• Job Description

  Req#: 386520

  Team Leader, DPD - Oral & Inhaled, UK

  Are you interested in the opportunity to lead and shape product development for our global medicines while leading a team? If so, this Team Leader, Drug Product Development (DPD) - Oral & Inhaled role could be an ideal opportunity to explore.

  The role:

  The Team Leader, DPD - Oral & Inhaled leads a team of pharmaceutical scientists and ensures the successful development of multiple drug products from Candidate Selection to file and launch with the definition and implementation of appropriate drug product development strategies in alignment with project plans. The role will lead drug product workstreams (DPWS) and/or manages DPWS leaders in their team and defines the strategy for delivery of phase-appropriate drug products.

  The Team Leader, DPD-Oral & Inhaled ensures the development of robust, reliable, phase appropriate and high-quality drug products and the associated manufacturing processes and leads transfer of drug product manufacturing processes into the commercial site(s) and supports early industrialization.

  This role leads or contributes to DPD and Medicine Development & Supply (MDS) strategies and to the establishment of discipline excellence in Formulation Development in the small molecule portfolio.

  Key Responsibilities:

  Project Delivery

  • Supervise formulation and process development scientists while serving as an active and influential member of product development matrix teams.
  • Manage the project-specific interfaces both within and outside of MDS to ensure the successful progression of project plans.
  • Use simple approaches to formulation and manufacture of drug product for supply to pre-clinical animal & pre-PoC clinical studies to enable the scientific question(s) to be reliably answered in a resource efficient manner.
  • Partner with Global Supply Chain and other MDS groups for effective integration of manufacturing activities.
  • Coordinate and/or manage project-specific external collaborations.
  • Ensure the successful transfer of the drug product formulation and manufacturing processes to the commercial site of manufacture.
  • Meet with regulators and prepare and/or review regulatory documents to allow the progression of drug products into the clinic and onto global markets.
  • Participate in the resolution of any technical issues during the clinical phase or post‑commercialization stage of development, with the goal of maintaining continuity of supply to patients.
  • Ensure appropriate application of key guidance, procedures and policies (e.g. GMP, ICH Q8, Q9 and Q12, and SOP's).
  • Ensures that timely project reviews are scheduled in conjunction with the established GSK governance process including Drug Product Line Technical Reviews.

  Safety and Quality

  Promotes Safety and Quality as values by:

  • Ensuring personal and team adherence to Company safety policy, local rules and risk assessments.
  • Participation in regular safety and quality audits.
  • Ensuring laboratory areas are maintained to good safety and housekeeping standards.
  • Ensuring personal and team safety and quality training is completed and records are maintained.
  • Ensures teams complete risk assessments and exposure monitoring exercises on their compounds.

  • Recognizes potential safety and quality problems and takes action to rectify them, including investigations and actions as required to address and prevent future incidents.
  • Approval of Master Batch Records, sampling instructions and other Quality Control procedures.
  • Review and input into appropriate product specifications.
  • Review and approval of formulation / process development reports.
  • Ensures timely, reliable recording and review of laboratory data by their teams in accordance with company policy and legal requirements.

  Communication

  • Effectively delivers oral or written reports.
  • Independently prepares and communicates recommendations for next steps, to project members.
  • Independently authors scientific papers and internal reports.
  • Independently writes/edits or approves sections for patents or regulatory submissions.
  • Presents effectively to internal GSK forums and external meetings.
  • Demonstrates networking skills through interactions across departments.
  • Responsible for sharing relevant scientific information from internal and external meetings to appropriate colleagues.
  • Ability to network with external experts in relevant areas and disciplines.

  People and Departmental Leadership

  • Create an environment that stimulates, develops, and promotes the scientific and career development of others.
  • Coach and mentor staff to help them achieve their full potential.
  • Manage performance of direct reports, develop their performance plans, conduct formal performance appraisals, and make recommendations, when appropriate, for advancement.
  • Contribute to the overall operation of the DPD department, including resource & capability planning and budget management.

  Why You?

  Basic Qualifications:

  • Honours degree in an appropriate scientific discipline. Significant track record in the product development process for oral and/or inhaled products, from pre-formulation through commercialization, and thorough knowledge of regulatory requirements (GMP requirements, SOPs and policies relevant to product development).
  • Note: The role is within the DPD - Oral and Inhaled group but applicants with significant sterile product development experience and learning agility would be considered.
  • Demonstrated capability and proven track record in science and technology driven formulation development and to understand and influence all aspects of product development.
  • Experience in the design and implementation of product development plans, with working knowledge of all preclinical disciplines as well as manufacturing and technology transfer processes
  • Thorough working knowledge of Quality by Design ability to implement appropriate strategies for projects.
  • Experience in people management and demonstrated leadership and team working skills.
  • Demonstrated ability to work with people across a company network, influence matrix teams and colleagues in other divisions and communicate with leadership and governance groups.

  Preferred Qualifications:

  • Sought out as an expert and resource in his/her scientific field.
  • Demonstrated ability to influence projects outside of own team and is recognised by his/her internal peers outside of immediate work group as an expert in a specific scientific or technical area.
  • Has knowledge of related scientific disciplines as they apply to drug discovery/development and has general understanding of key scientific areas impacting product development.
  • Demonstrates a detailed fundamental knowledge of the literature in own speciality area or scientific discipline.
  • Demonstrated proficiency in prioritizing and coordinating several areas of work.
  • Has track record of moving projects/function forward successfully.
  • If applicable, effectively coordinates external collaborations.
  • Ability to evaluate potential innovative research areas.
  • Strong written and verbal communication skills.

  Why Us?

  GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

  Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

  As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

  We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

  Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.

  Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .

  As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

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