Create a Job Alert.

Enter your email below to save this search and receive job recommendations for similar positions.
Thank you. We'll send jobs matching these to
You already suscribed to this job alert.
No Thanks
UK
What job do you want?

Associate Director Analytical Development - Gene Therapy job in Liverpool at Hyper Recruitment Solutions LTD

Create Job Alert.

Get similar jobs sent to your email

Apply to this job.
Think you're the perfect candidate?
Apply on company site

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Associate Director Analytical Development - Gene Therapy at Hyper Recruitment Solutions LTD

Associate Director Analytical Development - Gene Therapy

Hyper Recruitment Solutions LTD North West England, Merseyside Full Time
Apply on company site

Create Job Alert.

Get similar jobs sent to your email

We are currently looking for a Associate Director Analytical Development - Gene Therapy to join a leading Biologics company based in the North West of the UK. As the Associate Director Analytical Development - Gene Therapy you will the internal Technical Expert for Cellular and Molecular Analytical methods for the assessment of Biological products, specifically Gene Therapy and Vaccine therapeutics.

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
 

Recommended Skills

Enzyme Linked Immunosorbent Assay (Elisa)
Gene Therapy
Polymerase Chain Reaction
Retrovirus
Dna Sequencing
Viral Vector
Apply to this job.
Think you're the perfect candidate?
Apply on company site

Job ID: 213574312

JOBMEDIC.CO.UK TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using Jobmedic.co.uk you are agreeing to comply with and be subject to the Jobmedic.co.uk Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.