Tech Transfer Manager
An international pharmaceutical company that focuses on ocular therapeutics is currently seeking to recruit a Tech Transfer Manager for External Pharma and Chemical Manufacturing. The organisation boasts an industry-leading portfolio of treatments that address otherwise unmet medical needs of patients worldwide. This is an exciting opportunity to work with a renowned firm that boasts two late-stage development compounds and is dedicated to providing first-class therapeutics.
- Establishing robust, efficient external pharmaceutical & chemical supply chains for successful new product launches from development through to market launch.
- Building strategies for transferring the products to contract manufacturing organizations (CMOs) for each stage of the supply chain.
- Selecting suitable CMOs and constantly maintaining relationships to ensure that the scope, execution, and reporting of predefined requirements and tasks meet project plans.
- Defining all product specific requirements such as validation, stability, and packaging as part of product target profiles and validation master plans.
- Maintaining established commercial production regarding troubleshooting, deviations/complaints, changes, and regular quality reviews.
- Ensuring that external manufacturing meets global quality standards and applicable regulatory requirements.
- Compiling specific SOPs/documentation, including regulatory documents for submissions, reviewing protocols and reports for completeness, and overseeing cGMP compliance and acceptability of data.
Skills and Requirements:
- University degree from a scientific field, preferably in a pharmaceutical & chemical environment.
- At least 3 years' experience in pharmaceutical & chemical manufacturing (preferably in aseptic filling), with working knowledge of manufacturing processes, validation, and change control concepts.
- Excellent understanding of FDA, EU, and ICH cGMP guidelines, and industry best practices.
- Expertise in validation, qualification principles, and standards with demonstrated ability to apply these to GMP operations.
- Ability to solve problems, work in multi-disciplinary teams, exhibit excellent interpersonal skills and prioritize multiple tasks.
- Experience in the compilation of relevant procedures, protocols, reports, and regulatory submissions documents.
- Proven history of working with several CMOs and ability to define key selection criteria.
- Willingness to spend 20% of time travelling globally.
- Fluent in English, German is a plus.
- Demonstrable project management skills.
- 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 Chidozie Orji at +44 207 440 0671 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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