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Associate Principle Scientist - Supply Analytical Sciences

Merck


Location:
West Point, PA
Date:
06/22/2017
2017-06-222017-07-22
Job Code:
CHE005384
Merck
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Job Details

Job Title: Associate Principle Scientist - Supply Analytical Sciences  - CHE005384

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

 

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

 

Merck is currently seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization.  The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical troubleshooting to driving lead time reduction and efficiency gains in support of Merck’s World Class Supplier (WCS) and Operationalizing Quality goals. The incumbent will be expected to interact closely with internal and external sites in Merck Manufacturing network in identifying, implementing, and troubleshooting laboratory test methods and workflows as well as material for ensuring compliant, robust, and responsive supply. The individual will have a deep understanding of the regulatory and business environment and needs related to API development and commerical supply and provide critical analytical support to ensure Merck’s success. The individual will also be responsible for technical training of staff, as needed, on analytical techniques and problem solving. In addition, the incumbent will keep up with API and Drug Product regulation changes and facilitating central development group to make adjustment to Merck product development strategies.

 

The position will report into the SAS Americas Regional Lead. A strong technical background with a superior problem solving skill set and exceptional leadership abilities are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize Merck’s WCS vision.

 




Qualifications

Qualifications:

  • Ph.D. degree with 3 years or BS/MS degree with 8 years of analytical development experience for API and/or drug product.
  • Author analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.
  • Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
  • Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity.
  • Have working knowledge of API and Drug Product development and commercialization and understand the needs related to commercial quality control.
  • Have working knowledge of developing various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and product specification to support drug substance and drug product development and registration.
  • Have working knowledge of process by which the products are brought to market with an understanding of the roles and responsibilities of the related functional organizations within MMD and MRL.
  • Have experience working with CMO’s and CRO’s.
  • Have working knowledge of CMC filing requirements.
  • Demonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
  • Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures
  • Self motivated to take ownership and accountability of issues and drive them to completion.
  • Ability to speak up and raise issues and help to drive to resolution.
  • Ability to quickly adapt to changes and develop appropriate plans for managing risks.
 

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

 

If you need an accommodation for the application process please email us at .  

  
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
 
Visa sponsorship is not available for this position.
 
For more information about personal rights under Equal Employment Opportunity, visit:
 
           
           


Job Chemistry - Science & Technology

Primary Location NA-US-PA-West Point

Other Locations NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 2

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