16 September 2021

Senior QC Analyst

Touchlight are seeking to hire a Senior QC 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 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 QC 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 Analyst is a subject matter expert in the requirements of a Quality Control Laboratory and is primarily responsible for establishing the QC policies and processes that are required in our regulated environment, as well as assisting with the QC analytical activities for our clients and internal pipeline.

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:

  • Analytical method development and validation expertise gained on projects in a GMP setting
  • Proven experience writing method validation protocols and using industry leading analytical equipment
  • Project manage the analytical activities of several products and represent the QC department on Customer Project Teams including method transfers, method qualification & validation, batch release testing and stability.
  • Communicate project requirements to QC stakeholders and provide updates to the Client and Project Team.
  • Effectively manage the Client relationship from an analytical perspective; act as the primary analytical contract drawing on relevant subject matter experts as required.
  • Lead the provision of information to produce sampling plans and support the specification setting activities.
  • Working with key stakeholders in QC create detailed analytical plans including timelines, deliverables, and costings.
  • Responsible for tracking project progress against scope, timelines, and milestones.
  • Identify potential risks to projects and develop and implement risk mitigation strategies.
  • Support both analytical and manufacturing investigations, including participating in RCA, for deviations, OOS associated with the project.
  • Assist with preparing proposals for prospective new clients

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 GMP Laboratory environment
  • Experience of sampling techniques, reagent preparations, Industry standard Analytical methods and material handling
  • Extensive knowledge of equipment and instrument calibration, qualification, and validation
  • 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 Analyst”.