We are currently looking for a CMC Technical Lead - Process Chemistry to join a leading Biotech company based in the London area. As the CMC Technical Lead - Process Chemistry you will be responsible for leading process development and manufacturing projects for toxins.
This is an exciting opportunity for an experienced Process Development Chemist Lead that is keen to be in a highly strategic role.
In this role you will required to be in the office 2 - 3 times a month and you are expected to travel internationally every 2 - 3 months to develop the relationships with CMOs,
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CMC Technical Lead - Process Chemistry will be varied however the key duties and responsibilities are as follows:
1. You will be leading PD and Manufacturing projects that are outsourced to international CDMOs (based in EU & Asia)
2. You will write-up the chemistry CMC sections for regulatory submissions (INDs,MAAs or BLAs)
3. Be responsible for the overall strategy in the CMC team.
4. Work collaboratively with the wider CMC team to drive positive outcomes.
To be successful in your application to this exciting opportunity as the CMC Technical Lead - Process Chemistry we are looking to identify the following on your profile and past history:
1. Relevant degree in Chemistry. A PhD is advantageous.
2. Proven industry experience in a pharmaceutical / CDMO / CMO with a process chemistry expertise.
3. A working experience with leading projects and experience with writing up sections for IND or MAA or BLA submissions.
Key Words: Process Chemistry / Process Validation / CMC / Cytotoxins / Toxins / Process Development / Project Lead / Director / Strategic / IND / BLA / MAA / Regulatory Submissions / Hybrid / WFH / London
You must have the right to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Reference: J5636908
Website: Hyper Recruitment Solutions
- Posted: 7th September 2022
- Expires: 5th October 2022