M.S. in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field required; Ph.D. preferred.
Minimum 5 years of experience in formulation development and manufacturing within the pharmaceutical industry.
Hands-on experience with semi-solid and liquid dosage forms, especially suppositories and topical formulations.
Experience in process scale-up and supporting GMP manufacturing activities required.
Strong understanding of pharmaceutical formulation principles and excipient functionality.
Responsibilities
Lead formulation development and optimization for semi-solid and liquid pharmaceutical dosage forms.
Evaluate critical process parameters and material attributes for product performance and stability.
Design and analyze formulation and process development studies using scientific methods.
Apply Quality by Design and Design of Experiments principles in product development.
Support technology transfer and pilot-scale activities for GMP manufacturing operations.
Generate and review comprehensive technical documentation for development processes.
Conduct hands-on formulation activities and physical characterization tests.
Collaborate cross-functionally with various teams to ensure project success.
Benefits
Opportunity for hands-on experience in both laboratory and pilot-scale formulation activities.
Collaboration with cross-functional teams, enhancing professional networking.
Engagement in cutting-edge pharmaceutical development practices.
Contribution to manufacturing investigations and process improvement initiatives.
Full 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.
