Senior Formulation Scientist

Overview

Design, scale, and ensure compliance of dietary supplement formulations for manufacturing.

Key Responsibilities

• formulation design
• scale‑up
• bmr review
• mmr development
• pilot testing
• material testing

Tasks

-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. -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. -Mentor junior formulators and provide technical guidance on projects, fostering a culture of knowledge-sharing and professional development. -Document all formulation processes, test results, and technical specifications in accordance with company protocols and 21 CFR Part 111 recordkeeping requirements. -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. -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. -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. -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. -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. -Stay informed on emerging trends in nutritional science, ingredients, and manufacturing technologies to innovate product lines.

Requirements

• cgmp
• 21 cfr
• hplc
• bachelor's
• leadership
• scale-up

What You Bring

-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). -Familiarity with analytical techniques such as HPLC, spectroscopy, and sensory evaluation. -Proficiency in technical writing and data analysis software. -Strong leadership and problem-solving skills, coupled with exceptional attention to detail. -For candidates with a bachelor’s degree, a minimum of 5 years of relevant experience. -Proficiency in scaling methodologies, including mathematical modeling for formula conversions and hands-on experience with unit operations such as granulation, drying, and tableting. -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 formulating dietary supplements, with hands-on knowledge of powder drink mixes, protein powders, and capsules; experience with tablets is also preferred. -Advanced skills in sensory science and consumer testing protocols to refine production formulas for palatability and market acceptance. -Bachelor’s degree in food science, chemistry, or a related field. -Experience in a regulated manufacturing environment for nutraceuticals, foods, and dietary supplements, including leadership in compliance audits or product launches. -Strong understanding of manufacturing scale-up processes, including equipment operation and process optimization. -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.

People Also Searched For

Benefits

-Pay Rate: $110K - $115K Base USD Yearly

About Raise

-Born from the 65-year legacy of Ian Martin Group, this company rethinks staffing with tech-first, self-managed operations. -Operates globally with offices in the US, Canada, Ghana, India, and the Philippines, offering permanent placement, contract recruitment, payroll/EOR, RPO, and total talent management. -Skilled trades, technical, and industry-specific teams support clients across IT, energy, manufacturing, healthcare, transportation, and more. -Tech platform uses AI-driven insights and real-time scheduling to enhance hiring speed and candidate experience. -Employs a Teal-operating, self-managed model, empowering employees to drive agility and innovation.

Sector Specialisms