FORMULATION SCIENTIST

LGM Pharma; Rosenberg (TX); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K with company match

Job summary

LGM Pharma seeks an experienced Formulation Scientist to lead development, scale-up, and manufacturing support for semi-solid and liquid dosage forms in a fast-paced environment.

Responsibilities include implementing QbD/DoE, coordinating tech transfer, and ensuring cGMP/GDP compliance across R&D and manufacturing operations. Strong writing and collaboration skills are essential.

Qualifications

• M.S. in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related field required; Ph.D. preferred.
• Minimum 5 years of pharmaceutical industry experience in formulation development, scale-up, and manufacturing support; kombinational experience may be considered.
• Strong hands-on experience with semi-solid and liquid dosage forms, including suppositories/pessaries and topical 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.
• Knowledge of QbD concepts, DoE, and cGMP/GDP requirements.
• Experience with formulation characterization techniques and laboratory instrumentation.
• Ability to independently organize, prioritize, and manage multiple projects with minimal supervision.

Responsibilities

• Lead formulation development, optimization, and scale-up activities for semi-solid and liquid dosage forms.
• Evaluate CPPs and CMAs to ensure robust product performance, manufacturability, scalability, and stability.
• Design, execute, analyze, and document formulation and process development studies using risk-based approaches.
• Apply QbD and DoE principles during product and process development activities.
• Support technology transfer, engineering batches, GMP manufacturing operations, and pilot-scale activities.
• Generate and review protocols, technical reports, development summaries, MBRS, formula cards, and stability documentation.
• Perform hands-on lab and pilot-scale formulation work (50–70% bench work).
• Conduct physical characterization and evaluation of formulations (viscosity, stability, hardness, melting, homogeneity).
• Operate and troubleshoot equipment (viscometers, rheometers, penetrometers, homogenizers, diffusion cells).
• Collaborate cross-functionally with Analytics, QA, Manufacturing, Regulatory Affairs, Purchasing, and PM teams.
• Assist in raw material selection, qualification, and procurement.
• Support evaluation and implementation of new lab and manufacturing equipment.
• Participate in investigations, deviations, CAPA support.
• Ensure compliance with cGMP, GDP, data integrity, and safety procedures.
• Manage multiple projects within aggressive timelines with high technical quality.
• Perform other related duties as assigned.

Skills

Semi-solid & liquid dosage forms

Process scale-up & tech transfer

QbD & DoE

cGMP & GDP

Laboratory instrumentation

Technical writing

MS Office

Project management

Education

M.S. in Pharmaceutics / Pharmaceutical Sciences / Chemistry / Chemical Engineering

Ph.D. (preferred)

Tools

Franz diffusion cells

Viscometers

Rheometers

Penetrometers

Homogenizers

Job description

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.

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.

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.