Position Summary
The 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.
At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision, and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.