Job Detail

JOB DESCRIPTION

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Our Company is seeking an exceptional candidate for a technical leadership position within the Analytical Sciences – Science and Technology (S&T) 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 global supply operations.

The incumbent will be expected to interact closely with the external Contract Manufacturing Organization sites (CMO’s) across the Manufacturing network in identifying, developing, implementing, and troubleshooting laboratory test methods, technologies, and workflows as well as material for ensuring compliant, robust, and responsive supply. The candidate will have a deep understanding of the technical, regulatory, and business environment needs related to API (and/or Drug Product) development and commercial supply, GMP compliance in commercial manufacturing, and data integrity as well as provide critical analytical support to ensure success.

Primary responsibilities include:

• Author analytical procedures, methods development, and validation protocols and reports, technical reports, erxperimental designs, regulatory submission documents, etc.




• Perform investigations with strong technical troubleshooting skills and assist in developing/implementingCorrective Action and Preventive xAction (CAPAs)




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




• 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 cross-company communication to influence implementation strategies




• The position will report to the Director of External Manufacturing (ExM) API.




• 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 sustained, compliant supply of products to our patients.

Education:

• Ph.D. degree with 6+ years or BS/MS degree with 12+ years of experience in analytical development or commercial supply support for API and/or drug product

Experience and Skills:

• Knowledge of API and Drug Product commercial quality control testing




• Knowledge of various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and the application of specifications to support drug substance and drug product development and registration




• Knowledge of the process by which the products are brought to and maintained on the market




• Experience working with CMO’s and CRO’s




• Working knowledge of CMC filing requirements




• Working in cross-functional teams




• 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, raise issues, and help to drive to resolution




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

Preferred Experience and Skills:

• Experience leading cross-functional teams

#NewCo

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

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

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R90875