16 September 2021

Senior QC Materials Analyst

Touchlight are seeking to hire a Senior QC Materials Analyst
Job description:

Role Description

Due to current and expected future growth, Touchlight DNA Services is recruiting for a newly created role with a broad remit to support the business in maximising the potential of recent significant investment, sales growth and a burgeoning DNA industry. You will be a critical member of the team driving Touchlight’s quality and operational success, focussing on all the relevant markets. You will work with some of the biggest healthcare companies in the world to help support the production of dbDNA as a critical starting material for ATMP production and as an Active Pharmaceutical Ingredient.

Touchlight is currently seeking an experienced Senior QC Materials Analyst to join its Quality Control department.  This is a key role, based in the Hampton site (UK), with internal and external facing responsibilities. The role would be suitable for someone with extensive Raw Materials experience in a biologics GMP-regulated CDMO environment, ideally  in the nucleic acids field (DNA and RNA). The role requires an extremely high level of communication, planning and organisation, very dynamic, and ability to thrive in a fast-paced environment, dealing with multiple stakeholders, and managing evolving priorities.

 

The Senior QC Materials Analyst is primarily responsible for establishing the raw materials policy, flow strategy and processes that are required in our regulated environment, as well as leading the sampling and testing of those materials.

 

There will be a close interaction with the other operational departments to support on-going project and product needs.

 

The successful candidate will report directly to the Quality Control Manager.

 

While not exhaustive, the following is a sample of the responsibilities for the role:

  • Provide strategic leadership and oversight of the Raw Materials activities for both internal and external programmes, in line with regulatory expectations.
  • Work collaboratively with Programme Management, Quality, Supply Chain, Development, Manufacturing, and other departments, to meet deliverables and timelines
  • Ensure the organisation can deliver on a highly complex raw material portfolio whilst maintaining a high throughput of customer projects
  • Author documentation such as material policies, specifications, support material inspection and release, as well as QC material ordering and storage area management.
  • Manage appropriate warehouse activities including inspecting incoming materials, receipt & sampling in line with company policies, ensuring compliance and safety before releasing them for use in product manufacture.
  • Define the management and flow strategy of product intermediates, critical raw materials, standards, and consumables.
  • Assist in the performance of health and safety risk assessments, COSHH etc.
  • Support stakeholders with supplier selection as well as assist supplier/vendor qualification.
  • Participate and support investigations for OOS/Deviations /Change controls relating to materials coordinating with production
  • Maintain the calibration, qualification and validation of material testing equipment
  • Work effectively with and have a positive impact on client relationships

 

Skills and Experience

  • Extensive Experience in a GMP Regulated CDMO across the Biopharma and Pharmaceutical industries
  • Bachelor’s Degree in one of the following fields of study: Biology, Biotechnology, Biochemistry, Chemistry
  • 7 years + experience working within QC and Extensive experience in Raw materials management (Chemicals and Biological materials)
  • Experience of reagent preparations and material handling
  • Extensive knowledge of equipment and instrument calibration, qualification, and validation
  • Extensive experience working in a GCLP/GMP laboratory
  • Ability and track record of successfully working in cross‐functional teams to progress projects

 

Applicants MUST be eligible to work in the UK.

Apply for this role by emailing a CV and cover letter to QCjobs@touchlight.com clearly stating the reference “Senior QC Materials Analyst”.