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:

• Research, develop and execute all activities relating to the manufacturing/packing of various pharmaceutical dosage forms by performing scientific analysis/lab testing/validations etc. while working under the supervision of Sr. Manufacturing Scientist/Manager.
• Follow guidance to review and perform execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of production equipment to meet validation and regulatory requirements. Will perform installation and operation qualifications for all injectable equipment.
• Conduct qualification and performance verification of dry powder injectable facilities and equipment as instructed.
• Assist Sr. Scientists/Manufacturing Manager to plan and execute batch dispensing and manufacturing activities. Will compile scientific/technical documentation involved in execution of commercial & validation batches & draft documents for regulatory aduits, ANDA submissions to US FDA and cGMP documentation with reference to manufacturing department.
• Follow established guidelines/plans to ensure effective implementation of quality management system (QMS) as per CGMP and regulatory requirements at all levels of manufacturing by collecting/researching/analyzing scientific data/reports, recording scientific evidence/results from development/manufacturing activities etc.
• Draft manufacturing department SOPs for manager’s review and approval.
• Approximately 85% of the time will be spent in researching, developing, improving, executing and validating all scientific and technical activities relating to the manufacture/packing of various pharmaceutical dosage forms — all under close supervision and guidance from our manufacturing manager and our senior/experienced chemists/scientists. Approximately 15% of the time will involve researching and preparing scientific/technical reports, regulatory guidance and in coordinating/interacting with scientists.

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.