Job Details

The Pharmaceutical Development Scientist is a hands-on technical role responsible for the formulation, development, optimization, and technology transfer of sterile and non-sterile drug products across STAQ Pharma's 503B Outsourcing Facilities. Reporting directly to the Chief Pharmaceutical Officer, this position supports product development initiatives from concept through scale-up and commercialization, driving innovation, process improvement, and lifecycle management of compounded drug products.

The scientist collaborates closely with Manufacturing Sciences & Technology (MS&T), Quality, and Production teams to translate laboratory-scale formulations into scalable, validated CGMP manufacturing processes. Responsibilities include conducting pre-formulation and compatibility studies, preparing R&D and pilot-scale batches, and analyzing analytical and stability data to identify optimal formulations that maximize quality, performance, and product expiration dating.

This role requires strong analytical chemistry expertise—including the ability to interpret UPLC chromatograms, assess impurity profiles, and apply ICH and FDA 503B guidance—to guide formulation strategy, product development, and technology transfer activities.

Key Responsibilities:

• Develop, optimize, and scale formulations for sterile and non-sterile dosage forms in compliance with CGMP, FDA 503B, and ICH guidelines.
• Conduct pre-formulation studies, excipient compatibility testing, and stability evaluations to inform formulation design and shelf-life optimization.
• Design and execute experiments to assess formulation feasibility, process robustness, and long-term product stability.
• Prepare and manufacture laboratory-scale, R&D, and pilot-scale batches for testing and process development.
• Lead and support technology transfer activities for new and existing products, ensuring seamless transition from R&D to manufacturing and between STAQ Pharma sites.
• Conduct literature reviews and data analysis to identify innovative formulation approaches and support development strategy.
• Analyze data from HPLC, GC, dissolution, and stability studies to assess potency, purity, and impurity profiles.
• Collaborate with MS&T, Quality, and Production teams to ensure manufacturing processes are robust, validated, and scalable.
• Develop and execute stability protocols, trend data, and prepare detailed technical summaries and reports.
• Write and maintain technical documentation, including batch records, development protocols, SOPs, and technical reports in accordance with CGMP standards.
• Support investigations of out-of-specification (OOS) or out-of-trend (OOT) results and contribute to CAPA development and implementation.
• Participate in audits, inspections, and internal quality reviews to ensure regulatory and operational compliance.

Qualifications:

• Bachelor's, Master's, or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.
• Minimum of 3–5 years of hands-on experience in CGMP pharmaceutical formulation or product development (503B, CDMO, or sterile pharma manufacturing preferred).
• Demonstrated experience in formulation design, stability testing, and technology transfer.
• Proficiency in analytical chemistry techniques, including UPLC, GC, and dissolution testing; ability to interpret chromatograms and impurity profiles.
• Strong working knowledge of ICH Q8–Q10, FDA 503B guidance, and applicable USP chapters.
• Experience in scale-up and process optimization for aseptic and non-sterile drug products.
• Excellent technical writing, communication, and organizational skills.
• Ability to work independently, prioritize multiple projects, and collaborate effectively across cross-functional teams and sites.