Biologics Drug Product Process Development Scientist (Contract)

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:

• Masters 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

$55/hr. - $60/hr.

Monday - Friday

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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