Project Manager - CMC

Location
Cambridgeshire
Salary
Dependent on experience
Posted
23 Jun 2017
Closes
21 Jul 2017
Ref
J4084
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
We currently have an exciting opportunity available for a Project Manager - CMC to join a global life sciences company based in the Cambridgeshire area. As the Project Manager - CMC you will be responsible for the establishment and management of in-house and sub-contracted CMC programmes/projects for the CMC development of drug and biologics products for the pharmaceutical and biopharmaceutical industries.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Project Manager - CMC will be varied however the key duties and responsibilities are as follows:

1. Ensuring that all CMC programmes/projects under his/her management meet current and prospective world-wide regulatory compliance, industry guidelines and internationally recognised quality standards. You will maintain an awareness of the competitive marketplace for CMC services in general and CMC programme management and consultancy in particular, to include service expectations.

2. Keeping abreast of regulatory guidelines and industry expectations and contribute to the establishment and delivery of appropriate services.

3. Acting as Programme/Project Manager, liaising with internal and external groups to ensure that the conduct and reporting of the programme/project complies with the requirements of GMP, the Project Plan and relevant SOPs and is delivered on time. Ensuring an appropriate level of communication, at all levels, is maintained with clients and that status and progress reporting meet client requirements.

4. Leading and contributing to meetings with client companies when they visit the department. Working with collaborating departments and groups to improve interdepartmental communication. Ensuring that a quality service is provided by the department, by regular discussions with internal and external customers.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Project Manager - CMC we are looking to identify the following on your profile and past history:

1. Relevant degree in a scientific discipline. You will also be expected to have significant experience working in a CRO or other service oriented environment in a customer facing role. You will also have spent time working in a biopharmaceutical / pharmaceutical analytical environment.

2. An excellent understanding of the CMC development and commercial life cycle for biologics. A broad knowledge of analytical strategies and technologies for biologics.

3. A thorough understanding of GMP regulations and other applicable guidelines.

4. You will be confident with project management tools and software.

Key Words: Project Manager | Project Management | CMC | Biologics | biopharmaceutical | pharmaceutical | biopharmaceutical development | GMP

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.