Associate Principal Scientist - Global Supply Analytical Science Job - United States
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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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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 located at Rahway, US. 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 regulation changes and facilitating central development group to make adjustment to Merck product development strategies.
The position will report into API Development. 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.
- Ph.D. degree with 3+ years or BS/MS degree with 8+ years of analytical development experience for drug product or drug substance.
- 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 development and commercialization and understand the needs related to drug product.
- Have working knowledge of developing various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and product specification to support drug substance 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.
- API Development and Supply experience
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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Job Title:Assoc Prin. Scientist, Chemistry
Primary Location: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Yes
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Analytics, Scientific, Law, Chemistry, Supply, Management, Engineering, Legal, Science, Operations