Highly Competitive Salary
  1. Permanent
  2. Biochemistry, Biological Sciences, Pharmacology
  3. United States
Philadelphia, USA
Posting date: 12 Jan 2021

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

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.