Senior Specialist, Product Development (LSDPD)

Boehringer Ingelheim    North Brunswick, NJ
Job Description
Responsible for implementing experiments directed towards optimizing and characterizing process parameters and conditions for the development of manufacturing processes.
Responsible for the efficient manufacture of clinical supplies and development batches of new veterinary pharmaceutical products in compliance with regulatory and quality expectations. Responsible for handling of Domestic and Global Clinical samples and Reference standards.
The incumbent provides data, process information, and materials contributing to the attainment of Department and BI Animal Health research objectives.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim s high regard for our employees.
Duties & Responsibilities:
  • Monitors and maintains pilot process performance, partnering with applicable resources to ensure all key performance indicators are met. Maintain the control and monitors stability of the processes ensuring critical process parameters are being met.
  • Manages the pharmaceutical process and equipment in a ready state involving cleaning, setting up and operating to produce quality product in compliance with cGMP, safety and environmental regulations as required. Report Equipment and Site related problems to Site ops for Corrective actions.
  • Partner with Quality Assurance, Site Operations, and Project Team members as necessary to resolve chemical process issues ensuring all documentation and changes are captured, communicated and trained to as appropriate.
  • Prepares and execute, experimental and GMP batch records in accordance with Batch evaluation and stability protocols and provides accurate, summarized information and data for reports.
  • Manages clinical and Reference standard supply.

  • Bachelors degree from an accredited institution in Pharmacy, Chemistry, Chemical engineering or related field, with zero to two (0-2) years of relevant experience, or Associates degree from an accredited institution with a science, technology, engineering or math concentration, with a minimum of fifteen (15) years of relevant experience.
  • Requires good communication skills and will be detail oriented.
  • Requires demonstrating the ability to effectively interact with a wide variety of people and disciplines and being able to work independently and proactively with minimal supervision.
  • Successful candidates will be detail oriented and have a knowledge of pharmaceutical equipment or manufacturing as well as an appreciation of cGMP’s.
  • Requires an understanding and adherence to cGMPs in the production of clinical and registration batches and adherence to meeting EU and US Regulatory expectations in the development of finished product processes.
  • Physical Demands / Surroundings:
  • Lifting, carrying, pushing and pulling – <25 pounds occasionally
  • May require extended periods of sitting. Walking and standing occasionally
  • Climb stairs frequently. Bending/stooping and twisting occasionally
  • Writing frequently.
  • Periods of use of personal protective equipment, including respiratory protection. Facial hair may not interfere with respiratory equipment.
  • Periods of physical activity in work environments of high or low temperatures and/or high or low humidity occasionally
  • Visual / Hearing Demands: Contact lenses are allowable. May require extended hours at a computer screen. Must be able to read electronic documents of all types. Depth perception and hearing acuity required.
  • Work is primarily at the North Brunswick site but may also be required to travel nationally or internationally.

Eligibility Requirements:
  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.Want to learn more? Visit and join us in our effort to make more health.Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.
Job - Research & Development Primary Location - Americas-US-NJ-North Brunswick Organization - US-Boehringer Ingelheim Animal Health Schedule - Full-time

Sat, 09 Nov 2019 01:32:24 GMT

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