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