Technology Transfer Specialist

7 days ago

Skipton, North Yorkshire, United Kingdom Dechra Full time
Summary

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.

Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

The Opportunity

We are looking for a Solid Dosage specialist to join our Technical Services team at our Manufacturing site in Skipton.

You will be expected to provide the technical support for executing new product commercialisation projects (scale-up) from Dechra PD (Product Development).

The role will also require you to provide the technical support for executing optimisation projects for currently approved products from site or from other internal sites or from CMOs (Contract Manufacturing Organisations) using product lifecycle approach, and to aide with the technical support for troubleshooting current commercialised products; new production equipment selection and significant process change.

Main Responsibilities

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

  • Support the Technical Manager and represent the department on project team level.
  • Execution of product commercialisation projects for the site (NPI and post approval changes). This will require close collaboration with Product Development, Production and QA groups on NPIs using product lifecycle approach, preparation and approval of GMP documentations to support such projects, scheduling, raw material acquisition, supervising engineering batch manufacture, etc.
  • Identifying potential process improvements for existing commercial products including proposals for formulation / process optimisation. Then support implementation of changes after management approval.
  • Provide technical support to all departments to solve problems as they occur.
  • Lead problem solving and resolution efforts in a timely, well documented manner.
  • Assist in new equipment evaluation by interfacing with the Engineering group.
  • Assist in activities for successful transfer of new equipment to production, including training of both supervisors and operators.
  • Assist in the evaluation and qualifying alternate sources of raw materials and commodities.
  • Using the Product lifecycle approach and statistics, take project leadership for the technical activities involve in the commercialisation of internal products. during Product Development, Registration, Optimisation, Validation / Launch of veterinary drug products as applicable.
  • Assist in the Technical assessment of products / projects (development and commercialised products for optimisation/site transfer).
  • Assist in implementing the product life cycle program for the site to ensure compliance with Dechra's commercialisation standards and compliance with current Global Regulatory expectations.
  • Proactively identify and troubleshoot formulation and process type issues of products manufactured internally to improve product quality and to minimize product supply interruptions.
Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are:

  • Degree in life sciences, engineering, pharmaceutics, chemistry, or similar fields.
  • Relevant work experience combined with technical knowledge, problem solving skills, sound understanding of process validation and verification, and the ability to plan and co-ordinate multiple activities.
  • This individual should be able to make competent scientific recommendations.
  • Minimum of 5 years of industrial experience in the pharmaceutical or related industry, or an equivalent combination of education and experience with knowledge of pertinent Regulatory and Industry guidance's and regulations.
  • Has demonstrated the ability to design, develop and implement effective technical transfer and product lifecycle strategies for the dosage forms manufactured by the site (solids, liquids, gels, terminal sterilisation) and a firm working knowledge of manufacturing platforms and pharmaceutical facility infrastructure.
  • Understanding of the dosage form development process, along with some knowledge of process development techniques, cGMP regulations, FDA and EMA regulations, and recent trends in product lifecycle concepts.
  • 'Hands-on' knowledge of pharmaceutical manufacturing equipment, and ability to supervise bath manufacture and instruct production operators would be beneficial.
  • Experience of the manufacture of potent products and associated containment systems.
  • Supervisory experience would be beneficial as would step-in technical managers absence.

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