seeking a Biologics Drug Product Process Development Scientist to join our Process Development team to support the development and manufacturing of biologics drug products for our growing pipeline. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up, and cutting‑edge manufacturing technologies to enable the successful implementation of biologics, cell, and Genetic therapeutics.

The successful candidate will support the development and manufacturing of biologics drug products. The responsibilities include formulation development, primary container development, fill‑finish process development, and technology transfer of manufacturing processes to CDMOs to support our clinical pipeline.

Key Duties and Responsibilities

• Support drug product development, process transfer, and scale‑up activities.
• Assess molecule developability and determine formulation screening strategies for biologics, ADCs, and other biologics modalities.
• Develop robust fill‑finish manufacturing processes for liquid and lyophilized drug products in vials, pre‑filled syringes, and other novel primary packaging formats.
• Establish preclinical and clinical dose preparation and administration protocols for drug products.
• Analyze and trend stability data to understand product degradation pathways and inform development strategy.
• Author and/or review technical protocols, reports, and documentation to support development activities and technology transfer.
• Perform wet‑lab activities as needed to support program objectives.
• Located on‑site at our Boston Seaport location.

Required Education

• Master’s or PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or a related discipline, with 3‑5 years of industry experience, or equivalent years of education and experience; a PhD with 1‑2 years of industry experience, or equivalent years of education and experience.
• Direct industry experience in biologics drug product development.

Required Experience and Skills

• Hands‑on experience in formulation development for recombinant proteins, including antibodies, ADCs, and fusion proteins.
• Experience developing stable, high‑concentration liquid formulations and dosage forms for biologics.
• Experience developing aseptic fill‑finish manufacturing processes for biologic drug products in vial, pre‑filled syringe, and cartridge formats.
• Experience using analytical techniques to characterize physical and chemical properties of biologics.
• Knowledge of cGMPs and regulatory guidelines for biologics.
• Familiarity with biologics upstream and downstream processes.
• Strong data analysis, technical writing, and scientific communication skills.

6 months with the chance to extend.

Pay Range

$55/hr - $60/hr

Shift/Hours

Monday - Friday