R&D Principal Scientist III - International Vitamin Corporation

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. The candidate has excellent communication skills to meet with customers and lead technical discussions. 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 should be certified in Six Sigma process and must have launched commercial supplement soft gel products. They must be knowledgeable of dietary supplement ingredients and excipient function. They must be able to calculate label claim for actives and determine appropriate overages. Having experience with process analytical technology is a plus. The candidate must be knowledgeable of cGMP and regulatory requirements and not debarred from activities related to food or drug manufacture (FDA). They must set an example by creating an open environment of mutual respect and honesty and by focusing on the facts and data. They must be comfortable with mentoring and supervising others. Preference will be given to those who also have extensive experience formulating and commercializing gummy and/or dosage forms.

Specific 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; conducts work requiring judgment in the evaluation, selection, adaptation and modification of standard techniques, processes and criteria; review and provide technical guidance to technical challenges encountered, particularly unusual or complex problems.

· 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.

· Attends seminars and workshops to expand knowledge of new technologies and practices related to soft gelatin encapsulation and related fields; communicate newly acquired knowledge to Team and Leadership for as necessary for continuous improvement, and other considerations.

· Conducts scientific trials to support new raw sources and determine impact to product.

· Develop strategies to effectively address project and company goals/needs; Collaborate with functional and technical experts to facilitate scientific achievement.

· 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; Demonstrate the ability to resolve key technical hurdles and questions by effectively utilizing available information and technical expertise.

· Participate in establishing project goals and timeline for technical tasks and contribute to the generation of project-related documents and presentations.

· Demonstrate the character of a science professional and a high degree of responsibility in maintaining scientific standards, cGMP compliance, and safe laboratory practices for self and reporting staff.

· Responsible for compliance with applicable corporate policies and procedures; Follows safety guidelines and policies when performing duties in the laboratory or manufacturing.

· Participates in dietary supplement related and science-based organizations, review industry updates, new guidance, new methods, etc. with these groups as the IVC representative.

· Maintains ethical and good character as an IVC employee representing highest level of standards at all times as cited in our employee handbook.

General Responsibilities

· Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation.

· Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work unless requested by management to fulfill a specific assigned duty to support manufacturing.

· Performs such individual assignments as management may direct.

· Other duties as assigned.

Education, Experience, and Licenses:

· Graduate degree in food science formulation, chemistry, or pharmaceutics.

· At least 15 years of experience developing soft gelatin encapsulated products.

· At least 5 years of experience developing formulations for commercial gummy and/or confectionary dosage forms

· Six Sigma certification preferred

Knowledge, Skills, and Abilities

· 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

· Excellent time management, leadership, and communication skills (both oral and written).

· Motivated leader for innovation and continuous improvements with colleagues, learns fast, grasps the "essence”, and can change course quickly as required

· Ability to build excellent relationships with quality and other colleagues; proactive and motivated for best-in-class timely task completions and team performances

International Vitamin Corporation (IVC) Is an Equal Opportunity Employer. Our organization remains steadfast in our commitment to fostering an inclusive and non-discriminatory work environment that welcomes individuals from all backgrounds. We firmly maintain the belief that every individual ought to be treated with respect and dignity, regardless of their race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, genetic information, or any other protected characteristic, as defined by the law. We pledge that all eligible job applicants shall receive an impartial and unbiased evaluation during the recruitment process, without any form of discrimination based on any of the protected class. Our dedication to promoting diversity and inclusivity remains unwavering, and we take immense pride in cultivating a workplace culture that values and celebrates differences. Our efforts towards creating an environment that is free from prejudice and discrimination are an integral part of our organizational philosophy, and we stand committed to upholding these principles.