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CMC Project Manager

Employer
Hyper Recruitment Solutions
Location
Reading
Salary
£0 per annum
Closing date
29 Aug 2019

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Sector
Chemistry, Pharmaceutical
Contract Type
Permanent
Hours
Full Time

Job Details

Hyper Recruitment Solutions 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 portfolio from pre-clinical 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, which is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.

Company

Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.

Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.

Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.

We provide services across a broad range of industries including the following specialist sectors:

• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science

With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:


• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability 
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments


HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.

Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com


Or any of the social media routes below: 
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Company info
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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