An excellent opportunity for an experienced CMC co-ordinator has become available to join a leading Biopharmacuetical company in the Oxfordshire area. As the CMC Technical Specialist you will be responsible for ensuring the on-time delivery of CMC studies through the coordination of Regulatory Activities and Documentation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CMC Technical Specialist will be varied however the key duties and responsibilities are as follows:
1. You will work closely with internal and external clients to ensure delivery of CMC source documentation in support of regulatory submissions. These include high-quality documentation (e.g. technical protocols and reports) related to CMC sections of clinical trial applications and INDs, Marketing Authorisation Applications (MAAs) and Biological Licence Applications (BLAs).
2. You will author plans, protocols and reports to coordinate CMC-related studies and review drafted regulatory documentation to ensure successful submission.
3. Advise on the scope and impact of manufacturing and analytics planned changes and quality incidents.
4. To advise on analytical specifications to meet regulatory and client requirements, and to advise on corresponding acceptance limits
To be successful in your application to this exciting opportunity as the CMC Technical Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Science discipline in addition to extensive experience within a GMP Biologics / Biopharmaceutical environment. An understanding of gene therapy vectors would be beneficial.
2. Proven industry experience in GMP-compliant manufacturing and / or analytics for biological medicinal product to support clinical development and commercial scale-up.
3. A working knowledge and practical experience with of drafting high quality documentation such as technical reports.
Key Words: CMC | Manufacturing | GMP | Technical Documentation | Regulatory Affairs | IND | MAA | CTA | BLA | Strategy Development | Gene Therapy | Viral Vector
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We 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 recruitment processionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Posted: 26th April 2018
- Expires: 24th May 2018
- Reference: J5534