FORMULATION SCIENTIST

LGM Pharma, LLC•Rosenberg, TX

2d•$87,500 - $105,000•Onsite

About The Position

The Formulation Scientist will lead formulation development, optimization, and scale-up activities for semi-solid and liquid pharmaceutical dosage forms. This role involves evaluating and optimizing critical process parameters and material attributes to ensure robust product performance, manufacturability, scalability, and stability. The scientist will apply Quality by Design (QbD) and Design of Experiments (DoE) principles, support technology transfer and GMP manufacturing, and generate technical documentation. A significant portion of the role involves hands-on laboratory and pilot-scale formulation activities, including physical characterization and equipment operation. Collaboration with cross-functional teams and participation in manufacturing investigations are also key aspects of this position. All activities must be conducted in compliance with cGMP, GDP, and internal quality and safety procedures. The role requires effective management of multiple projects within aggressive timelines.

Requirements

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.

Responsibilities

Lead formulation development, optimization, and scale-up activities for semi-solid and liquid pharmaceutical dosage forms, including: (Rectal and vaginal suppositories/pessaries, Creams, gels, ointments, lotions, and topical foams, and Oral and topical liquid formulations)
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.
Assist in 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.