Manufacturing Science And Technology (Mst) Specialist--Validation

Teva Pharmaceutical Industries Davie , FL 33314

Posted 4 months ago

Company Info

If you're like people at Teva, you dare to be different. We're making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry. Teva's Davie and Sunrise (Florida) production sites are two of our largest launch facilities. We are strengthening and adding to our critical teams with great talent and capabilities. Teva, a global organization, with a brand of evolving success. Be part of it!

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 a Senior MS&T Specialist, we'll count on you to:

  • Adapt Operational Excellence initiatives to improve throughput, reduce waste, improve safety of the existing commercial products. Coordinate manufacturing of additional batches if required and prepare technical reports.

  • Perform Annual Product Reviews, technical assessments, statistical assessments and trend analysis for the commercial products.

  • Perform investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions

  • Evaluate the Supplier Material Evaluation team changes such as changes to the manufacturing process of Active Pharmaceutical Ingredient or site manufacturing changes for raw materials (API, excipients) and packaging components. Coordinate the manufacturing activities and prepare technical reports.

  • Execute the experimental and process confirmation studies in coordination with stakeholders.

  • Analyze the statistical data to support the pre-validation work. Analyze data to ascertain the data meets protocol and product acceptance criteria, including writing deviation reports and technical assessments as required.

  • Support pre-validation commercial scale report that includes detailed summary of the equipment and qualified equipment parameters assessment, CPPs and CQAs identified during pre-validation work.

  • Identify and coordinate the equipment requirements with stakeholders.

  • Participate in internal (Corporate and QA audits) and external regulatory audits.

  • Remediate the audit related observations (if any) and timely complete the action items (if any)

  • Maintain appropriate documentation of protocols, reports and laboratory note books as required by Standard Operating Procedures (SOPs) and internal policies.

  • Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.

  • Lead multiple new product introductions and site transfer projects.

Qualifications

Education/Certification/Experience:

Requires a Bachelor's degree in scientific discipline

Minimum of 5 years relevant experience in the field of pharmaceutical industry

Skills/Knowledge/Abilities:

  • Ability to efficiently develop, commercialize and troubleshoot pharmaceutical solid modified release oral dosage manufacturing processes.

  • Good technical writing skills with exposure to regulatory submission documents.

  • Working experience to implement PAT for real time release

  • Excellent statistical knowledge for data analysis using statistical packages and conducting DOE using Design Expert or similar software.

Function

Manufacturing

Sub Function

Technical Transfer

Reports To

Associate Director, MS&T

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


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Manufacturing Science And Technology (Mst) Specialist--Validation

Teva Pharmaceutical Industries