Job Description
Job Description
Senior Formulation Scientist
Position Overview
We are seeking a skilled Senior Formulation Scientist to join our team in developing innovative nutritional products. The ideal candidate will possess expertise in formula creation and scaling for manufacturing, with a focus on delivering high-quality dietary supplements and powdered conventional foods that meet regulatory standards and consumer needs. This role requires a background in food science or chemistry and involves collaboration with cross-functional teams to ensure product efficacy, safety, and manufacturability.
Key Responsibilities
- Design and develop formulations for dietary supplements, including powder drink mixes, protein powders, capsules, and tablets.
- Oversee scale-up processes from laboratory prototypes to full-scale manufacturing, optimizing for efficiency, stability, and cost-effectiveness.
- Conduct detailed scaling calculations and adjustments to convert conceptual formulas (e.g., from paper or lab notes) into production-scale formulas, accounting for factors such as ingredient interactions, equipment limitations, and yield optimization.
- Perform feasibility assessments and pilot runs to validate production formulas, identifying potential issues like clumping in powders or stability in capsules during large-scale mixing or encapsulation.
- Develop and revise Master Manufacturing Records (MMR) as templates for consistent production processes, ensuring they include precise instructions for ingredient weighing, blending sequences, and quality checkpoints in compliance with 21 CFR Part 11.
- Review and approve Batch Manufacturing Records (BMR) for each production run, verifying adherence to MMR standards, documenting deviations, and facilitating root-cause analysis for any discrepancies, in accordance with 21 CFR Part 111 requirements for production and process controls.
- Coordinate with supply chain teams to align production formulas with raw material specifications, ensuring scalability while minimizing waste and maintaining product integrity.
- Collaborate with Quality Assurance, Production, and Regulatory teams as a crucial member of the Material Review Board (MRB), to troubleshoot formulation hurdles and implement improvements.
- Ensure raw materials meet specification standards, including quality testing for nutritional value, bioavailability, and sensory attributes, as required under 21 CFR Part 111 for components and in-process materials.
- Document all formulation processes, test results, and technical specifications in accordance with company protocols and 21 CFR Part 111 recordkeeping requirements.
- Mentor junior formulators and provide technical guidance on projects, fostering a culture of knowledge-sharing and professional development.
- Stay informed on emerging trends in nutritional science, ingredients, and manufacturing technologies to innovate product lines.
Required Qualifications
- Bachelor’s degree in food science, chemistry, or a related field.
- For candidates with a bachelor’s degree, a minimum of 5 years of relevant experience.
- Strong understanding of manufacturing scale-up processes, including equipment operation and process optimization.
- Proficiency in scaling methodologies, including mathematical modeling for formula conversions and hands-on experience with unit operations such as granulation, drying, and tableting.
- In-depth knowledge of current Good Manufacturing Practices (cGMP) and regulatory documentation requirements under 21 CFR Part 111, including the creation and auditing of BMR and MMR for dietary supplements.
- Proven experience in formulating dietary supplements, with hands-on knowledge of powder drink mixes, protein powders, and capsules; experience with tablets is also preferred.
- Familiarity with analytical techniques such as HPLC, spectroscopy, and sensory evaluation.
- Strong leadership and problem-solving skills, coupled with exceptional attention to detail.
- Proficiency in technical writing and data analysis software.
Preferred Skills
- Experience in a regulated manufacturing environment for nutraceuticals, foods, and dietary supplements, including leadership in compliance audits or product launches.
- Advanced knowledge of natural ingredients, flavor masking, encapsulation technologies, and sustainable sourcing practices.
- Demonstrated ability to lead cross-functional teams and manage multiple projects simultaneously in a fast-paced setting.
- Proven experience in auditing and validating Batch Manufacturing Records (BMR) and Master Manufacturing Records (MMR) to ensure compliance with US cGMP standards under 21 CFR Part 111 (mandatory) and international standards like ISO 22000 or NSF/ANSI 455 (preferred).
- Advanced skills in sensory science and consumer testing protocols to refine production formulas for palatability and market acceptance.
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