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Senior Manager, R&D Team Leader

Date: Nov 24, 2021

Location: Weston, Florida, US, 33331

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

As the Senior Manager, R&D Team Leader you will be required to have knowledge, experience and skills to manage an analytical group for an AR laboratory operation in a solid controlled release dosage pharmaceutical team, focusing on instrument/equipment validation/qualification and repair supporting release testing, raw materials testing, in process testing for finished products and the corresponding lab investigations.  The position requires demonstrated application of standard principles, theories and techniques to solve specific problems related to analytical instrument/equipment in a productive manner.


In this role you will oversee a cross-functional metrology team supporting AR laboratory operations and manage instrument/equipment validation/qualification program, repair, IQOQPQ, software validation, safety, cGMP compliance and DEA affairs. In addition you will initiate, prepare, evaluate and recommend actions regarding proposals for improved analytical instrument/equipment upgrades and purchases.


Other duties:

  • Participate in budget planning including capital equipment budgets. Propose capital purchases and execute purchases.
  • Manage a fiscal budget to qualify analytical instrument/equipment in AR laboratory.
  • Manage inventories of reference standards, reagents and laboratory supplies.
  • Identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols and reports.
  • Support AR laboratory investigations related to instrumentation failures, compliance and audits.
  • Manage and collaborate effective teamwork to support finished products, raw materials and in process testing of solid controlled-release dosage products.
  • Maintain compliance with applicable FDA, EMA, Health Canada, ICH, GxP, DEA and safety regulations.
  • Actively contribute to the maintenance of a clean, safe working environment in the laboratories.
  • Conduct internal audits and implement compliance programs related to cGMP, Data Integrity  computer application security and CAPA. 


This role will require you to be able to stand, stoop, sit and potentially lift materials and supplies weighing up to 50 pounds for extended periods of time throughout the day.
 

Qualifications

 

What you will bring to the role:

  • Bachelor’s degree in Analytical Chemistry, Biochemistry or other life science related field of study
  • Minimum 8 years of experience in laboratory operations within the pharmaceutical industry 
  • Minimum 3 years of supervisory/management experience
  • Minimum 8 years of experience with safety, cGMP compliance, data integrity, DEA and FDA regulations


Preferred Qualifications:

  • Able to prepare regulatory audits such as PAI and GMP inspections from FDA, European Medicines Agency (EMA), Health Canada and other regulatory agencies.
  • Scientific knowledge/experience with analytical instruments and the ability to troubleshoot, and provide direction to resolve issues related to instrumentation
  • Scientific knowledge/experience with analytical instrument/software qualification and report review
  • Proficient in Microsoft Office, PC applications and application software such as Empower 3, SAP, Trackwise Harmony, Livelink etc.
  • Knowledge and experience with lab investigation and report preparation

Function

Research & Development

Sub Function

Drug Development and Preclinical Studies

Reports To

Director, Analytical R&D

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami