Team Leader, Dpd - Ware, United Kingdom - GSK

GSK
GSK
Verified Company
Ware, United Kingdom

4 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

Site Name:
UK - Hertfordshire - Ware RD


Posted Date:
Jan


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 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 projectspecific 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 preclinical animal & prePoC 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 projectspecific 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.
  • 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 preformulation 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 a
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