- Experience in Pharmaceutical production with significant emphases on project management, new product introduction, technology transfer experience.
- Good understanding of site operations, R&D & all related systems.
- Demonstrated experience / examples of process improvements / knowledge of QC.
- Thorough knowledge of GMPs, NIH Guidelines and validation practices.
- Line management experience required
BSc in Chemistry, Life Sciences or related discipline.
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
The Biopharm Central Testing Laboratory (BioCTL) is part of the Global Manufacturing & Supply organisation and is based on the Stevenage site. The BioCTL performs release and stability testing for a range of Biopharm clinical and commercial products including Tanzeum/Eperzan, Benlysta and Nucala. The BioCTL performs a range of physico-chemical and bioassay techniques and also provides technical expertise to the wider GSK organisation for these assay platforms. The BioCTL is a busy and dynamic department and is expanding to accommodate growth in the Biopharm portfolio in addition to continued support of existing products.
A fantastic opportunity has arisen for an experienced individual with significant new product introduction and analytical experience to manage new product introductions for BioCTL.
The role purpose will include the following;
- Focus on delivering capability and capacity for new products and technology;, delivering improvements to the existing supply chains; transfers between Biopharm & R&D; and managing regulatory commitments.
- Support the new and commercialized product teams and the supply chain.
- Manage site capacity process, workload forecasting and strategic planning.
Key responsibilities include;
Develop and own site capacity processes for use in managing new product, existing projects and technical changes
- Own the development and implementation of allocated NPI/Capex projects including feasibility study, laboratory design and selection, EHS studies, commissioning and validation in order to grow the BioCTL business.
- Deputise for Operations Director in Supply Chain and R&D forums.
- Develop and maintain relationships with key global R&D/GMS groups to influence strategies for future process development and technology transfers
- Lead evaluations of potential fit of prospective new products into BioCTL (e.g. SIAs, RFI responses)
- Build and maintain trusting relationships with global customers, team members, peers and superiors
- Ensure that all assigned technical transfer teams (TTT) are being effectively managed at site level and projects teams, CTL have clear and properly aligned objectives / goals.
- Manage the people assigned to their new products ensuring they are trained in the appropriate procedures for technical transfer, validation and regulatory requirements. Ensure appropriate guidelines, policies etc., pertaining to existing and new product introduction are utilized and followed.
- Ensure the interface between all teams involved in projects and are clearly defined and managed to ensure rapid and efficient new product introduction on the site and on-going success.
- Ensure an effective knowledge handover of the NPI to the BioCTL team occurs at the appropriate time as defined by the Technical Development and Analytical Team Plans.
- Manage any outsourcing activities
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Closing date for applications: 20th August 2017
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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