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Job type: Permanent

Discipline: Biochemistry, Biological Sciences, Pharmacology

Location: United States

Proclinical is currently recruiting for a Process Development Scientist with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

Oversee the implementation of a comprehensive drug substance process development program spanning preclinical through commercial launch, leveraging external development organizations.
Ensure that a stage-appropriate level of process and product knowledge is maintained throughout the development lifecycle.
Build the external network for SPPS.
Identify and evaluate technical and quality capabilities of prospective CROs and CMOs.
Lead tech transfer to cGMP facilities. Partner with CMOs to diagnose and remediate process upsets.
Partner with QA groups to support product impact assessments and establish CAPAs.
Ensure CMO readiness for process validation, pre-approval inspection, and commercial launch of cGMP SPPS manufacturing processes.
Provide on-site technical support for process validation and pre-approval inspection, and as needed at earlier stages of development.
Provide expert technical insights supporting preparation of regulatory submission documents and responses to health authority queries.

Skills and Requirements:

B.S. organic chemistry with minimum 5 years of experience in the biopharma industry
Ability to remotely manage the design, development, and scale-up of SPPS at third parties.
Strong understanding of cGMPs and regulatory guidance pertaining to synthetic peptides.
Strong understanding of Quality by Design (QbD) principles of process design.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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