Job Description

Who we are

Together, we\'re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It\'s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world\'s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization\'s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we\'re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Under the direction of Sr. Manager, Analytical Development Specialist performs typically complex and highly specialized tasks pertinent to analytical method development, QA investigation including foreign matter and unknown impurity structure elucidation, physical analysis that require a broad theoretical and practical knowledge base, critical thinking and reasoning, excellent problem exploration and solving skills as well as the ability to critically appraise data and make sound judgment.

How you\'ll spend your day

Method development and method revision to improve QC productivity and efficiency

• Performs highly complex and specialized method development and method revision tasks that require a broad knowledge base, extensive hands-on experience and independent critical judgment.
• Operates and troubleshoots analytical laboratory instruments such as HPLC, UPLC, GC, Malvern Particle Size Analyzer, Dissolution Apparatus, ICP-MS, LC-MS etc.

Performing QA investigations and solving complex problems to support QA\'s CAPA commitment.

• Utilizes excellent problem-solving skills to solve complex and difficult problems that require comprehensive inquiry or research.
• Performs QA investigations including identification of foreign matter (black specks), customer complaints investigations, QDR or OOS investigations and commercial product failure investigations.
• Assists the supervisors/managers on an ongoing basis to tackle problems that often require innovative approach to finding solutions.

Performs complex material characterization testing to support supplier driven material changes, Alternative API sourcing and critical product investigation.

• Performs method development and validation for particle size analysis.
• Conducts material characterization analysis and data interpretation with various techniques such as Malvern PSD analyzer, FTIR, Image analyzer, SEM, LC-MS etc.
• Reviews API suppliers\' technical packages or open part Drug Master Files.
• Evaluates the physical and chemical properties of the API and determines the suitability of the alternate API to be used in the drug product.
• Plans and performs required experiments including additional method development/validation when required. Proposes and justifies the changes to the current specifications.

Support Compendial Update Review.

• Reviews detail of compendial updates for impacted products.
• Evaluates and Identify gaps.
• Provides inputs as a SME on strategies for closing the Gaps.
• Supporting QC staff in technical training and troubleshooting.

Provides advice, assistance and training to QC staff as required to improve technical skills and overall productivity. Helps in the troubleshooting.

• Works independently with responsibility to accommodate frequently changing priorities. Performs other duties as assigned.
• Performs other related duties as required.

Your experience and qualifications

Education: University Degree in Chemistry or a related science. Preferred: MSc or PhD in Chemistry or a related science is preferred

5 Years Laboratory Experience in the related field
In depth knowledge of:

• Method validation fundamentals and requirements
• Solid understanding of pharmaceutical formulation and material characterization
• Technical requirements as per compendia (USP/NF,BP/EP), in- house methods and general QC laboratory procedures
• Analytical laboratory equipment common in QC Lab environment (HPLC, UPLC, GC, Dissolution & Particle Size etc.).
• Knowledgeable in ICH guidelines, GMP/cGMP regulations as they apply to the laboratories.

Demonstrates excellent written and verbal communication skills in order to:

• Interpret analytical data and discuss the issues/problems with the supervisor and peers if required.
• Write in a lucid format, General lab procedures, SOPs, validation/method transfer reports and other relevant QC documents

Good computer skills with proficiency in Microsoft Office, Labware LIMS, SAP, navigating online compendia publications,

Good knowledge of QA business processes and RA business processes. Good understanding of:

• Analytical methods and techniques common to QC Lab
• GMP, cGMP and other regulatory requirements
• Key measurements to support business related to customer service

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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.

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