Gelatin, Lead Formulation Technician B-Shift Days

Thermo Fisher Scientific•High Point, NC

7d•Onsite

About The Position

As part of the Pharma Services Group (PSG), the High Point, NC site is a commercial manufacturing and development facility specializing in gelatin-based drug delivery dosage forms (softgels). Recognized as a Softgel Center of Excellence since 1996, the site provides development, scale-up, and commercial manufacturing using a variety of proprietary softgel technologies. As a Gelatin Lead, you will provide daily leadership and technical guidance to the gelatin production team to ensure the timely preparation of high-quality gelatin used in the encapsulation process. You will help maintain compliance with cGMP requirements, support continuous improvement initiatives, and promote a culture of safety, quality, and operational excellence while meeting production goals.

Requirements

High school diploma or equivalent required.
Minimum of 4 years of experience in pharmaceutical manufacturing, production, operations, or a related manufacturing environment.
Previous experience operating gelatin manufacturing or encapsulation equipment.
Demonstrated experience leading teams, coordinating production activities, or serving as a lead operator.
Strong knowledge of gelatin manufacturing processes, softgel production, cGMP regulations, SOPs, and Good Documentation Practices.
Excellent leadership, communication, problem-solving, and decision-making skills with the ability to motivate and develop team members.
Ability to prioritize multiple tasks, troubleshoot equipment and process issues, maintain production schedules, and collaborate effectively with Quality, Maintenance, Engineering, and Production teams.
Ability to stand and walk for extended periods throughout a 12-hour shift.
Frequently lift, push, pull, or move materials weighing up to 50 pounds with or without reasonable accommodation.
Ability to climb stairs, bend, stoop, kneel, and perform repetitive motions.
Must wear required Personal Protective Equipment (PPE), including hairnets, beard covers (if applicable), safety glasses, hearing protection, gloves, and steel-toe footwear.
Work in a manufacturing environment with exposure to heat, humidity, moving mechanical equipment, and food/pharmaceutical-grade raw materials while maintaining strict cGMP, safety, and cleanliness standards.

Nice To Haves

Associate degree or technical education in Manufacturing, Engineering Technology, Industrial Technology, or a related field preferred.
Experience working in a cGMP-regulated pharmaceutical manufacturing environment.
Experience with SAP, electronic batch records, or manufacturing execution systems.
Experience training and mentoring production personnel.

Responsibilities

Lead and coordinate daily gelatin manufacturing activities, including weighing raw materials, loading gelatin silos, mixing Gel Manufacturing Records (GMRs), monitoring temperatures, and ensuring gel quality for encapsulation.
Train, coach, and support team members on Standard Operating Procedures (SOPs), cGMP requirements, safety practices, Automated Gelatin Manufacturing System (AGMS) operations, and Good Documentation Practices (GDP).
Monitor production schedules, troubleshoot process or equipment issues, complete production documentation, communicate with supervisors and cross-functional teams, and ensure equipment cleaning and changeovers are completed according to validated procedures.