Development Scientist

3 weeks ago

St Asaph, Denbighshire, United Kingdom CONTRACT PHARMA Full time
Job Title: Formulation Development Scientist II

Job Summary:

We are seeking a highly skilled Formulation Development Scientist II to join our team. As a key member of our product development group, you will be responsible for leading development activities for client-based projects, from preclinical studies to NDA submission.

Key Responsibilities:
  • Lead development activities for client-based projects with supervision, including preclinical studies, prototype development, scale-up, and process transfer.
  • Execute prototype, scale-up, and process transfer activities, including manufacture, data evaluation, troubleshooting product/process issues, and risk assessments.
  • Write, review, and approve cGMP documentation, including batch records, protocols, SOPs, pharmaceutical development reports, investigation plans, and outcomes for development problems.
  • Maintain knowledge of equipment, instrumentation, and procedures related to product development.
  • Maintain and expand knowledge of current and new formulation development technologies and manufacturing processes.
  • Perform literature and patent searches to provide a background basis for development plans.
  • Attend cGMP training sessions and comply with site-wide and departmental procedures, including change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
  • Work closely with Analytical Development, Quality Assurance, and Validation groups.
  • May serve as lead for product development activities within cross-departmental project teams.
Requirements:
  • Bachelor's degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, or similar with 5 years of relevant work experience, or Master's degree in one of the areas above with 3 years of relevant work experience.
  • In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry.
  • Familiarity with common pharmaceutical raw materials, their applications, and the principles of formulation development.
  • Working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP, or equivalent.

Benefits:

We offer a competitive total rewards package, including health benefits, annual performance bonuses, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions, and much more.

About Us:

Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. We provide industry-leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging, and logistics services to the global pharmaceutical market.

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