Biologics Drug Product Process Development Scientist (Contract)

Atrium Works • Boston, MA

1d • Onsite

About The Position

Vertex is seeking a 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.

Requirements

• 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.
• 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

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 documentaiton to support development activities and technology transfer.
• Perform wet-lab activities as needed to support program objectives.

Benefits

• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level