FORMULATION SCIENTIST

Responsibilities

• Evaluate and optimize critical process parameters (CPPs) and critical material attributes (CMAs) to ensure robust product performance, manufacturability, scalability, and stability.
• Design, execute, analyze, and document formulation and process development studies using scientific and risk-based approaches.
• Apply Quality by Design (QbD) and Design of Experiments (DoE) principles during product and process development activities.
• Support technology transfer, engineering batches, exhibit/registration batches, pilot-scale activities, and GMP manufacturing operations.
• Generate and review technical documentation, including: Experimental protocols, technical reports, Development summaries, Master Batch Records (MBRs), Formula cards, Scale-up and stability documentation.
• Perform hands-on laboratory and pilot-scale formulation activities (approximately 50-70% bench/lab work depending on project needs).
• Conduct physical characterization and evaluation of formulations and intermediates, including: Viscosity/rheology, Appearance and physical stability, Hardness/penetration testing, Melting behavior, Homogeneity and content uniformity, Dispersion/suspension characteristics.
• Operate and troubleshoot formulation and characterization equipment, including: Viscometers, Rheometers, Penetrometers, Homogenizers, Suppository testing equipment, and Vertical Franz diffusion cells (IVRT/IVPT).
• Collaborate cross-functionally with Analytical Sciences, Quality Assurance, Manufacturing, Regulatory Affairs, Purchasing, and Project Management teams to ensure successful project execution.
• Absorb and implement raw material selection, qualification, and procurement activities.
• Support evaluation, selection, and implementation of new laboratory and manufacturing equipment.
• Participate in manufacturing investigations, troubleshooting activities, process improvements, deviations, and CAPA-related support as needed.
• Ensure all activities are conducted in compliance with: Current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Data integrity requirements, and Internal quality systems and safety procedures.
• Effectively manage multiple projects and priorities within aggressive timelines while maintaining high technical quality and attention to detail.
• Perform other related duties as assigned.

Qualifications

• Education & Experience: M.S. in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline required; Ph.D. preferred.
• Minimum 5 years of pharmaceutical industry experience in formulation development, scale-up, and manufacturing support of drug products; equivalent combination of education and experience may be considered.
• Strong hands-on experience with semi-solid and liquid dosage forms is required, preferably including suppositories/pessaries and topical dosage forms.
• Experience supporting process scale-up, technology transfer, engineering batches, and GMP manufacturing activities.
• Strong understanding of pharmaceutical formulation principles, excipient functionality, and process development.
• Working knowledge of: QbD concepts, Design of Experiments (DoE), Pharmaceutical development best practices, and cGMP and GDP requirements.
• Experience with formulation characterization techniques and laboratory instrumentation commonly used in semi-solid and liquid product development.
• Ability to independently organize, prioritize, and manage multiple concurrent projects with minimal supervision.
• Excellent technical writing, verbal communication, and problem-solving skills.
• Strong attention to detail and commitment to scientific rigor and compliance.
• Proficiency in Microsoft Office Suite.
• Flexibility to support evolving project timelines and occasional extended working hours as required.

Physical Requirements

• Able to regularly lift up to 25 pounds and navigate active construction or facility expansion sites as needed.