Biologics Drug Product Process Development Scientist (Contract)

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 76,000 - 83,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston seeks a Scientist to join the Process Development team to advance biologics drug products from formulation to scale-up and technology transfer to CDMOs for clinical pipelines.

The role focuses on formulation and primary container development, fill-finish process development, and transfer activities, with hands-on lab work and strong data analysis. This is an on-site, 6-month contract with potential extension at our Boston Seaport campus.

Qualifications

• Hands-on experience in formulation development for recombinant proteins (antibodies, ADCs, fusion proteins).
• Experience creating stable, high-concentration liquid formulations for biologics.
• Aseptic fill-finish processes for vial, pre-filled syringe, and cartridge formats.
• Proficient use of analytical techniques to characterize biologics.
• Knowledge of cGMPs and regulatory guidelines for biologics.
• Familiarity with biologics upstream and downstream processes.
• Strong data analysis and scientific writing skills.

Responsibilities

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

Skills

Formulation development for biologics

High-concentration liquid formulations

Aseptic fill-finish processes

Analytical characterization of biologs

Knowledge of cGMPs

Biologics upstream/downstream

Data analysis & science writing

Education

Master’s or PhD in Chemical/Biochemical Engineering or Pharmaceutical Sciences

3-5 years of industry experience (or PhD +1-2 years)

Job description

Job Description

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.

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 documentaiton 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

Contract Length: 6 months with the chance to extend

Pay Range

$55/hr. - $60/hr.

Shift/Hours

Monday - Friday