Director of Formulation, Quality & Manufacturing

Director of Formulation, Quality & Manufacturing

Royal Labs | Full-Time | On-Site

Salary: $125,000 Annually

Position Overview

Royal Labs is seeking a highly experienced technical leader with an exceptional background in chemistry, formulation development, quality control, regulatory compliance, and manufacturing operations.

This senior-level position requires an accomplished professional who has previously held a comparable leadership role within a large, nationally recognized cosmetic, personal care, or OTC pharmaceutical manufacturing company.

The successful candidate will work directly with our Head Chemist, oversee compounding operations, and provide advanced technical expertise across formulation, manufacturing, quality assurance, and regulatory compliance.

This is not an entry-level or developmental position. We are seeking a proven industry professional who can immediately contribute extensive knowledge, sound technical judgment, and established manufacturing expertise to our organization.

Key Responsibilities

• Provide technical leadership and oversight of all compounding and batch manufacturing operations.
• Supervise compounders and ensure accurate, consistent, and efficient manufacturing processes.
• Serve as the primary technical counterpart and backup to the Head Chemist.
• Lead formulation development, reformulation, troubleshooting, scale-up, and process optimization.
• Oversee quality control practices, including raw material specifications, analytical testing, in-process controls, finished product testing, stability, and product release requirements.
• Provide expertise in quality assurance, GMP compliance, deviations, investigations, CAPA, and manufacturing documentation.
• Ensure manufacturing operations meet applicable FDA regulations and industry standards.
• Support regulatory compliance, inspections, audits, and technical documentation.
• Evaluate and improve manufacturing procedures, product quality, and operational efficiency.
• Independently resolve complex formulation, quality, and manufacturing challenges.

Required Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a closely related scientific discipline required. Advanced degree preferred.
• Minimum 10 years of progressive experience in cosmetic, personal care, and/or OTC pharmaceutical formulation and manufacturing.
• Minimum 5 years in a senior technical or manufacturing leadership position within a large, established national manufacturing organization.
• Demonstrated expertise in formulation chemistry, ingredient compatibility, product stability, manufacturing scale-up, and commercial production.
• Comprehensive understanding of QC/QA systems, including analytical testing, specifications, laboratory procedures, method validation, investigations, and product release.
• Advanced knowledge of FDA regulations, cGMP requirements, and applicable regulatory standards, including 21 CFR Parts 210 and 211.
• Proven experience supporting or leading FDA inspections, regulatory audits, and quality compliance initiatives.
• Extensive hands-on experience troubleshooting complex formulation and manufacturing challenges.
• Demonstrated success leading technical teams, improving manufacturing processes, and maintaining high quality standards.
• Exceptional technical judgment, attention to detail, problem-solving ability, and leadership skills.
• Ability to operate independently and immediately assume significant technical and operational responsibilities.

Preferred Qualifications

• Direct experience manufacturing FDA-regulated OTC products, including sunscreens, acne treatments, and skin protectants.
• Experience with cosmetic emulsions, lotions, creams, gels, liquids, and other personal care formulations.
• Experience managing formulation development through commercial-scale manufacturing.
• Previous responsibility for overseeing both manufacturing operations and quality control functions.

Compensation

Annual Salary: $125,000

Full-Time | On-Site

About Royal Labs

Royal Labs is an established manufacturer specializing in cosmetics, personal care products, and OTC pharmaceuticals.

We are seeking an exceptional industry professional who brings proven leadership, advanced technical expertise, and the ability to strengthen our existing formulation, manufacturing, and quality systems from day one.

Pay: $125,000.00 per year

Benefits:

• Paid time off

Work Location: In person