Product Analytical Group Leader

TEVA Pharmaceuticals USA

Location: Irvine, California-Orange County 92602
Posted on: 9/16/2009 8:52:44 AM
Postion type: Full time
Job Code: 1611339HHL
Required Education: High school or equivalent
Salary: Competitive

DESCRIPTION

Overview:

Teva Parenteral Medicines is a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity for Product Analytical Group Leader.

The position responsibilities include the development, validation, and transfer of analytical methods in support of sterile injectable dosage forms through product launch. As a technical leader within the department, the successful candidate will supervise and mentor a group of scientists in developing and validating analytical techniques related to product development, e.g. project planning and timelines, experimental design, data evaluation , formulation of relevant and scientifically based conclusions, coordinates studies with other technical groups (Pharmaceutical Sciences, Process Science). Technical presentations to senior management of experimental outcomes is expected. The successful candidate will be expected to maintain a high level of expertise within their field and develop new technologies to be applied in the testing of drug products. As a member of Analytical Sciences, the successful candidate will serve as a member of the Scientific Affairs (SA) Core Team, consulting and interacting closely with the project core group to help define analytical, formulation, and manufacturing strategies within the constraints of legal landscape requirements.

Travel Requirements

May have limited domestic and international travel.

Responsibilities:

Provide direction and guidance for the development, validation and review of analytical methods for drug, impurities, preservative and excipient in finished products and/or raw material according to time line.

Serve as an Analytical Sciences member of SA Core Teams. Evaluate, summarize and/or present technical information/data regarding specific projects to senior management, outside sites and/or Teva Global

Direct, guide and review all laboratory experiments, analyze results, data analysis, quality, accuracy and timeliness of documentation.

Lead and coordinate analytical method transfers internally and externally as appropriate.

Generate, review and assess the quality of technical documentation including protocols, SOPs, methods, reports and memos. Provide thel eadership for the preparation of analytical development section of submissions

Independently investigate and troubleshoot analytical issues

Provide technical/procedure direction and training for team members, SA Department and other departments/sites. Mentor junior team members

Lead team and/or department meetings and encourage participation to provide/exchange scientific data.

Develop and implement team and individual metrics to accomplish goals

Interact daily with peers, team members, team/departments and outside testing laboratories to ensure proper analytical testing

Follow Teva Safety, Health, and Environmental policies and procedures

Other duties, as assigned, or as business needs require.

Accurate, timely, and quality performance of all analytical activities needed for product submission, approval and launch

As a contributing member of the SA Core Team, definition and implementation of strategy for analytical development

Supervision and coordination of analytical team activities to produce high quality technical work which achieves Core Team, Department, SA and TPM goals.

Provide guidance and mentorship to team reports

Qualifications:

Ph.D. in Analytical chemistry (entry level) or Ph.D. in relevant field with 3+ years experience or M.S. degree in chemistry with 5+ years of relevant industrial experience or B.S. degree in chemistry with 7+ years of relevant industrial experience

Ph.D. in analytical chemistry

Ph.D. in relevant field with 3+ years of direct experience.

MS in Chemistry with 5+ years of direct experience

BS in Chemistry with 7+ years direct experience

5-7 years of relevant industrial experience with 2-5 years of supervisory experience

Strong knowledge of fundamental areas which apply to analytical testing techniques for evaluation and identification: e.g., HPLC, GC, surface chemistry/disperse systems, solid state properties, etc... Capable of developing and applying new technologies independently. Demonstrates the ability to provide scientific input and make decisions to resolve problems with minimal supervision.

Plans and directs project related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports. Able to work on multiple projects simultaneously

Demonstrates the ability to interact professionally and effectively with senior management, peers, team members, supervisors, outside customers; other teams/departments and other Teva sites on an ongoing basis.

Ability to gain cooperation of other functional groups within Scientific Affairs and other units at TPM (e.g. Marketing, Operations, and Quality).

Must be able to delegate and empower direct report(s) to execute objectives and deliverables.

Superior oral and written communication skills and ability to present technical information to multi-disciplinary groups.

Communicate professionally with peers, team member, and TPM and Teva Global personnel.

Must operate with a high degree of independence within Analytical Sciences. However, will need to ensure senior management is intimately informed if significant time line or problems arise during analytical development.

As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.

Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com. Click Employment Opportunities, then P

REQUIREMENTS:
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