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Senior Manager R&D Team Leader - Fort Lauderdale, United States - TEVA CORPORATION
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Description
**Senior Manager R&D Team Leader**
**Location:** Weston, Florida, US, 33331 ****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:**
Bachelors 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, NuGenesis, (ELN), Trackwise Harmony, Livelink etc.
Knowledge and experience with lab investigation and report preparation
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.
We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.