Formulation Technical Service Specialist

1 week ago

Copiague, NY, United States ClinLab Solutions Group Full time

SUMMARY:

The Formulation Technical Service Specialist is a subject-matter expert responsible for advanced formulation support, manufacturing troubleshooting, scale-up, and process optimization in gummy and confectionery dietary supplement production. This role bridges R&D, Quality, and Operations by ensuring robust formulations, efficient production performance, adherence to GMP standards, and successful commercialization of new and existing gummy products. The Senior Specialist will also mentor technical staff and support cross-functional project initiatives.

Work Schedule: Monday - Friday 8am-4:30pm

JOB QUALIFICATIONS:

  • Masters of Science degree in Pharmacy, Chemistry or a pharmaceutical-related science.
  • 5 + years experience directly related to confectionary formulation development, scale-up and manufacturing of dietary supplements or equivalent combination of education and experience.
  • Experienced in the use of Design of Experiments concepts when developing new formulations.
  • Preferred experience with confectionary and solid dosage forms including sustained and delayed release.
  • Requires good knowledge of GMP related to pharmaceutical manufacturing.
  • Strong communication skills, both written and verbal.
  • Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
  • Self motivated with the ability to work under pressure to meet deadlines.
  • Able to travel as needed.

POSITION RESPONSIBILITIES:

Formulation, Scale-Up & Tech Transfer

  • Optimize existing gummy formulations and improve their manufacturing processes for consistency, quality, and efficiency.
  • Lead scale-up and technology transfer of new gummy and confectionery products from R&D to full-scale manufacturing.
  • Utilize Design of Experiments (DoE) and statistical methods to develop and refine formulations.
  • Conduct literature reviews, including publications and patents, to support innovation and problem-solving.
  • Review and analyze analytical data, ingredient specifications, and test results generated by laboratory and production teams.
  • Generate technical protocols, development reports, master batch records, and other GMP-compliant documentation.
  • Work with Customer Service or Commercial teams to support product costing, quoting, and feasibility assessments.

Technical Troubleshooting & On-Floor Support

  • Serve as the primary technical resource for on-the-floor troubleshooting of gummy production issues such as texture deviations, sticking, bloom, air entrapment, yield loss, or actives instability.
  • Investigate and resolve manufacturing deviations and collaborate with QA to support CAPAs and root cause analysis.
  • Provide hands-on support for cooking, depositing, conditioning, de-molding, and packaging steps.
  • Guide continuous improvement initiatives to enhance throughput, reduce waste, and improve process reliability.

Process & Equipment Expertise

  • Support manufacturing equipment operations including kettles, vacuum cookers, depositors, mogul systems, and starchless molding technologies.
  • Assist with equipment commissioning, optimization, and process validation activities.
  • Ensure all manufacturing processes meet cGMP, HACCP, and applicable regulatory requirements.

Leadership & Cross-Functional Collaboration

  • Provide direction, mentorship, and technical oversight to assigned scientists, technologists, and technicians.
  • Communicate effectively with R&D, Quality, Operations, Engineering, and Commercial teams on technical issues and project progress.
  • Lead or participate in cross-functional teams focused on new product development, process improvement, and troubleshooting.

PHYSICAL REQUIREMENTS:

  • Primarily on-site in a gummy or confectionery manufacturing environment with exposure to production equipment, varying temperatures, and ingredient handling.
  • Adhere to strict safety protocols, including wearing personal protective equipment.

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