Next Phase Recruitment
Head of Development
Job Location
Newry & Mourne, United Kingdom
Job Description
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.
Location: Newry & Mourne, GB
Posted Date: 10/27/2024
Contact Information
Contact | Human Resources Next Phase Recruitment |
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