CMC Project Manager
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.
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.