Head of Analytical DevelopmentTouchlight are seeking to hire a Head of Analytical Development
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 operational success globally, 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.
The Head Analytical Development 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 Analytical Development 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 Head of Analytical Development leads the development of methods for the characterisation and analysis of nucleic acids (dbDNA, plasmid DNA, and mRNA), both for our internal projects and programmes, as well as client specific requirements. He/She will also be responsible for the validation of these methods, and transfer into regulated operations, for example, within the QC department.
The successful candidate will report directly to the Chief Operating Officer.
While not exhaustive, the following is a sample of the responsibilities for the role:
- Provide strategic leadership and technical expertise to identify, develop and qualify/validate methodology suitable for the phase appropriate characterisation, release and stability testing of both internal and external nucleic acid-based products (pDNA, dbDNA, mRNA), in line with regulatory expectations;
- Participate in discussions with clients regarding specific analytical method development requirements;
- Perform routine analytical research activities;
- Troubleshooting related to analytical methods, stability studies, and investigations of anomalous results;
- Technical and quality oversight of outsourced analytical development, characterisation and validation activities undertaken by selected analytical suppliers;
- Preparation and review of Specifications, Method of analysis procedures and Analytical development reports;
- Supporting the selection of suppliers including the identification of appropriate technical providers and the generation of initial quality assessments;
- Preparation of analytical technical documents for dossier, method transfer, and submissions of projects, for both internal and client projects;
- Assisting in establishment of infrastructure (Analytical equipment’s qualification, validation, and preparation of SOPs);
- Undertake trend analyses to ensure the consistent ongoing performance of relevant analytical methods;
Skills and Experience
- Substantial working experience in analytical development for Biologics or nucleic acids (7+ years desirable) in a CDMO environment
- Extensive Experience in a GMP Regulated, Pharmaceutical industry
- Strong conceptual, analytical development and validation skills
- Experience in drafting analytical documents for regulatory submission
- Ability and track record of successfully working in cross‐functional teams to progress projects
- Previous line management responsibilities
- Bachelor’s Degree in the following fields of study: Biology, Biomedical Engineering, Biotechnology, Biochemistry, Chemical Engineering, Chemistry
- Previous experience in a QC department desirable
Apply for this role by emailing a CV and tailored cover letter to TDSjobs@touchlight.com, clearly stating the reference “Head of Analytical Development”.
Please note that we will only contact those who we invite to interview.