Head of Process Development and Late Stage Formulation Development

Head of Process Development and Late Stage Formulation Development

Catalent

Nottingham, United Kingdom

Position Overview

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Catalent Pharma Solutions are looking to recruit an experienced Head of Process Development and Late Stage Development to join our team in Nottingham.

Your role will see you working with the manufacturing operations and formulation development teams to establish robust transfer and scale up processes which are phase appropriate. Leadership of the process development and late stage formulation group.

The Role

  • Management of the late process development group to realise the ongoing company growth strategy;
  • Provides guidance, mentoring, and development of staff; ensures the team has appropriate skills, capabilities, and resources to meet current and future business needs;
  • Develop and deploy a QBD approach to late stage formulation, scale up and process development;
  • Provides scientific guidance internally and externally to clients on process development and late stage formulation activities;
  • intellectual property considerations with a risk-based assessment approach in line with current regulatory standards;
  • Ensures all development, GMP manufacturing, and process validation activities relating to drug product are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions, meet client timelines and protect the business;
  • Sets the standards and participates in client’s regulatory CMC strategy development, providing pharmaceutical sciences input to Catalent’s reports that will appropriately support our client’s compilation of regulatory submissions for clinical trial and marketing applications;
  • Presents CMC information and manufacturing plans/updates to the Executive Leadership Team and clients, as required.

The Candidate

  • BSc in chemistry, pharmaceutical sciences, chemical engineering, or related scientific discipline;
  • Minimum of 15 years of product/process development and/or commercial manufacturing experience in the pharmaceutical industry;
  • Leadership and managerial experience with a team of CMC development scientists and/or Engineers;
  • You will have in‐depth drug development experience, CMO and management skills;
  • Be able to demonstrate the ability to be part of a cross‐functional team that is responsible for all stages of development, implementation and oversight of effective strategies supply drug product for our clients’ clinical and commercial needs;
  • Has led quality by design or design for manufacture programs;
  • Demonstrated definition of CQAs and CPPs, cycle management;
  • Understands and has a history of the deployment of six sigma tools in pharmaceutical manufacturing;
  • Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization.

Our 7 standard leadership competencies

  • Leads with Integrity and Respect;
  • Delivers Results;
  • Demonstrates Business Acumen;
  • Fosters Collaboration and Teamwork;
  • Champions Change;
  • Engages and Inspires;
  • Coaches and Develops.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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