R&D Principal Scientist III

Job Description

R&D Sr. Principal Scientist III will serve as technical lead/subject matter expert to support commercialization of soft-shell gelatin and gummy products. They will be responsible for scale up of new products, lead investigations on any bulk or product issues during product lifecycle, develop strategies to improve current manufacturing technologies, and develop new strategies for future gummy manufacturing. They will be responsible for performing key development activities including authoring documentation, performing extended testing on pivotal batches, and training and troubleshooting were needed.

In addition, this candidate must be able to review applicable test methods and use scientific rationale when investigating any out of specifications related to bulk manufacture. They must be able to generate new scientific proposals and lead efforts to investigate, identify, develop, and optimize new and existing formulations. The candidate must have launched commercial supplement soft gel products.

Responsibilities

• Leads and oversees full scale pivotal development batches completing all documentation in a timely manner with appropriate scientific rationale and justification where needed.
• Trouble shoot existing methods and make appropriate timely recommendations on method development improvements.
• Works closely with Quality and R&D colleagues to prepare, review master batch records, work instructions, specifications, position papers, CAPAs, MRBs and SOPs as needed.
• Write reports to capture all key data and rationale to validate manufacturing process for new products.
• Periodically prepares research reports and technical recommendations by collecting, analyzing, and summarizing information and trends; gives presentations for both internal and external customers.
• Attend seminars and workshops to expand knowledge of new technologies and practices related to soft gelatin encapsulation and related fields.
• Conducts scientific trials to support new raw sources and determine impact to product.
• Responsible as a technical task leader within his/her area of expertise on company project teams, communications with corporate customer and 3rd party labs or for specific assignments.
• Participate in establishing project goals and timeline for technical tasks and contribute to the generation of project-related documents and presentations.
• Follows safety guidelines and policies when performing duties in the laboratory or manufacturing.

Education and Experience:

• Graduate degree in food science formulation, chemistry, or pharmaceutics.
• 15+ years of experience developing soft gelatin encapsulated products.
• 5+ years of experience developing formulations for commercial gummy and/or confectionary dosage forms
• Six Sigma certification preferred
• Excellent knowledge and experiences related to cGMP and regulatory requirements for NSF, USP and similar certifications.
• Demonstrated good ability to resolve major technical challenges by effectively utilizing available information and technical expertise in soft gelatin manufacturing