Head of Pharmaceutical Development Formulations Lead

6 days ago

Newry, United Kingdom SLS Services Limited Full time

We are seeking a highly skilled and experienced Head of Pharmaceutical Development Formulations to lead our R&D Pharmaceutical Development team, including Early and Late-Stage Formulations, and the Formulations Analytical Laboratory. In this role, you will oversee the development, scale-up, and characterization of new product formulations, ensuring all activities align with the company's Quality Manual, Standard Operating Procedures, and quality standards.

Key Responsibilities:

  • Provide strategic leadership to the Formulations teams to support new product introductions, ensuring timely delivery and meeting quality, regulatory, and contractual standards.
  • Act as the primary contact for assessing new product candidates and providing cost estimates for associated work, utilizing your expertise in formulation and process development technologies.
  • Develop chemical and physical analytical methods for early-stage product development, leveraging your knowledge of formulation and process development technologies.
  • Implement the Quality by Design (QbD) approach in Pharmaceutical Development, identifying and evaluating Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs).
  • Manage and lead the teams to ensure goals and objectives are met, driving a culture of ownership and accountability within the team.
  • Oversee the manufacture of products for clinical evaluations, ensuring timely delivery and meeting quality, regulatory, and contractual standards.
  • Lead risk analysis to support the tech transfer process for formulations, manufacturing, and analytical methods, ensuring a safe working environment in line with Health and Safety requirements.
  • Establish and maintain key performance indicators for delivering projects on time and within budget, driving capacity analysis within the team to optimize the use of resources and equipment.
  • Work cross-functionally to improve team performance and meet project goals, conducting performance reviews to retain and enhance staff skills.
  • Conduct 1:1 meetings with direct reports and manage their performance, ensuring all work complies with current guidelines (USP, Ph Eur, (V)ICH) and industry best practices.
  • Oversee the audit-readiness of the Formulations and Formulations Analytical Laboratories, maintaining an awareness of trends and emerging technologies in pharmaceutical manufacturing and analytical methods.
  • Manage timesheet system resources and ensure proper logging of hours, driving a culture of ownership and accountability within the team.

Essential Criteria:

  • PhD in Pharmacy, Chemistry, or Pharmaceutical Sciences, with a strong understanding of formulation and process development technologies.
  • Minimum of 10 years of relevant experience in the pharmaceutical industry, particularly in product development or manufacturing environments, with at least 5 years of experience managing large teams with formulation and analytical capabilities.
  • Strong project management and leadership skills, with excellent written and verbal communication skills, and experience with Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) and regulatory compliance.

Desirable Criteria:

  • Experience with AI applications in formulation development, expertise in in-vitro method development to demonstrate in-vitro/in-vivo correlations, and knowledge of EU and US regulatory environments.

Additional Information:

  • This is a full-time, permanent role, requiring proof of the right to work in the UK, and may not be suitable for those with a penicillin allergy.
  • Applications received after the closing date will not be accepted, and visa sponsorship is not available for this role.

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