Drug Product Development Team Leader

We are currently looking for a Drug Product Development Team Leader to join a leading Bio-Pharmaceutical company based in the North West.

As the Drug Product Development Team Leader you will be responsible for delivering a coordinated and detailed phase dependent drug product development strategy to facilitate effective GMP Manufacture of Drug Products.



KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Drug Product Development Team Leader will be varied however the key duties and responsibilities are as follows:

1.

You will effectively lead Drug Product Development projects using a Design of Experiments (DoE) approach to ensure timely and effective delivery of Drug Product Manufacturing initiatives including phase dependent process development, scale-up, tech transfer, GMP manufacture for pipeline projects, using effective collaboration with internal and external stakeholders.



2.

The Drug Product Development Team Leader will interface with the wider Formulation and Biologics Development CMC groups (incl Analytical & Bioprocess development) to support development of novel biologics and provide technical input for Biologics Development CMC projects.

Identify, liaise and work with third parties (such as CROs/external Fill-Finish facilities) in order to progress CMC activities, including review of proposals, protocols and reports.

3.

Maintain up-to-date knowledge on drug product process techniques, issues and development strategies, along with identifying & implementing state of the art technologies to allow for on/at-line measurements of process parameters to accelerate development of suitable DP processes.

You will also drive CAPEX projects associated with improvement or introduction of new facilities and equipment to support drug product development strategy.

4.

Drive and monitor compliance with relevant regulations (e.g.EHS/GxP/Quality) and ensure the team are working in a safe manner at all times, promote proactive safety and compliance culture working closely with quality and safety teams.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Drug Product Development Team Leader we are looking to identify the following on your profile and past history:

1.

Relevant degree in a life science or related discipline.



2.

Proven industry experience in pharmaceutical Research & Development, with experience in drug product process development, scale up/tech transfer, Drug Product QC Release and/or Formulation.

3.

A working knowledge and practical experience with the CMC Development of Biologics.

Key Words: Formulation | Development | Process Development | Lyophilisation | Biopharmaceutical | Pharmaceutical | Biotechnology | Biotech | Biochemistry | CMC | GMP | Biologics | Fill Finish | Sterile | Manufacturing | Drug Product | DP | Team Lead | Management | DoE | QbD

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development.

We therefore welcome applications for any interested parties who fulfil the role requirements for this position.

HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists.

We look forward to helping you with your next career moves.