Associate Director Analytical Development - Gene Therapy
- Employer
- Hyper Recruitment Solutions
- Location
- North West England
- Salary
- Competitive
- Closing date
- 2 Jul 2021
View more
- Sector
- Biology, Molecular Biology
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
You will work cross functional with Analytical Development, Process Development and CMC teams as well as with external collaborators and clients to ensure the successful development of novel Therapeutics.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Associate Director Analytical Development - Gene Therapy will be varied however the key duties and responsibilities are as follows:
1. Responsible for defining strategy for CMC analytics to support product and process development with a focus on designing Biological Characterisation plans to ensure processes meet internal and external guidelines including ICH regulatory guidelines,
2. Act as Technical lead and Subject Matter Expert for the development, optimisation and transfer of routine and non-routine methods including but not limited to PCR, ddPCR, ELISA, Cell-based Assays (for viral analysis) and sequencing methods including Sanger and NGS.
3. Review technical data and troubleshoot accordingly to support Method Development and Validation activities.
4. Prepare, review and approve analytical biological characterisation data to support regulatory filings and address subsequent regulatory questions.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Associate Director Analytical Development - Gene Therapy we are looking to identify the following on your profile and past history:
1. Relevant degree in a Biologics Life Sciences discipline. PhD is preferred but not required as well as relevant industry experience in a Biologics industry, ideally with a focus on Viral and Gene Therapies.
2. Proven industry experience in the Characterisation of Biological products where you are a technical expert in one of more of the following techniques: PCR, ddPCR, ELISA, Sanger Sequencing, Next Generation Sequencing (NGS), Cell based and Bioassys for viral protein analysis.
3. A working knowledge and practical experience with technical and regulatory strategy for CMC and Characterisation. Experience of ATMPs and Regulatory Agency interactions would be beneficial.
Key Words: Associate Director | Analytical Development | Method Development and Validation | Characterisation | Process Development | CMC | Biopharmaceutical | Biologics | Viral Vectors | Gene Therapy | Vaccines | Viruses | AAV | Retrovirus |
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.
Company
Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.
Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.
Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.
We provide services across a broad range of industries including the following specialist sectors:
• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science
With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:
• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments
HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.
Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com
Or any of the social media routes below:
Twitter
Facebook
Linked in
Google +
- Website
- http://www.hyperec.com/
- Telephone
- 0203 910 2980
- Location
-
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
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