Contract Clinical Trial Manager
A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Technical Director. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's UK office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
- Leading the work of all technical contributors within EMO.
- Building a competent and agile Technical function in support of the company's varied portfolio of externally manufactured products.
- Ensuring that technical expertise is provided across the broad spectrum of products including biologics, small molecules, radiopharmaceuticals, oral formulations, injectable formulations, aseptic filling, and devices.
- Building strong relationships with the company's global internal and external network of technical experts.
- Leveraging support from other Technical Operations teams as and when required.
- Establishing a strong technical credibility with Alliance partners, CMOs and CTLs, and provide support to Third-Party Subject Matter Experts (SMEs) in technical problem resolution.
- Ensuring all activities relating to products and projects are risk assessed to ensure the best possible outcome.
- Driving and supporting technical business processes using EE tools and techniques.
- Providing technical writing support for Regulatory CMC activities, including:
- authoring/reviewing Drug Substance & Drug Product Module 3 sections of submissions (licences, variations);
- authoring/reviewing of responses to regulatory agencies requests for supplementary information;
- authoring/reviewing of briefing documents in support of Agency meeting requests and questions;
- Participate at scientific advice meetings with the Health Authorities (FDA, EMA, National Agencies).
- Overseeing analytical activities (DS/DP release testing, stability studies, reports, trend analysis, etc.).
- Maintaining analytical data and trending.
- Ensuring the maintenance of a good relationship and know-how with contract laboratories.
- Proposing simplification and rationalisation efficiencies for sampling and testing whenever possible.
- Ensuring that all technology transfers are carried out in accordance with the company's business requirements.
- Acting as the External Manufacturing team's primary point of contact with SMEs at CMOs/CTLs.
- Authoring and/or reviewing key master documents (plans, protocols, reports) to support Technology Transfer activities involving CMOs.
- Educating the EMO team in the technical field through formal and informal knowledge dissemination.
Skills and Requirements:
- Degree in a technical discipline related to life sciences (e.g. biochemistry, chemistry, (bio)chemical engineering, pharmaceutical technologies). A PhD is preferred.
- At least 10 years' hands on experience in development, manufacture, and testing of Drug Substance and/or Drug Product, including a solid experience in technology transfer of manufacturing processes.
- Management of teams at Manager Level.
- Dual Drug Substance and Drug Product development or manufacturing experience preferred.
- Recognised Subject Matter Expert in at least two of the following areas:
- Biologics Drug Substance manufacture and testing.
- Small molecule Drug Substance manufacture and testing.
- Sterile Injectable Drug Product manufacture and testing.
- Solid Dosage form Drug Product manufacture and testing.
- Ability to learn quickly, and to apply consistently sound scientific principles to resolve technical problems in unfamiliar fields of knowledge. Proficient in problem solving and root cause analysis methodologies.
- Experience using statistical process control and process analytics for evaluating and controlling cGMP manufacturing operations.
- Extensive experience in EU, US and major ROW application of cGMP, GLP, GDP, ICH regulations and international regulatory guidelines.
- Knowledgeable in process, analytical methods and cleaning validation applied to the manufacture of active pharmaceutical ingredients and medicinal products.
- Significant experience in technical authoring of sections of CMC Regulatory files for commercial products (NDA/BLA, MAA, variations).
- Knowledge of CMC Regulatory requirements for Biologics.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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