API Technical Specialist

TEVA Pharmaceuticals

North Wales, Pennsylvania

Overview:
Teva Pharmaceuticals USA is the leading global generic pharmaceutical company employing 27,000 people worldwide. The company's aggressive growth strategy has positioned Teva as a top 20 global pharmaceutical company with plans to be Top 10 in the coming years. Teva is the largest manufacturer and distributor of pharmaceuticals in the world.

Responsibilities:
The API Technical Specialist will coordinate technical, legal, quality, and operational API issues for Generic R&D. Work with Global Sourcing, Legal, and external suppliers/agents to assist with API supplier selection and strategy development. Keep stakeholders informed of key issues, potential challenges, and significant delays. Provide information, options, and recommendations for risk management decisions.

Essential Responsibilities:

• Lead API strategy discussions, ensuring stakeholders understand timing, costs, risks and alternate options.
• Provide Global Sourcing with technical, legal, and quality requirements to select a viable primary and standby source.
• Maintain system to coordinate API planning/ordering, budget/control, and group decision making.
• Anticipate supplier challenges, ensuring a timely switch to a stand by source when required to meet submission targets.
• Obtain technical information and samples from suppliers for evaluation and development requirements.
• Initiate process patent reviews with Legal, ensuring on-time clearance of API process and API in final drug product.

Primary Outcomes:

• On-time delivery of acceptable API for development and submission.
• Provide Generic R&D with a clear understanding of options and risks for optimal decision making.

Qualifications:

• Background knowledge of physical-chemical properties, polymorphism, particle size, purity, and related analyses.
• Strong communication skills with intense follow through on simultaneous issues.
• Ability to maintain working relationships and a sense of urgency with suppliers and agents.
• Background knowledge of legal standards such as claim construction and doctrine of equivalents.
• Background knowledge of formulation including excipient functions, processes, and platforms.

Education Required:

Bachelor's degree in a scientific field or equivalent combination of education and related experience.

Experience Required:

3+ years of related work experience with 5+ years experience in generic pharmaceutical industry.

JOB REQUIREMENTS:
Individuals with an equivalent combination of education, training and related work experience will be considered.

Travel Requirements:

Approximately two weeks international and two weeks domestic travel per year.

To apply for this position, please copy and paste the following link into your browser address bar:
http://teva.contacthr.com/10770703
or submit your resume and salary requirements through our homepage at
http://jobs-tevapharm.icims.com/tevapharm_jobs/jobs/candidate/job.jsp?jobid=2737&mode=view

CONTACT URL: http://teva.contacthr.com/10770703
PAY TYPE: Annual
LOW BASE PAY: Competitive
HIGH BASE PAY: Competitive
PAID RELOCATION: Not Specified
CITY: North Wales
STATE/PROVINCE: PA
POSTAL CODE: 19436
COUNTRY: United States
JOB FUNCTION: Research General
JOB TYPE: Direct
REQUIRED EDUCATION: None
REQUIRED EXPERIENCE: 3 Year
TRAVEL: 0
JOB DESCRIPTION: