CMC Project Manager - Pharmaceutical

3 days left

Location
Berkshire
Salary
Experience dependent
Posted
02 May 2017
Closes
30 May 2017
Ref
J3833
Contact
Ricky Martin
Contract Type
Permanent
Hours
Full Time
We are currently looking for a CMC Project Manager to join a leading company Pharmaceutical based in the Berkshire area. As the CMC Project Manager you will be responsible for supporting the development and project management of new assets within our client's pharmaceutical product portfolio from preclinical to commercialisation.

KEY DUTIES AND RESPONSIBILITIES:

With a main focus on CMC deliverables, will also be interfacing with product development, regulatory and clinical development to ensure key project milestones are delivered on time and on budget. Your duties as the CMC Project Manager will be varied however the key duties and responsibilities are as follows:

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

1. You will assist global product development programs and lead development and clinical manufacturing of API and drug product for assigned project(s).

2. Work to and maintain a high level of Good Manufacturing Practice (GMP) according to MHRA and FDA and relevant Guidelines. You will also take a lead in the selection and management of suitable CMO/vendors.

3. As the CMC Project Manager you will take oversight of Product Specification File (and input into TMF) and related documentation, you will review/input into appropriate regulatory documentation.

ROLE REQUIREMENTS:

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

1. Relevant degree in a life sciences discipline (i.e. Pharmaceutical Chemistry / Biological Sciences / Chemistry etc) with proven industry experience in API / Drug product development / manufacturer and CMC project management. It is expected this is from a highly compliant Pharmaceutical company with a robust QMS in line with GMP.

2. Proven industry experience with pharmaceutical manufacturing processes (CMC) with a strong knowledge in sterile, solid and / or liquid dosage forms, is expected.

3. A working knowledge and practical experience with regulatory development (including interaction with Competent Authorities at Scientific Advice / pre-submission meetings) as well as clinical supplied managements, will be an advantage, however is not essential.

Key Words: Project Management / PMP / Prince2 / Project Manager / CMC / Chemistry Manufacturer Controls / Pharmaceutical Project Management / Product Development / API Development / CMC

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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