Position SummaryThe Senior Formulation/Process Scientist is a senior-level, hands-on individual contributor responsible for pharmaceutical formulation and process development, experimental execution, scale-up, troubleshooting, and technology transfer. Working under the direction of the Director of Research and Development, this position translates project objectives into scientifically sound experimental plans and personally executes laboratory and pilot-scale studies. The role supports liquid, suppository/pessary, and semi-solid products for cosmetic, 510(k), ANDA, and NDA programs, as applicable.
This position requires a strong and consistent presence in the laboratory and pilot plant environment. This is a senior individual-contributor role focused on hands-on experimentation, data interpretation, process development, scale-up, troubleshooting, and successful technical execution. Overall R&D strategy, personnel management, resource allocation, and final project decisions remain the responsibility of the Director of Research and Development.
RESPONSIBILITIES:- Design and personally execute formulation and process-development experiments.
- Develop and optimize liquid, suppository/pessary, and semi-solid formulations.
- Evaluate API and excipient properties, compatibility, formulation robustness, and product performance.
- Generate, analyze, and interpret reliable experimental data and recommend scientifically justified next steps.
- Apply Quality by Design (QbD) and Design of Experiments (DOE) principles, as appropriate.
- Identify and evaluate Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
- Perform process optimization, characterization, scale-up, and technology-transfer activities.
- Translate laboratory processes to pilot and commercial manufacturing scales.
- Evaluate process variables such as mixing, shear, homogenization, temperature, order of addition, processing time, hold time, transfer, and filling.
- Troubleshoot formulation, process, scale-up, and manufacturing issues using experimentation and root-cause analysis.
- Provide hands-on technical support during pilot, engineering, scale-up, technology-transfer, and manufacturing activities.
- Collaborate with Manufacturing, Engineering, Analytical, Quality, Regulatory, and Project Management teams to resolve technical issues.
- Maintain accurate laboratory notebooks, protocols, experimental records, and development reports.
- Operate appropriate laboratory and pilot-scale processing equipment.
- Serve as a senior technical resource and mentor scientists and technicians without formal personnel-management responsibility.
- Manage multiple assignments and take ownership of the quality and timely completion of assigned work.
- Perform other duties as assigned.
QUALIFICATIONS:- Doctorate in Pharmaceutical Sciences, Pharmaceutical Engineering, Chemical Engineering, or a related discipline required.
- Minimum of seven years of relevant pharmaceutical-development experience or an equivalent combination of education and experience.
- Demonstrated hands-on experience in formulation, process development, and laboratory-to-pilot or commercial scale-up required.
- Experience with liquid, suppository/pessary, and/or semi-solid dosage forms strongly preferred.
- Experience supporting cosmetic, 510(k), ANDA, and/or NDA programs preferred.
- Experience with technology transfer, engineering batches, process characterization, and manufacturing troubleshooting preferred.
- CDMO or other fast-paced, multi-project pharmaceutical-development experience preferred.
- Advanced knowledge of pharmaceutical formulation, process development, scale-up, CQAs, CPPs, QbD, DOE, and process robustness.
- Strong hands-on laboratory, experimental-design, data-analysis, and troubleshooting skills.
- Ability to independently execute complex technical assignments and translate laboratory findings into practical manufacturing recommendations.
- Strong scientific judgment, problem-solving, documentation, and communication skills.
- Ability to manage multiple priorities and collaborate effectively in a cross-functional environment.
