Job Description
Job Description
About the Role
The Process Development Scientist plays a critical role in optimizing manufacturing processes and scaling formulation technologies across liquids, creams, gummies, tablets, powders, capsules, and over-the-counter (OTC) products. This position ensures the seamless transfer of product formulations from research and development to full-scale production. Leveraging process engineering, formulation science, and continuous improvement methodologies, the engineer drives manufacturing efficiency, cost reduction, and regulatory compliance in a high-performance production environment.
Responsibilities:
- Design, develop, and optimize manufacturing processes for efficient scale-up and production readiness
- Conduct process characterization, workflow analysis, and equipment selection to improve production efficiency
- Lead technology transfer activities, ensuring robust scale-up of formulations for multiple dosage forms
- Analyze and enhance process workflows using Lean Manufacturing tools such as Value Stream Mapping and Kaizen
- Apply Six Sigma methodologies, including DMAIC and DMADV, to improve quality, yield, and consistency
- Develop and refine batch records, standard operating procedures (SOPs), and process validation documentation
- Perform or oversee IQ, OQ, and PQ validations to ensure process compliance and performance
- Support troubleshooting of production issues related to quality, yield, and throughput
- Draft and maintain manufacturing documentation including BOMs, routings, and operator instructions
- Collaborate cross-functionally with R&D, Quality Assurance, and Operations to align on product and process requirements
- Interface with vendors and suppliers to enhance equipment capability and raw material performance
- Present technical findings and process improvements to internal and external stakeholders
- Ensure compliance with GMP, FDA, NSF, ISO, and OSHA regulations across all manufacturing processes
Qualifications:
- Bachelors or masters degree in Chemical Engineering, Pharmaceutical Sciences, Food Science, Mechanical Engineering, or a related discipline
- Minimum of 5 years of experience in process development and formulation within nutraceutical, pharmaceutical, or cosmetics industries
- Proven expertise in scaling up and optimizing formulations for liquids, creams, tablets, powders, capsules, gummies, and OTC products
- Proficiency in process engineering equipment such as tablet presses, granulators, encapsulators, mixers, and gummy cookers
- Strong background in formulation science across solid, semi-solid, and liquid dosage forms
- Hands-on experience with technology transfer from R&D to manufacturing environments
- Skilled in process optimization, root cause analysis, and statistical tools including Minitab and FMEA
- Knowledge of regulatory frameworks including GMP, FDA, NSF, ISO, and OSHA
- Project management and problem-solving abilities in a fast-paced production setting
Desired Qualifications:
- Lean Six Sigma Green Belt or Black Belt certification
- Certification in GMP or FDA regulatory compliance
- Experience drafting design transfer documentation and validation protocols
- Familiarity with Design for Manufacturing (DFM) principles
- Experience leading cross-functional project teams in product commercialization initiatives
- Strong communication skills with the ability to convey technical information to diverse audiences