MS&T Specialist

Who we are

The opportunity

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 process, cleaning and packaging 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

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

· Adapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, improve safety of the existing commercial products. Coordinate manufacturing of batches if required and prepare technical reports.

· Performing continuous process and cleaning verification, statistical assessments and trend analysis for the development and commercial products.

· Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs).

· Provide Technical assessments/ product impact assessment summaries on time to avoid back-order situation.

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

· Execute the experimental and process confirmation studies in coordination with planning, manufacturing, quality, LTS and PM groups.

· Review and analysis of the analytical and statistical data to support the pre-validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria: writes deviation reports and technical assessments as required.

· Supports pre-validation commercial scale report that includes detailed summary of the equipment and qualified equipment parameters (QEPs) assessment, CPPs and CQAs identified during pre-validation work.

· Identify and coordinate the equipment requirements with R & D, Engineering, Employee Health, and Safety (EHS), and PM groups in preparation of Capital Expenditure Request (CER) for the commercial scale pre-validation development/ scale up of the ANDA lots.

· Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.

· Remediation of the audit related observations (if any) and timely completion of the action items (if any)

· Maintenance of appropriate documentation of protocols, reports, and laboratory notebooks 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.

· Leading multiple new product introduction, site transfer projects and cleaning validation activities.

· 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.

Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

· Requires a college fresh Ph.D. or Master’s degree with pharmaceutical sciences or equivalent and a minimum of twelve months relevant experience in the field of MS&T solid oral pharmaceuticals.

Skills/Knowledge/Abilities:

· Ability to efficiently handle and troubleshoot pharmaceutical unit operations, such as high shear granulation, dry granulation (slugging and roller compaction), compression, particle, and tablet coating, pan coating and fluid bed coating, encapsulation, laser drill and packaging, cleaning, etc..

· Ability to prepare various types of complex high quality technical documentation (Batch Records (BR), Change Controls (CC), protocols, summary reports, technical assessments, validation reports and deviation/investigation reports etc.

· Ability to handle multiple projects, duties, and assignments.

· Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.

· CGMP, FDA, Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), DEA and other regulatory requirements.

· Scale up and post approval changes (SUPAC) in Immediate Release, Modified Release, Equipment, and formulation related changes.

· Product formulations, product stability, FDA submission methods and practices and familiarity with regulatory guidance documents.

· Controlled release dosage forms including multi-particulate systems, matrix systems, diffusion controlled and osmotically engineered pharmaceutical dosage forms.

· Pharmaceutical solids manufacturing principles, practices, and applications.

· Analytical test methodology (Blend Uniformity (BU), Assay, Content Uniformity (CU), dissolution profile, etc.

· Pharmaceutical raw material tests and raw material characterization.

Enjoy a more rewarding choice

We offer a competitive benefits package, including: 

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. 

Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. 

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. 

Life and Disability Protection: Company paid Life and Disability insurance. 

Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.  

 
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.   

Already Working @TEVA?

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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. 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.

Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.