Manager, Biochemistry Laboratory:
Merck

QUA006858-en_US
Merck
Durham North Carolina
Pharmaceutical
Description
Requisition ID: QUA006858

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. 


As part of Merck's Quality Operations Organization, the Durham site Quality team is seeking a highly motivated individual as a Lead for BioAssay/Biochemistry Laboratory.

The Quality Operations Laboratory Lead will be assigned primarily to support cell-based analytical methods, including potency and biochemistry assays. The successful candidate will have a critical role during the investigation of laboratory atypical events and quality notifications.

  • Management of Laboratory Personnel
  • Extensive knowledge in biochemistry assays performing a broad range of techniques such as enzyme assays, moisture testing, and compendial tests in order to support in-process, release and stability testing.
  • Provides leadership on a daily basis to ensure routine testing is performed within defined turnaround times.
  • Maintains high-level technical expertise for the areas of responsibility.
  • Maintaining labs in an inspection-ready, GMP-compliant state and represent the laboratory as SME during audits and inspections (regulatory, internal, safety). 
  • Lead a team with continuous improvement initiatives that reduce costs, improve quality and enhance the contribution of the analytical team.
  • Supports MMD divisional and Quality initiatives.
  • Participates in strategic planning for customer needs.

Qualifications

Requirements:
-     B.S.degree in a science field, preferably biology, microbiology, or biochemistry
-     Minimumof 7 years’ experience demonstrating increasing responsibilities inpharmaceutical industry supporting a GMP manufacturing facility
-     Minimumof 4 years of experience in direct people management
-     Mustpossess the ability to work independently, manage multiple priorities andinterpret a broad range of policies, procedures, and regulations to ensureregulatory compliance
-     Demonstratedinvestigation and technical writing skills, and high attention to detail.
-     Musthave ability to work with team members on and off-site
-     Experiencewith presenting and interacting with regulatory inspectors
-     Experiencein analytical assay development, method validation and method transfers;development of validation strategy and regulatory filings for analyticalmethods
-     Demonstratedknowledge of Quality Systems including change control, deviations, CAPAs andtraining
 
Preferred:

-     Advanceddegree in Biological Sciences or related fields
-     Highlyskilled in diverse analytical test methods including chemistry, biochemistry,potency, cell based assays and microbiology assays
-     Experiencein Lean Laboratory methodology
-     Experiencein Lean Six Sigma methodology



 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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 



Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement