Scientist - Formulation R&D

Research and Development/Analytical and Formulary Allegan, Michigan


Descripción

Candidates must have hands-on, and applied work experience with solid / liquid oral dosage Dietary Supplements, Nutraceutical and Probiotics formulations to receive consideration for this role.  

Key responsibilities include: 

  • Interfacing with Analytical Research & Development scientists, Technical Operations, RA, QA and Marketing to facilitate “First-to-Market” corporate goals.
  • Lead the formulation development of new dietary supplements (i.e., vitamin, mineral, herbs and supplements (VMHS)), nutraceuticals, probiotics and botanicals sourced dosage forms that connect to consumers to deliver targeted benefits focused on overall wellness, and immune boosters among others.
  • Demonstrate subject matter expertise in Structure and Function and Health claims development and substantiation.
  • Interpret and implement customer requests into formulation prototypes, such as great-tasting and sensory attributes to achieve consumer sensory acceptance.
  • Experience in probiotics systems formulations in dietary supplements, or pharmaceuticals in different oral dosage forms.
  • Acts as internal/external Subject Matter Expert (SME) for new dietary supplements, nutraceuticals, probiotics and botanicals sourced product and process related technical issues and provides technical support to Technical Operations, Manufacturing, Quality and to third party contractors.
  • Partners with marketing and internal consumer research teams to design and coordinate consumer research studies to optimize product design and assure new products deliver an exceptional consumer experience.
  • Lead the manufacture of Pivotal/Registration batches for new products in the Product/Process Development Pilot Plant and Manufacturing facilities.
  • Design and perform quality scientific experimentation to develop robust processes in support of Formulation / Process Development activities.
  • Proactively identify and lead technical team evaluation of novel functional ingredients, delivery forms, process and other relevant technologies to fuel future innovation.
  • Contribute to the development of new experimental approaches. Analyze and defend scientific results from experiments.
  • Generate accurate, reliable data by following established procedures and practices to support product development. Record, tabulate, summarize, interpret, report and publish results. Prepare Master Batch Records for Experimental, Pilot/Pivotal, scale-up and process validation batches.
  • Perform effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects.
  • Communicates effectively to project manager and the wider development team and presents data at team meetings and departmental technical meetings.
  • Leads and/or Collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits.
  • Ensure understanding and compliance with dietary supplements GMPs in the DSHEA (Dietary Supplement Health and Education Act of 1994), current Drug Enforcement Administration (DEA), current Good Manufacturing Practices (cGMP), certifications (non-GMO, Kosher, Halal, DSVP, etc.), Perrigo policies and Quality Systems, and all applicable regulatory agencies.   

Requirements:  

  • Knowledge of the principals and practices of dietary supplements (i.e., vitamin, mineral, herbs and supplements (VMHS)), nutraceuticals, probiotics and botanicals sciences and pharmaceutical sciences combined with professional experience in developing and testing formulation processes in more than one dosage form or product category.
  • Proven track record of successful delivery of technical projects in a value-added consumer packaged goods environment preferred.
  • Expert with QbD principles.
  • Expert in writing parts of New Dietary Ingredient (NDI) submissions and NDA/ANDA submissions relevant to the formulation / process development for regulatory filing to the US Food & Drug Administration.
  • Sound problem solving skills and good scientific judgment are required.
  • Good communication skills and the ability to work on interdisciplinary teams are required.
  • Hands on small-scale equipment and good understanding of large scale conventional pharmaceutical equipment is required.
  • Familiarity with project management methodology is necessary.
  • Perform effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects.
  • Ensure compliance of all formulation activities to applicable cGMPs, cGLPs, any specific regulatory guideline, and company SOPs on a consistent basis.  Conduct routine laboratory audits and involvement in activities associated with third party laboratory audits, as required.  

Knowledge, Experience and Education Qualifications: 

  • Bachelor’s Degree in Pharmaceutical Sciences, Chemical Engineering, Food Science, Nutritional Sciences or closely allied life sciences discipline with 5 to 8 years of relevant dietary supplements, nutraceutical and probiotics development experience -- or
  • Master’s Degree in Pharmaceutical Sciences, Chemical Engineering, Food Science, Nutritional Sciences, Pharmacognosy (or closely allied life sciences discipline developing medicinal drugs or dietary supplements from plants or other natural sources) with 3 to 6 years of relevant dietary supplements, nutraceutical and probiotics development experience – or
  • Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Food Science, Nutritional Sciences, Pharmacognosy (or closely allied life sciences discipline developing medicinal drugs or dietary supplements from plants or other natural sources) with 3 or more years of relevant dietary supplements, nutraceutical and probiotics development experience.
  • Leadership Knowledge, Skills and Abilities: (NOTE: This position does not directly supervise others).
  • Ability to align with clear goals, direction, motivation, clarity, and support needed for self and others to excel in a continuous improvement culture.
  • Ability to organize appropriately in an environment requiring strict adherence to timelines.
  • Use the appropriate amount of analysis, experience and judgement to make clear/concise decisions.
  • Good communication skills including strong verbal and interpersonal skills to lead and influence.

#DIV

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.