Teva Scientist II 

United States, Florida, Weston 

45644352

This position is responsible for independently planning and execution of formulation development strategies. The person functions as a subject matter expert in dealing with government agencies and external contract research organizations. Co-ordinates with other departments to get the advancement of key R&D goals.

Essential Job Functions/Responsibilities:

• Designs and conducts pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects.
• Independently plans and executes strategies for formulation development and solves complex problems.
• Conducts literature search for the projects including publications, patents, etc.
• Reviews and authorizes reports/documents such as product development reports, quality overall summary, master formulas and other key reports/documents
• Coordinate with other Teva (formerly known as Actavis or Allergan) development and manufacturing sites.
• Provides technical assessments on alternative drug delivery technologies.
• Involve in process validation when needed.
• Involve in identifying analytical testing conditions along with Analytical Development.
• Organizes and procures materials and equipment for the execution of batches.
• Conducts briefings and technical meetings for top management representatives.
• Represents Formulation Development and acts as subject matter expert with government agencies, e.g. FDA during PAI or in responding to deficiencies to submitted ANDA applications.
• Provide scientific advice and training to Junior Scientists.

This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.

Knowledge of:

• Solid understanding of pharmaceutical dosage forms including controlled release drug delivery technologies.
• Thorough knowledge of Good Manufacturing Practices.
• Knowledge of FDA regulatory guidance's, ICH guidelines and requirements of ANDA submissions.
• Knowledge of pharmacokinetics and biopharmaceutics
• Knowledge of theories, practices and principles of physical pharmacy, pharmaceutics, pharmacokinetics, biopharmaceutics and statistical designs.
• Product design of controlled/modified release dosage forms, working knowledge of multiparticulate systems, matrix systems and diffusion controlled pharmaceutical dosage forms.
• Knowledge of patents and legal requirements with relation to the development of new formulations.
• Knowledge of Quality by Design (QbD) principles and its implementation to product and process development.
• Working knowledge of Microsoft suite of software products including Excel, Word and PowerPoint.

Skills in:

• Ability to efficiently handle pharmaceutical unit operations, such as fluid bed coater, compression, roller compaction, high shear granulation, particle and tablet coating, encapsulation and packaging.
• Managing multiple projects, duties and assignments.
• Leading the activities of technical personnel; making decisions and satisfying the needs of a research program.
• Strong oral and written communication skills.
• Strong organizational skills with the ability to multi-task and prioritize assignments.
• Ability and willingness to work in a cross-functional team environment.
• Self-motivated with ability to work under pressure to meet deadlines.
• Coordinating and reviewing the work of assigned department personnel.
• Coordinating and leading multifunctional teams to ensure successful execution of projects.
• Driving for continuous process improvement.
• Strong interpersonal skills and maintaining cooperative working relationships with others.
• Innovative, realistic and practical approach to responsibilities, projects, and challenges while being results oriented.
• Ensuring compliance with all Company policies and procedures, including safety rules and regulations.

Physical Requirements and Working Conditions:

Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, lifting materials and supplies weighing up to 30 pounds, vision to monitor, and moderate to loud noise levels. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, dangerous tools and equipment. Required to wear a respirator and be able to do physical work for extended periods.

Minimum Qualifications and Experience:

• Masters in Pharmaceutical Sciences or Pharmaceutical Chemistry or related field with a minimum of 5 years of pharmaceutical industry experience in Product Development (Formulation Development) and/or process development or an equivalent combination of education and experience.
• Ph.D. in Pharmaceutical Sciences or Pharmaceutical Chemistry or related field with a minimum of 3 years of pharmaceutical industry experience in Product Development (Formulation Development) and/or process development or an equivalent combination of education and experience.
• Bachelor’s Degree in Pharmaceutical Sciences or Pharmaceutical Chemistry or related field with a minimum of 8 years of pharmaceutical industry experience in Product Development (Formulation Development) and/or process development or an equivalent combination of education and experience.

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.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
  

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