HRS Hyper Recruitment Solutions: Analytical Product Manager - CMC

We are currently looking for an Analytical Product Manager to join a leading Life Sciences company based in the Berkshire Area. This is a permanent position where you will pro-actively coordinate internal and external client project activities (analytical CMC development of recombinant proteins) and provide scientific oversight of data generated for the projects.

KEY DUTIES AND RESPONSIBILITIES:

As the Analytical Product Manager you will be responsible for a range of activities including:

1. Primary point of contact for all analytical activities relating to product development and management of analytical development programmes from early phase development through to license application. You will be the primary interface to the Program Management Team, study directors and internal and external customers.

2. Definition, presentation and representation of analytical CMC programmes to customers, potential new customers & external meetings, including oversight of large analytical portfolio projects. Coach and mentor scientists to develop wider CMC knowledge to develop the appropriate expertise and know how to represent Analytical Services.

3. Design and integration of analytical work packages into CMC strategy for product development and alignment to customer requirements for successful product development. In doing so you will have take the final review of study protocols and reports ensuring that studies are delivered to the appropriate and consistent scientific, technical, regulatory and quality standards.

ROLE REQUIREMENTS:

To be successful as the Analytical Product Manager we are looking to identify the following on application:

1. Degree in a relevant life sciences discipline (i.e biotechnology, biological sciences) with proven experience working in contract research or biologics environment and broad project management skills, supporting 360 project cycles.

2. Demonstrated experience in developing a flexible range of high quality analytical services for recombinant protein and IgG molecules with proven experience to support products through all phases of regulatory filings to reduce time to clinic/market.

3. Demonstrated experience in mentoring and leading scientific and technical teams to leverage scientific experience and wisdom in order to deliver a successful analytical CMC package for early phase and late phase products. You will have experience in troubleshooting analytical CMC problems and presenting clear solutions to internal and external project teams.

Key Words: Analytical CMC / Project Management / CMC Product Manager / Biological Project Management / CMC Strategy / Biological CMC / Project lifecycle / GMP Project Management

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.

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