Analytical Services Manager

Location
Oxfordshire
Salary
Competitive
Posted
24 Apr 2017
Closes
22 May 2017
Ref
J3831
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
We currently have a fantastic opportunity for a Analytical Services Manager to join a innovative biotechnology company based in the Oxfordshire area.

Our client have recently secured significant investment, resulting in unprecedented company growth and individual development opportunities.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Analytical Services Manager will be varied however the key duties and responsibilities are as follows:

1. You will work with the Manufacturing Manager in the provision of drug product in support on our client's projects and programmes, and provide analytical data in support of clinical programmes.

2. Liaison with and oversight of contract quality control testing laboratories to support batch release and ensure the execution of analytical activities to ensure timely batch release.

3. Responsible for joint approval of assay transfer and validation protocols. You will take responsibility for technical review of assay results.

4. Participate in periodic joint steering committee meetings with contract testing laboratories. Contribute to the establishment of contracts with third party analytical laboratories.

5. Internal lead on resolution of deviation events at contract laboratories and OOT/OOS results. Maintenance of a database to enable result/control trending and annual regulatory reports. You will also have responsibility for drafting analytical sections of regulatory submissions including, but not limited to sections 3.2.s.4, 3.2.p.5 section 4 and section 5 of CTD's.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Analytical Services Manager we are looking to identify the following on your profile and past history:

1. Relevant degree (or higher) in a biological or chemistry based discipline. In addition to this, you will require direct experience of a range of analytical techniques used in the release and characterisation of viral therapies and other biological based therapies.

2. Proven experience managing a testing laboratory, including taking responsibility for transfer and validation of analytical methods to third parties.

3. Experience participating in audits by national competent authorities, and contributing to the writing of modules 3, 4 and 5 of the CTD.

4. Experience in the supervision of third party testing laboratories.

Key Words: Analytical Services | Method Transfer | Method Validation | Management | Third Party Testing | Batch Release | Characterisation | Biopharmaceuticals | Biotherapeutics | Biologics | Biological | Viral Therapies

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.