Lead Process Scientist

ZipRecruiter; Wrexham; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Lead Process Scientist for a 6-month contract in Wrexham. The role involves leading the process transfer for new Drug Substance manufacturing processes, ensuring compliance and optimizing production strategies. Applicants must have a relevant scientific degree and a solid understanding of CMC activities. Competitive salary offered with flexible contracting options.

Qualifications

• Hold a relevant scientific degree or have equivalent working knowledge.
• Have a broad understanding of CMC activities and regulatory strategy.
• Able to perform technical/critical review of data from Drug substance process.

Responsibilities

• Lead the process transfer of Drug Substance manufacturing process.
• Ensure documentation supports process design for Regulatory examination.
• Identify gaps in process design and provide remediation guidance.

Skills

Stakeholder management

Technical review

Knowledge of Drug Substance operations

Education

Relevant scientific degree or equivalent experience

Job description

Job Description

CK Group are recruiting for a Lead Process Scientist to join a leading biopharmaceutical company on a contract basis for 6 months.

Salary:
£193.56 per day PAYE or £250 per day via umbrella or Ltd company. This role has been assessed as outside IR35.

Lead Process Scientist Role:

• Lead the process transfer of Drug Substance (DS) manufacturing process for new products from development to manufacturing.
• Ensure process knowledge and control strategies are appropriate to ensure Drug Substance processes operate in a reliable, cost effective, safe, and compliant manner.
• Ensure documentation is ready and available to support the process design Drug Substances ahead of Regulatory examination.
• Ensure any gaps in the process design and/or control strategy are identified.
• Provide guidance for the remediation of any gaps in design, optimisation and implementation of DS manufacturing processes utilising scientific principles, process, and product knowledge.

Your Background:

• Hold a relevant scientific degree or have equivalent working knowledge.
• Have a broad understanding of CMC activities, regulatory strategy, understand risks and be able to link actions to Manufacturing Science and Technology.
• Able to perform technical/critical review of data from Drug substance process, including Upstream and Downstream steps.
• Excellent stakeholder management and the ability to influence and challenge.
• Knowledge of Drug Substance unit operations.
• Ability to define work plans, execute and provide technical updates to project teams.

Company:
Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical need.

Location:
This role is based at our clients site in Wrexham.

Apply:
For more information, or to apply for this a Lead Process Scientistrole please contact the Key Accounts Team on 01438 870011 or email [e-mail]. Please quote job reference 148 356.
It is essential that applicants hold entitlement to work in the UK.

Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

INDKA