MS&T Specialist II

## We Are Teva We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. ## Our Team, Your Impact This position is responsible for performing activities related to critical aspects of products and processes, including process development, pre-validation and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle including validation. Executes studies with Research and Development (R D), Laboratory Technical Services (LTS), manufacturing and planning. Maintains of expertise related to formulation, raw material properties and manufacturing processes. Identifies, analyzes and suggests corrective actions to optimize procedures, processes, materials, technology and regulatory compliance issues. Provides direction and training to other staff, technicians and manufacturing operators. ## How You'll Spend Your Day

• Work with limited guidance from supervisor or seniors to drive projects to completion.
• Providing process-engineering expertise for technology transfer, from pre-validation through commercial lifecycle for modified release solid oral dosage form manufacturing including scale up, validation and lifecycle changes.
• Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies.
• Design, develop and optimize process simulation techniques for process optimization and scale up.
• Partner with internal and external groups to ensure technical success of technology transfer and continued cost effective manufacturing; provide continued technical leadership to commercial operations for various unit operations including blending, sizing, compression, coating, fluid bed processing, and novel technologies.
• Contributing to business teams through innovation, strategic input, and industry knowledge to trouble shoot and achieve cost leadership.
• Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents.
• Provide process expertise, create and update MBR and support batch record review and analysis.
• Act as a quality events investigator for assigned projects.
• Lead documentation for equipment, lead FMEAs, recommend equipment modifications as needed for validation optimization, analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
• Perform studies to support necessary equipment and system PQ's and PPQs to assure compliance in all manufacturing and support areas, analyze data using appropriate statistical tools.
• Maintain product during lifecycle (stage 3 - CPV) using appropriate statistical tools.
• Use appropriate project management tools; provide timely updates to management on the status of various projects.
• Implement and use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion - spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etcetera.
• Execute material changes, process changes, cost reduction projects.
• Provide technical training and assistance to others.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), and Standard Operating Procedures (SOP's) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

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Your Skills and Experience Education/Certification/Experience:

• Requires a Master or PhD degree in pharmacy, engineering or science with a minimum of 1 years' relevant experience in the field of Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre-validation OR related field.

A combination of education and experience will be considered.

Skills/Knowledge/Abilities:

• Understanding of various unit operations used in conventional and novel oral solid dosage manufacturing.
• Comply with FDA regulations at all times.
• Business, scientific and personal computer hardware and software applications.
• Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
• Must be able to maintain the highest levels of confidentiality, integrity and discretion.
• Excellent verbal, written, and interpersonal skills required.

## Also Good to Have ## How We'll Take Care of You At Teva, better health starts from within, and that includes you. From day one, you'll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you'll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you'll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. ## Already Working @Teva? Make sure to apply through our internal career site on Twist—your one-stop shop for career development ## 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. 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.