Senior Formulation Scientist
Employer undisclosedRole managed by a recruiter
Develop and scale dietary supplement formulations, ensuring cGMP compliance.
21 days ago ago
$110,000 - $115,000
Expert & Leadership (13+ years), Experienced (8-12 years)
Full Time
Richardson, TX
Office Full-Time
Role
What you would be doing
scale-up
formulation design
process documentation
material review
supply chain
regulatory compliance
- Oversee scale-up processes from laboratory prototypes to full-scale manufacturing, optimizing for efficiency, stability, and cost-effectiveness.
- Coordinate with supply chain teams to align production formulas with raw material specifications, ensuring scalability while minimizing waste and maintaining product integrity.
- 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.
- 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.
- 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.
- Stay informed on emerging trends in nutritional science, ingredients, and manufacturing technologies to innovate product lines.
- 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.
- Design and develop formulations for dietary supplements, including powder drink mixes, protein powders, capsules, and tablets.
- 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.
What you bring
cgmp
scale-up
hplc
sensory
food science
leadership
- Proficiency in technical writing and data analysis software.
- 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.
- Advanced knowledge of natural ingredients, flavor masking, encapsulation technologies, and sustainable sourcing practices.
- For candidates with a bachelor’s degree, a minimum of 5 years of relevant experience.
- Bachelor’s degree in food science, chemistry, or a related field.
- Strong understanding of manufacturing scale-up processes, including equipment operation and process optimization.
- 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).
- Demonstrated ability to lead cross-functional teams and manage multiple projects simultaneously in a fast-paced setting.
- Experience in a regulated manufacturing environment for nutraceuticals, foods, and dietary supplements, including leadership in compliance audits or product launches.
- Familiarity with analytical techniques such as HPLC, spectroscopy, and sensory evaluation.
- Proven experience in formulating dietary supplements, with hands-on knowledge of powder drink mixes, protein powders, and capsules; experience with tablets is also preferred.
- Strong leadership and problem-solving skills, coupled with exceptional attention to detail.
- Proficiency in scaling methodologies, including mathematical modeling for formula conversions and hands-on experience with unit operations such as granulation, drying, and tableting.
- Advanced skills in sensory science and consumer testing protocols to refine production formulas for palatability and market acceptance.
- Pay Rate: $110K - $115K Base USD Yearly
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Interview process
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