JOB SUMMARY:

We are currently searching for a highly motivated and innovative Formulation Scientist to join the Formulation/Process Development team. In this role, you will be responsible for leading projects focused on formulation design, development, scale-up.

This role will involve hands-on laboratory work as well as mentoring and training junior scientists. All duties will be performed in compliance with standard operating procedures (SOPs). Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies and procedures, Current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Global Food Safety Initiatives (GFSI).

ESSENTIAL FUNCTIONS (other duties as required):

• · Independently design and develops formulations dietary supplement formulations based on scientific principles, market trends, and customer needs, with targeting modalities for innovative products.
• · Ensure successful scale up of formulation production from bench scale to larger scale manufacturing.
• · Provides technical guidance internally to the analytical and manufacturing teams on the formulation methodologies and issues.
• · Leads investigations of aberrant results, determination of root causes and recommends action plan.
• · Stay informed about relevant regulations, ensuring that all formulations comply with industry standards, FDA guidelines, and other applicable regulations.
• · Work closely with VP of regulatory affairs to facilitate product registrations and approvals.
• · Demonstrate creativity and independence in developing, optimizing, and advancing process platform for formulations.
• · Run formulation support for stability and evaluation studies for various projects.
• · Develop and/or contribute to development of analytical methods for physico-chemical characterization of product.
• · Prepares scientific reports, technical reports, presentations and experimental protocols as needed.
• · Work in collaborate with manufacturing teams to scale up formulations for mass production.
• · Represent formulation development function in various project team meetings and contribute to overall project goals and deliverables.
• · Contribute to formulations/process development for new product.
• · Review scientific literature, patents, scientific abstracts to stay up to date on latest in the field.
  
• · Participate in Performance Improvement and safety initiatives, including job related and annual training(s), i.e., cGMP, SQF.

Supports Good Manufacturing Principles (cGMP) and Global Food Safety Initiatives (GFSI) certification by the following (but not limited too):

• Adherence to cGMP and Safe Quality Food (SQF) practices, standard operating methods, and legal regulations to maintain a safe and clean work environment.
• Document all production efforts in appropriate logs, forms, reports, and databases.
• Ensure the required quality and safety standards are achieved and maintained with respect to cGMP and SQF operating procedures, all documentation, area housekeeping, production suites, and compliance with the relevant regulatory and legislative requirements.
• Working and partnering with other groups for requirements relating to quality systems, safety, equipment maintenance, and warehousing for cGMP and SQF initiatives.
• Maintains appropriate employee hygiene and cleanliness.

COMPETENCIES:

• · Must be able to maintain high degree of confidentiality. Ability to multi-task, work efficiently in a fast-paced environment and manage time accordingly in order to meet deadlines and requirements of the organization.
• Excellent interpersonal communication skills including presentation skills and multitask ability.
• Must have strong computer skills, knowledgeable with standard Microsoft Office suite, email, document scanning, and strong Excel and Word experience.
• Must have the ability to work in a fast-paced environment.
• Strong attention to detail.
• Ability to apply mathematical operations to such tasks as determination of test reliability and validity, analysis of variance, etc.

 

WORK ENVIRONMENT:

The work characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Fast-paced, deadline oriented, confidential department. The noise level in the work environment is usually moderate to noisy.




POSITION TYPE AND EXPECTED HOURS OF WORK:

• Full-time 40-hour work week with the ability to work a flexible schedule, including nights and weekends.

   

  TRAVEL REQUIRED:

  • Some travel will be required

     

    REQUIRED EDUCATION AND EXPERIENCE:
  • B.S./M.S. degree and 3+ years’ experience in formulation development in the dietary supplement or pharmaceutical industry or equivalent experience
  • Experience with process development, engineering and manufacturing are highly desired.
  • Expertise and knowledge in process development, scale up of formulation production and purification unit operations and tech transfer activities.
  • Demonstrated ability to establish new capabilities and innovate strategies in pursuit of scientific excellence. Must be an independent thinker with a passion for developing innovative formulation technologies.
  • Familiarity with regulatory requirements for dietary supplements.
  • Excellent communication and collaboration skills to work effectively in cross-functional teams.
  • Must possess in depth understanding of all aspects of formulation development as well as downstream characterization including physicochemical, stability and biological evaluation.
  • Comfortable working in a highly innovative, changing, fast-paced environment with multi-task skills is required.
  • Strong analytical and problem-solving skills. Details oriented with good organization skills, great troubleshooting skills, team player, excellent oral and written communication skills are necessary for this position.
  • BA/BS degree in Nutrition/Dietetics, Food Science, Chemistry, Microbiology, or related field
  • 1+ years’ experience in microbiome-related product development and 3+ years’ experience in supplement formulation with variable dosage types. Will accept any suitable combination of education, training, or experience as per the requirements cited herein.