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GlaxoSmithKline
,
Weybridge, Surrey
Team Lead & Principal Process Engineer
Overview
Job Description
Responsible for the process development, scale-up, and technology transfer of new products for New Product Development (NPD) projects for semi-solid and liquid Oral Care products. This position covers a broad range of challenges - from pioneering new technology routes to strengthening existing formulations, validating processes, and establishing networks of external academic collaborators, suppliers and external partners. Develops manufacturing processes at all stages of the development process, taking into account scientific and timing objectives. Will serve as the point of contact for resourcing of process development activities for new product development pipeline projects within the Scale Up Team. Key Responsibilities * Manage the manufacturing, scale-up of development batches, conduct technology transfer of new products into commercial manufacturing facilities, and implement cleaning verification/validation of process equipment as needed, to the required cGMP and Health & Safety standards * Manage the manufacture of new products at pilot plant scale to supply product for use in pivotal stability and commercial trials * Develops in-depth understanding of the new products in terms of formulation, processing, and their interactions * Write and/or review/authorise GMP-critical documentation, such as experimental reports, validation protocols, batch records, development and technology transfer reports * Lead the scale-up/down between Laboratory, Pilot & Commercial scale * Plan and implement process development experiments at laboratory and/or pilot plant scale, using agreed Operational Excellence/Quality by Design tools such as TRA and DoE. * Capable of planning, executing and delivering manufacturing campaigns within specified timeframes. Comfortable operating processing equipment and an ability to quickly learn new equipment. * Able to manage work load includin time management. * Work within multifunctional teams, building good working relationships with all parties and be point of contact for some projects whilst supporting other projects as well. * Support of equipment validation . Closing Date for Applications:19th June 2020 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV 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. 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. *LI-GSK Company Details: GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We discover, make and market life-enhancing products that are used by millions of people around the world, helping them to do more, feel better and live longer. We have 3 primary areas of business in pharmaceuticals, vaccines and consumer healthcare. We have offices in more than 115 countries, major research centers in the UK, USA, Spain, Belgium and China and an extensive manufacturing network with 87 sites globally. Our three strategic priorities are to grow a diversified global business, deliver products of value, and to simplify our operating model. Essentials: * Demonstrated experience of working within a cGMP regulated environment (Medical Device, Licenced Products) * Demonstrated ability to design, develop, and scale-up processes for Oral Care products from pilot plant scale to full scale manufacturing * Provide engineering and processing knowledge to assist in driving new innovative platform technologies into commercial manufacturing facilities * Competent at problem solving and understanding processes through applying fundamental scientific and engineering principles Prefered: * Develop scale-up/down understanding and product/process characterisation * Lead the scale-up/down between laboratory, pilot & commercial scale, developing an understanding or developing scaling rules that can be used by other engineers * Demonstrated understanding of process validation principles * Good mathematical ability - statistics and design of experiments (DoE) experience an advantage * Excellent communication and team working skills - able to interact with people at all levels from shop floor operators to Senior management * Demonstrated flexibility; ability