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.
Read LessThe Senior Microbiologist is responsible for executing complex microbiological assays and limit tests while ensuring strict compliance with cGMP regulations and safety standards. This role provides technical leadership through method validation, laboratory investigations, and the mentorship of junior staff to support the Quality Laboratory’s operational goals. Po
Perform microbiological assay of Cyanocobalamin (B12), Folic Acid, Niacinamide, Biotin and Pantothenic Acid on finished products.Conduct Sterility Testing and Bacterial Endotoxin Testing (BET) to ensure product safety and compliance with pharmacopeial standards.Execute Antimicrobial Effectiveness Testing (AET) to evaluate preservative efficacy in multi-dose formulations.Conduct comprehensive microbiological limit tests per USP <61> and USP <62>.Manage environmental monitoring programs, including the collection and trend analysis of water, swab, and air samples.Oversee the maintenance, culturing, and freezing of live microbiological agents and molds used in suitability studies.Utilize, maintain, and troubleshoot critical instrumentation, including Steritest units, LAL Kinetic readers, microscopes, autoclaves, incubators, and biological safety cabinets (BSC).Author standard operating procedures and microbiological methods.Perform and document thorough laboratory investigations for deviations or out-of-specification (OOS) results.Perform and document work in compliance with standard operating procedures, cGMP regulations, and applicable laboratory safety standards.Review laboratory notebooks for accuracy, completeness, and adherence to cGMP standards. Execute and/or assist with equipment calibrations, qualifications (IQ/OQ/PQ), method validations, and method transfers.Perform method validations, method transfers, and method troubleshooting.Assist laboratory management in preparation for internal, customer and agency audits.Train and guide new colleagues on laboratory protocols and aseptic techniques.May be responsible for specific areas, functions, projects, and/or instrumentation based on experience and expertise.Other related duties as required.
QUALIFICATIONS:
Bachelor’s degree in microbiology or closely related discipline.8+ years' experience in microbiological and/or chemistry laboratory.8+ years' experience with aseptic technique and use of microbiological test methods.Demonstrate a strong commitment to being a team player by actively collaborating with cross-functional colleagues, sharing technical knowledge, and maintaining a positive work environment to achieve collective laboratory goals.Deep understanding of cGMP regulations, laboratory safety standards, and instrumentation troubleshooting.Strong communication skills, both written and verbal.Exceptional attention to detail and ability to follow complex SOPs.Ability to prioritize and manage concurrent tasks with minimal supervision.Desire to work in a positive team 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.
