Director, Large Molecule Biological Critical Reagents Job

Employer
Merck
Location
West Point, PA, US
Posted
June 19 2017
Discipline
Other
Organization Type
Pharma
Director, Large Molecule Biological Critical Reagents-QUA005991

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 Director, Large Molecules Biological Critical Reagents (BCR) reports to the Vice President of Vaccines Quality and is responsible for the operation, maintenance and administration of multiple BCR hubs covering all aspects of Large Molecules. Provides direction in the development of strategic plans to ensure proper scheduling, execution, maintenance and delivery of all BCRs to ensure adequate qualification and materials are available on time every time for new product introductions and in-line products. Responsible for demonstrating operational leadership with compliance, safety, customer service, and productivity initiatives while assuring that all applicable regulatory and environmental regulations are adhered to.

Primary Activities

• Provides direction and leadership to multiple BCR hubs covering all aspects of Large Molecules.

• Directs all activities to ensure proper scheduling, execution, maintenance and delivery of all BCRs to ensure adequate qualification and materials are available on time every time for new product introductions and in-line products.

• Responsible for demonstrating operational leadership with compliance, safety, customer service, and productivity initiatives while assuring that all applicable regulatory and environmental regulations are adhered to.

• Responsible for development of the departmental budget, including headcount, spend and capital based on capacity/demand analyses.

• Ensures all laboratories and functional areas under their direction operate within the department budget and that all personnel are qualified and trained in performing the duties required.

• Ensures qualification, testing and distribution of BCRs are performed in compliance with cGMP’s and global regulatory requirements to support the quality, safety, efficacy and potency of Merck products.

• Responsible for maintenance of facilities, equipment, supplies and services and for acquiring and maintaining the necessary instrumentation and equipment required for the laboratory, including any approved capital project expansions.

• Ensures implementation of standardized and consistent work practices across all BCR hubs to ensure efficient, effective and robust processes are followed.

• Provides appropriate escalation and mitigation plans of any compliance/supply issues in a timely manner to ensure proper communication and actions are taken.

• In collaboration with the Vice President, Vaccines Quality, makes strategic decisions regarding the identification of necessary personnel resources and capital expenditures involving equipment and laboratory expansion/renovations

Qualifications

Education Minimum Requirement:

- Minimum of B.A./B.S. degree in Biology, Chemistry, Pharmacy or other related scientific discipline.

Required Experience and Skills:

- Minimum of 10 years of pharmaceutical industry experience to include a minimum of 3 years of management experience within a Quality Control Testing or Analytical Development Laboratory.

- Large Molecule Analytical experience is a plus.

- Incumbent must possess strong analytical and problem solving skills, extensive knowledge of cGMPs and the ability to make decisions in a constantly changing environment.

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 available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

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


Job: Quality Lab Related

Job Title:Dir, Quality Control

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-Pennsylvania

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck