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Principal Scientist; Analytical Chemistry in Development and Supply Job

Job Details

Principal Scientist; Analytical Chemistry in Development and Supply-CHE005414

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 legacy for over a century. 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.

The incumbent is expected to lead and oversee multiple external sites (CMOs) with the focus on building strong compliance posture in product development and routine analytical testing, coach and share best practices and Merck’s expectations on analytical and product development with external partners to ensure products are meeting the regulatory requirements and are approvable. The individual will interact closely with internal MSD sites and the CMOs in Merck Manufacturing network in identifying issues/gaps and implementing solutions, and troubleshooting laboratory test methods and workflows as well as material for ensuring compliant, robust, and responsive supply. The individual will initiate and lead strategic initiatives related to technical strategies, compliance, and/or business improvements.  The individual will have a deep understanding of the regional regulatory and business environment and the needs related to API and Drug Product development, GMP compliance in commercial manufacturing and data integrity. The individual will also be responsible for technical training of staff, as needed, on analytical techniques, problem solving and data integrity. In addition, the incumbent will keep up with API and Drug Product regulation changes and facilitating central development group to make adjustment to MSD product development strategies.

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

Qualifications:

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Ph.D. degree with 6+ years or BS/MS degree with 12+ years of pharmaceutical experience.

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Author analytical procedures, method development, validation and transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents, etc.

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Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.

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Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.

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Identify and champion continuous improvement for the existing workflows.

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Have working knowledge of API and Drug Product development and commercialization and understand the needs related to commercial quality control.

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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.

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Have working knowledge of the process by which the products are brought to market.

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Demonstrate strong collaboration and influence skills with cross-functional partners both internally and externally.  

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Have experience working with CMO’s and CRO’s.

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Have working knowledge of CMC filing requirements.

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Demonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.

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Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.

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Self motivated to take ownership and accountability of issues and drive them to completion.

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Ability to speak up and raise issues and help to drive to resolution.

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Ability to quickly adapt to changes and develop appropriate plans for managing risks.

Qualifications

Education:

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Ph.D. degree with 6+ years or BS/MS degree with 12+ years of pharmaceutical experience

Preferred:

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API and/or Drug Product Development and Supply experience. Fluent in English and Korean or Chinese or Japanese

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 staffingaadar@merck.com.

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:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Chemistry - Science & Technology

Job Title:Prin. Scientist, Chemistry

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: Chemicals for analytical testing.

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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