Downstream Processing Team Leader

Location
Iceland
Salary
Dependent on experience
Posted
19 Oct 2018
Closes
16 Nov 2018
Ref
J563022
Contact
Gregory Hammond
Contract Type
Permanent
Hours
Full Time
We are currently looking for a Downstream Processing Team Leader with a focus on Process Characterisation to join an exciting Biotechnology company based in Reykjavik, Iceland. As the Downstream Process Characterisation Team Leader you will be responsible for Leading the DSP Characterisation team to optimise and characterise the downstream process, with the aim to transfer for clinical and/or commercial manufacture.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Downstream Process Characterisation Team Leader will be varied however the key duties and responsibilities are as follows:

1. You will design and execute process characterisation and process validation activities associated with the manufacturing process for late stage projects and in support of the regulatory submissions.

2. Provide technical, scientific leadership and guidance to team members to ensure the efficient development and characterization of an optimized downstream process for the product pipeline.

3. Support tech transfer with manufacturing organizations (internal and external), scale up, troubleshooting, process changes and regulatory submissions.

4. SME author/reviewer and/or approver for written procedures, technical documents, reports and other cGMP documentations in span of expertise.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Downstream Process Characterisation Team Leader we are looking to identify the following on your profile and past history:

1. Relevant degree in a Biotechnology / Biochemical Engineering discipline or similar along with significant industry experience.

2. Proven industry experience in downstream purification activities to aseptically purify protein antibodies (in both production and lab scale) including hands-on expertise operating downstream equipment.

3. A working knowledge and practical experience with supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.

Key Words: Downstream | Process | Process Characterisation | GMP | DSP | MAbs | Tech Transfer | Development | Biopharmaceutical | Biotechnology | Pharmaceutical | Manager | Team Leader | Purification | AKTA | TFF |

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.

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