Specialist - Tech Transfer, Formulation (Creams & Semi-Solids) - #1126850

Overview

We are seeking a motivated Formulation Development Specialist/Senior Specialist with expertise in topical cream and semi-solid dosage forms to join our CDMO pharmaceutical development team. In this client-facing role, you will lead and support multiple development projects, from pre-formulation through scale-up and technology transfer to GMP manufacturing. The ideal candidate will thrive in a fast-paced environment working with diverse molecules, formulations, and client requirements.

Key Responsibilities

Formulation & Process Development

• Develop and optimize cream, ointment, and gel formulations for client projects across early-stage, late-stage, and lifecycle programs.

• Conduct pre-formulation studies including API–excipient compatibility, solubility profiling, rheology evaluation, and prototype screening.

• Use QbD and DoE methodologies to identify critical material attributes (CMAs) and critical process parameters (CPPs).

• Assess API impact on emulsion stability, viscosity, microstructure, and overall product performance.

Analytical & Stability Evaluation

• Define product CQAs (viscosity/rheology profile, pH, globule size, release rate, etc.) for semi-solid dosage forms.

• Partner with Analytical Development to establish or refine analytical methods (e.g., HPLC assays, IVRT/IVPT).

• Interpret physical and chemical stability data to guide formulation optimization and risk mitigation strategies.

Scale-Up, Tech Transfer & GMP Support

• Develop robust, scalable manufacturing processes (emulsification, homogenization, heating/cooling cycles, mixing strategies).

• Support pilot-scale batches, engineering runs, and GMP clinical/commercial batch execution.

• Lead or support technical transfer activities to internal or client manufacturing sites.

• Troubleshoot formulation or process deviations in collaboration with Manufacturing and Quality.

Client Collaboration & Project Management

• Serve as a scientific point-of-contact for clients, providing technical updates, data interpretation, and strategic recommendations.

• Prepare and present development plans, timelines, and deliverables in client meetings.

• Ensure project execution aligns with client expectations, regulatory requirements, and CDMO quality standards.

Documentation & Regulatory Support

• Prepare formulation development reports (FDR), technical protocols, batch records, and process descriptions.

• Contribute to CMC documentation for client regulatory filings (IND, NDA, ANDA, IMPD).

• Maintain clear, audit-ready documentation in compliance with GMP and CDMO quality systems.

Qualifications

Education

• Master’s or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline.

• Bachelor’s degree with strong relevant experience may also be considered.

Experience

• 3–8 years’ experience in semisolid formulation development, preferably within a CDMO or fast-paced development environment.

• Demonstrated expertise in emulsions (O/W, W/O), surfactants, rheology modifiers, preservatives, and skin delivery technologies.

• Hands-on experience with pilot-scale equipment, process scale-up, and technology transfer.

• Knowledge of IVRT/IVPT methods and topical regulatory expectations (USP, ICH, FDA, EMA) is an advantage.

Technical & Soft Skills

• Proficiency with rheology tools, viscometers, globule size analyzers, homogenizers, and other semi-solid processing equipment.

• Strong analytical and problem-solving skills; ability to interpret complex formulation and process data.

• Excellent communication and client-facing skills.

• Able to manage multiple concurrent projects and deliver results on accelerated CDMO timelines.

• Strong technical writing and documentation abilities.