Chemist (Manufacturing Associate)
Penn Life Sciences is seeking a skilled Chemist (Manufacturing Associate) to join our team in Langhorne, PA.
The Chemist (Manufacturing Associate) serves as a key manufacturing-facing technical resource, supporting investigations, documentation, and continued process verification to ensure consistent product quality and compliance with cGMP and regulatory requirements. The ideal candidate will bring hands-on experience in sterile manufacturing support, validation activities, and cross-functional collaboration within a regulated pharmaceutical environment.
This position’s responsibilities will include, but not be limited to the following:
- Provide on-floor technical support to sterile manufacturing operations during routine production, validation, and qualification activities.
- Prepare, execute, and support the review of manufacturing-related validation documentation, including IQ, OQ, PQ, process validation, and continued process verification activities.
- Support deviation investigations, root cause analyses, and CAPA development related to manufacturing, validation, or qualification activities.
- Evaluate manufacturing changes and support change control activities related to processes, equipment, facilities, utilities, and procedures.
- Collaborate cross-functionally with Quality, Validation, Engineering, and Technical Services to ensure alignment across manufacturing activities.
- Support regulatory inspections, audits, and internal assessments related to manufacturing and validation activities.
We are looking for applicants with:
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a closely related scientific discipline required; Master’s degree preferred.
- 2–5 years of experience supporting pharmaceutical manufacturing, validation, or technical operations in a cGMP-regulated environment.
- Prior experience in sterile or aseptic manufacturing environments strongly preferred.
- Working knowledge of cGMP requirements (21 CFR Parts 210/211) and experience supporting validation and continued process verification activities.
- Strong technical writing, documentation review, and cross-functional communication skills.
What we offer:
- 401(k) with company match
- Health, vision, and dental Insurance
- Childcare expense reimbursement
- Tuition reimbursement
- Annual bonus eligibility
- Annual merit increases
- Paid Time Off and Flexible Holidays
Penn Life Sciences is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.
We encourage you to apply if you feel that you are a match! We look forward to hearing from you.