Manufacturing Associate

Title: Manufacturing Associate

Location: Exton, PA

Full Time

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China.  Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary:

Frontage Laboratories Inc. is hiring Manufacturing Associate. The Manufacturing Associate will support GMP manufacturing operations, perform hands‑on production activities, assist in facility and equipment setup, and ensure compliance with cGMP standards. Responsibilities include executing GMP manufacturing of drug products, documenting activities, maintaining equipment cleanliness, and supporting raw material handling.

Roles & Responsibilities:

• Perform manufacturing tasks according to SOPs and cGMP requirements, including production of Sterile and non-sterile formulations.
• Take samples and perform in-process tests as required.
• Record all manufacturing, qualification, cleaning, and maintenance activities in logbooks following approved documentation practices.
• Assist in drafting SOPs, qualification protocols, and additional GMP documentation.
• Clean and disinfect GMP cleanrooms and manufacturing equipment to meet cleaning requirements.
• Perform equipment maintenance, calibration, conditioning, and troubleshooting.
• Gown into classified cleanroom environments and follow aseptic handling procedures when necessary.
• Maintain and monitor inventory of equipment and supplies.
• Handle hazardous and nonhazardous materials according to safety guidelines.
• Participate in process improvement, cost reduction, and new product development projects.
• Perform other duties as assigned to support manufacturing and facility operations
• Other duties assigned by Supervisor/Manager.
• Follow company policies and conduct work according to appropriate Frontage SOPs and comply with cGMP guidelines.

Education, Experience & Skills Required:

• Associate/Bachelor’s degree or equivalent preferred. 
• 1-2 years’ relevant experience.
• Experience in a regulated pharma/biotech environment with cGMP guidelines, cleanroom operations, equipment qualification, and cleaning procedures.
• Experience in aseptic cleanroom operations, buffer formulation, or sterile environments is a plus.
• Ability to wear PPE including respirators or dust masks.
• Good verbal and written communication skills.
• Ability to work independently and follow instructions accurately.
• Must be physically capable of lifting heavy objects and performing tasks that require prolonged standing, walking, bending, and reaching.

Salary and Benefits:

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

.