Formulation R&D Scientist

2 weeks ago

Hsinchu City, Taiwan Synmosa Biopharma Corporation Full time $70,000 - $120,000 per year

We are seeking a highly motivated and innovative R&D Scientist to join our pharmaceutical development team. The successful candidate will contribute to the design, formulation, development, and optimization of drug products, with a focus on quality, scalability, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Regulatory, Analytical/QC, Quality, Manufacturing, and Business Development.

  • Key Responsibilities

  • Conduct research and development of new drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.)

  • Follow Quality by Design to plan & execute lab-scale experiments, stability studies, and process development activities including DOE.
  • Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival.
  • Develop & optimize manufacturing processes in compliance with cGMP requirements.
  • Participate in Technology transfer to manufacture pilot, scale up, submission & commercial batches.
  • Prepare technical documents, as per cGMP & ICH for execution and manufacturing including batch records, protocols and reports.
  • Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), product development report, overall quality summary (OQS) etc.
  • Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection.
  • Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers.

  • Collaborate with cross-functional teams on project timelines and deliverables

  • Job Requirements

Master's or Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or related field

  1. 5–10 years of experience in Pharmaceutical R&D for Nasal Product Development.
  2. Strong documentation, development, regulations (USFDA, EMA), analytical, and problem-solving skills

  3. Excellent communication skills in English (written and spoken)

  4. Preferred

  5. Experience in non-infringing formulation design & 505 B2 for USFDA/EMA.

  6. Hands on experience on manufacturing & filling equipment, NGI (DUSA, APSD, Plume geometry, breathing simulators) & HPLC.
  7. Soft skills requirement: Drive for Results, Teamwork, Service Mindset, Embracing Change and Problem-Solving skills.

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