Head of Building Development

2 weeks ago

Newry Co Down, United Kingdom Next Phase Recruitment Full time

Head of Pharmaceutical Development – Formulations
Job Overview:
We are seeking a 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. You will ensure 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.
Act as the primary contact for assessing new product candidates and providing cost estimates for associated work.
Develop chemical and physical analytical methods for early-stage product development.
Implement the Quality by Design (QbD) approach in Pharmaceutical Development.
Identify and evaluate Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs).
Develop robust, scalable manufacturing processes.
Reverse engineer commercial reference products.
Manage and lead the teams to ensure goals and objectives are met in accordance with quality, regulatory, and contractual standards.
Oversee the manufacture of products for clinical evaluations, ensuring timely delivery.
Lead risk analysis to support the tech transfer process for formulations, manufacturing, and analytical methods.
Establish and maintain key performance indicators for delivering projects on time and within budget.
Drive capacity analysis within the team to optimize the use of resources and equipment.
Work cross-functionally to improve team performance and meet project goals.
Conduct performance reviews to retain and enhance staff skills.
Play a key role in Chemistry, Manufacturing, and Control (CMC) on project teams.
Prepare budgets for the Formulations teams and monitor spending against budgeted costs.
Troubleshoot technical issues using innovative solutions.
Support the preparation and review of technical documents and Standard Operating Procedures.
Contribute to the compilation and review of CMC sections of regulatory dossiers and address regulatory queries as needed.
Ensure a safe working environment in line with Health and Safety requirements.
Manage interfaces with contract facilities and maintain progress on programs, ensuring adherence to quality and contractual standards.
Ensure 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.
Maintain an awareness of trends and emerging technologies in pharmaceutical manufacturing and analytical methods.
Manage timesheet system resources and ensure proper logging of hours.
Conduct 1:1 meetings with direct reports and manage their performance.
Drive a culture of ownership and accountability within the team.

Essential Criteria:
PhD in Pharmacy, Chemistry, or Pharmaceutical Sciences.
Minimum of 10 years of relevant experience in the pharmaceutical industry, particularly in product development or manufacturing environments.
At least 5 years of experience managing large teams with formulation and analytical capabilities.
Strong understanding of formulation and process development technologies across dosage forms.
Competent in chemical and physical analytical methods for formulation development.
Expertise in dosage form development, particularly for orals and injectables.
Proven experience in technical transfers to Manufacturing Operations.
Strong project management and leadership skills.
Excellent written and verbal communication skills.
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.
~15+ years of experience in the pharmaceutical industry.
~ Knowledge of EU and US regulatory environments.


Additional Information:
Full-time, permanent role.
Proof of the right to work in the UK is required.
This role is based at a site that produces penicillin products and may not be suitable for those with a penicillin allergy.
Applications received after the closing date will not be accepted. Visa sponsorship is not available for this role.

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