|Job Ref:||EMP371772||Employer:||Matchtech Group plc.||Country:||United Kingdom||County/State:||Yorkshire||Address:||Salary:||£40,000 - £50,000/year||Post Date:||14/10/2016 21:33|
Due to some exciting plans for expansion we are looking for an exceptional scientist to join our client's CMC Division. This is the perfect opportunity for someone with strong CMC analytics experience looking to progress into a Lead-level position.|
Proven relevant experience within a GMP environment.
As part of the Molecular Management Group, the Lead Scientist will manage a broad range of multi-technique projects to both internal and external clients and will act as a key point of contact for these projects within biopharma CMC (large molecules).
- Lead scientific teams to ensure that client requirements are met.
- Provide oversight of scientific progress of projects to ensure the successful, initiation, planning, execution, monitoring and completion of projects.
- Communicate with internal and external project teams, departmental management and the Client to ensure effective scientific progress throughout the project life cycle.
- Navigate the regulatory framework to ensure that the client programs are conducted to meet the defined milestones along the drug development pathway with scientific integrity.
- Write protocols and reports using the QC scientist approved data that fulfils the protocol design and all regulatory expectations.
- Identify and communicate scientific and regulatory developments to the molecule management team and the wider senior scientific group (Method Development and QC Scientists).
Candidate Skills & Responsibilities:
- Proven experience within CMC Analytics - gained within a biopharma/pharma company or CRO.
- A working knowledge of a wide range of CMC analytical techniques - to include some of the following: HPLC techniques, MS, ELISA, PCR, cell culture.
- Working knowledge of statistics and it’s application to techniques and regulatory applications (validation, equivalence).
- An up to date knowledge of regulatory guidelines and their application.
- Commercial awareness, interpersonal and negotiating skills.
- The ability to get things done by influencing others (both internal and external).
- Learn and maintain knowledge of process excellence processes, tools and activities.
For this position we can offer a highly competitive salary and benefits package which will reflect the importance of the role.
For more information please feel free to call NA.