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Laboratory Manager

Date: Mar 11, 2019

Location: Runcorn, GB, WA7 3FA

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

 

Teva’s Steriles Device Team (SDT), based in Abbots Park, Runcorn, develops needle-based injection devices for delivery of Teva’s sterile liquid medications.  Our broad portfolio of both generic and specialty medicines covers a variety of device technologies, Pre-Filled Syringes (PFS), pen injectors and autoinjectors, for the treatment of a wide range of diseases, including anaphylaxis, migraine and diabetes.


The two main aspects of the SDT Laboratory Manager’s role are:

 

• Manage the SDT Laboratory - leading a team of skilled scientists and technicians, overseeing the development of the necessary procedures & test methods, managing the delivery of device characterisation, investigation and verification for our internal and external stakeholders.

• Manage the SDT Workshop – leading a highly experienced workshop team developing bespoke laboratory fixtures and device prototypes to support the SDT Laboratory and the wider SDT team.

 

With both parts of this role there are organisational & technical challenges to overcome, problems to investigate and solve, innovative solutions to develop and implement.  Through the services that the laboratory and workshop teams provide and the ideas that they create, the Lab Manager contributes directly to the development of innovative devices and new primary pack technologies.  In addition, the SDT Laboratory Manager manages outsourced services for the laboratory and workshop and supports the provision of an integrated approach to device testing with laboratories at Teva’s other sites, including the transfer of test methods to commercial production sites.

 

Key Responsibilities

 

  • Direct line management responsibility for the laboratory sub-team leaders (2) and workshop team (2).
  • Managing the provision laboratory services (characterisation, investigation and verification of devices) to meet the needs of SDT’s device development projects.
  • Understanding and managing stakeholder’s expectations, both internal (e.g. SDT Project Managers) and external (e.g. laboratories at Teva’s manufacturing sites who receive the transferred test methods).
  • Planning and allocating internal resources to projects.
  • Where necessary, selecting and managing external suppliers to supplement internal resources.
  • Responsive to changing business priorities and project needs.
  • Ensuring that the necessary equipment and consumables are available.
  • Ensuring that all equipment is maintained and calibrated according to manufacturer’s schedule.
  • Ensuring that any bespoke fixtures are designed, manufactured and validated for use.
  • Ensuring that suitable test methods have been developed and validated.
  • Providing and maintaining suitable cGMP procedures and working practices to ensure the safety, efficiency and quality of the Laboratory and Workshop.
  • Ensuring adherence to standard operating procedures.
  • Identifying and implementing opportunities for continuous improvement of procedures and ways of working.
  • Ensuring that the Laboratory and Workshop are well prepared for audits (for both internal and external audits).
  • Ensuring that Computer Systems Validation (CSV) is completed for new equipment and procedures and is maintained for existing systems.
  • Management of the Laboratory & Workshop CAPEX and OPEX budgets.

Qualifications

 

  • Graduate in Physics, Engineering or related subject, or equivalent.
  • Demonstrable experience in management of a workshop and/or evaluation team.  Experience of applying problem solving tools.
  • Proficiency in the 3D CAD Design Tools and design detailing.
  • Time Served Apprentice in tool making / similar preferred.
  • In-depth knowledge (through practical experience) of GMP, EU and FDA regulatory requirements.
  • Understanding of rapid prototyping.
  • Design for development and manufacture – functional and assembly.
  • Understanding of device development and manufacturing processes.
  • Understanding of device and drug/device combination regulatory requirements.
  • Sterile product development knowledge (through experience).
 

Function

Project Management

Sub Function

RandD

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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