Biopharmaceutical Development Manager / Director

Recruiter
Hyper Recruitment Solutions Ltd
Location
Wrexham (Wrecsam)
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
We are currently looking for a Biopharmaceutical Development Manager / Director to join a leading company based in the Wrexham area. The Biopharmaceutical Development Manager / Director position is permanent and based at client's site in North Wales and reports directly to the VP Biologics Development.

This new role will support an existing team and provides an excellent opportunity for an individual with strong biologics development experience and team management skills to shape formulation strategy and team structure. Depending on experience, there is the possibility for this to be a manager or director level role.

The successful applicant will have proven knowledge and technical capabilities across core areas of Formulation Development for novel Biologics. They will possess Biopharmaceutical R&D industry experience managing technical teams with examples of leading organisational and cultural change. In addition, they will have previous involvement with supporting CMC mod 3 regulatory submissions for FDA, EMA etc (e.g. IND/IMPD/CTA's).

KEY DUTIES AND RESPONSIBILITIES:

As the Biopharmaceutical Development Manager / Director you will lead the Formulation Development group as part of Biologics Development (CMC), to deliver a coordinated and detailed Formulation strategy and development program to support toxins and other novel biological products developed and in-licensed by the company. Detailed Responsibilities Include:

1. Lead the Formulation development group & strategy; including design, optimisation and utilisation of fit-for-purpose robust technologies for effective development for novel stable formulations (for bulk drug substance & final-formulated drug products for dosing).

2. Ensure appropriate product understanding & stability, through detailed excipient, pH, temperature (and other factor) screening studies, degradation mechanisms, compatibility with dosing requirements and long-term evaluation to support Tox- Clinical studies, to commercial indications.

3. Leading drug product formulation fill-finish and validation processes to maintain product integrity and development (internally & externally) in line with clinical to commercial processes.

4. Management of the Formulation facilities, staff, recruitment and budgeting to ensure effective performance in line with product development requirements.

5. Providing effective DOE and control strategy implementation (QbD) in co-ordination with analytical and process support, implementation of appropriate technologies and lifecycle strategies, validations in accordance with ICH guidelines (to support cGMP production), and regulatory documentation to support product development plans to first time regulatory approvals.

6. Development & validation of processes to regulatory requirements to support cGMP testing, in coordination with BD/CMC, Quality, Clinical, Operations and Commercial.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Biopharmaceutical Development Manager / Director we are looking to identify the following on your profile and past history:

1. Relevant degree (ideally a PhD) in a life sciences or chemistry based discipline, plus examples of independent research and Formulation development expertise within a Pharmaceutical / Biopharmaceutical Development company, leading teams and product development (CMC) strategies.

2. Proven industry experience working within the field of biologics.

3. A working knowledge and practical experience with leading a team of experienced scientists.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.