Formulation Scientist
Oral Solid Dosage

About the Role

As Formulation Scientist – OSD, you will independently design and develop oral solid dosage forms — including immediate-release tablets, hard-shell capsules, film-coated tablets, and modified-release (MR) products — for our MHRA, TGA, and WHO-regulated product portfolio. You will collaborate closely with analytical chemistry, process engineering, and regulatory affairs teams to bring novel and generic formulations from concept through to commercial manufacturing.

This role offers outstanding exposure to complex drug delivery challenges, international regulatory standards, and market-leading pharmaceutical development practices.

Key Responsibilities

• Conduct preformulation studies including solubility screening, API characterisation (particle size, polymorphism), and excipient compatibility testing
• Design and develop IR, MR, and film-coated tablet formulations and hard/soft gelatin capsule formulations using DoE-based optimisation
• Execute laboratory-scale batch manufacturing using compression, coating, and encapsulation equipment; interpret results and iterate formulation
• Lead scale-up activities from lab to pilot scale and support tech transfer to the manufacturing facility, including process parameter setting
• Prepare CTD Module 3 pharmaceutical development sections (P.2) and stability summary reports for regulatory submissions
• Design and oversee ICH stability studies (accelerated, intermediate, long-term) and interpret data against regulatory specifications
• Develop bio-relevant dissolution methods and correlate in vitro dissolution profiles with bioavailability data where applicable
• Collaborate with QC for in-process specification setting and analytical method development/transfer
• Support MHRA, TGA, and internal audit preparation — respond to technical queries on formulation rationale and development history

Qualifications & Experience

• M.Pharm in Pharmaceutics or Industrial Pharmacy; B.Pharm with strong OSD development experience considered
• 3–6 years of hands-on OSD formulation development experience in a pharmaceutical manufacturing or CDMO environment
• Experience with immediate-release and modified-release solid dosage forms; demonstrated MR matrix or coating polymer experience (HPMC, EC, Eudragit) preferred
• Proficiency with OSD equipment: tablet presses (Fette, Manesty, Korsch), coating pans (Glatt, O'Hara), and encapsulators (Bosch, MG2)
• Working knowledge of SUPAC guidelines, ICH Q8/Q9/Q10, and BP/USP/IP pharmacopoeia dissolution testing requirements
• Experience with dissolution testing apparatus (USP II paddle, USP IV flow-through) and bio-relevant media (FaSSIF, FeSSIF)
• Understanding of QbD principles, risk assessment (FMEA), and design space establishment
• Strong technical documentation and scientific writing skills; experience with Pharmaceutical Development Reports