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CMC Project Manager

Employer
Hyper Recruitment Solutions
Location
Hertfordshire
Salary
Competitve
Closing date
22 Jul 2021

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Job Details


We have an exciting opportunity available for a CMC Project Manager to join a growing life sciences company based in the Hertfordshire area.

As the CMC Project Manager, you will be accountable for developing and enhancing the company's capabilities in the areas of drug development, regulatory compliance and leadership.

Based on understanding regulatory requirements, the incumbent will be accountable for driving the generation of appropriate and well controlled technical documents maximizing the chances of first time approval and minimizing the need for change applications.
In the leadership part of the role, the incumbent will influence all departments to develop robust development plans for pipe line projects as well as existing products ensuring regulatory compliance is maintained at all times and across functions.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Establish boiler plate templates for CTD sections to ensure standardisation with regards to content and level of detail based on continuous agency feedback.

2. Acts as a technical expert in: Assessing the manufacturing change controls for all products and intermediates across products and countries, establish in collaboration with the product owners the supportive documentation required to support the filing of the manufacturing changes, negotiate and agree with Validation, R&D, Production, Supply Chain, Quality and Engineering the level of data required for submission, and what would rather be nice to have (risk assessment), writing of the dossier sections as per ICH standards and in line with the templates developed.

3. Follow current and emerging regulatory requirements and guidelines in the CMC field in order to advise other functions on possible implications. Assist in establishing a robust process for the management of CMC regulatory commitments.

4. Help foster continuous improvement mind-set across functions that all regulatory submissions are of highest regulatory standards (reader friendly, accurate, complete, lessons learned from agency feedback are continuously implemented).

5. Work in a Hands-on manner with submission content to develop standards to ensure good technical documents and speedy approvals due to reduction in requests for clarification and repeat questions while building knowledge of regulatory requirements and regulatory procedures to obtain new licenses and maintain existing licenses.

6. Assist with the scientific writing where needed and perform critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, complex amendments and supplements to ensure a high-quality regulatory submission and smooth approval. Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs for specific, or complex changes.

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 related science or technical field. In addition, you will need significant experience working in the pharmaceutical, biopharmaceutical or similar field.

2. Proven industry experience of cGMPs (MHRA, US, EU,) for biologics or pharmaceuticals, and knowledge of biologics / pharmaceuticals manufacturing compliance.

3. Strong leadership, management experience, and technical skills required, and you will have demonstrated success and leadership of multifunctional and multi-site teams.

4. Proven ability to manage complex projects through successful implementation.


Key Words: CMC | Biopharmaceuticals | Pharmaceuticals | Project Manager | GMP

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. 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: 
Twitter
Facebook
Linked in
Google +

Find Us
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
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