Vaccine Seed Management Specialist:
Merck

REG003553-en_US
Merck
Elkhorn Nebraska
Pharmaceutical
Description
Requisition ID: REG003553

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 Vaccine Seed Management Specialist position is available at the Merck Animal Health facility in Elkhorn, Nebraska, located on the West end of Omaha.  The Elkhorn facility is expanding operations to manufacture animal vaccines and biologics. Looking for a talented individual to join our Analytical Technical Support team using key technologies for cell culture, filling and packaging. 


The Analytical Tech Support (ATS) group supports International Vaccine Seed Management (ISM).

The Vaccine Seed Management  Specialist, ATS is responsible for but not limited to the following:

  • Subject Matter Expert (SME) for seeds in the US region. Responsible for support and advice for US biological groups (R&D, Merck Manufacturing Division-MMD, Regulatory Affairs-RA, BTS) for production and testing of seed materials; provide technical direction to ensure compliant production seeds are produced in US region (including seeds for EU/global)
  • Coordinates Master Seed testing in the US region; includes advice on raw materials, volumes, containers, labels, storage, and testing specification for all Master Seeds produced in US region, consulting with SMEs from BTS, R&D, RA, and Quality.
  • Supports harmonized approach with Global seed management for all US seeds according to Global Seed Management Policies/Guidelines
  • Support Divisional auditing teams during audits on adherence to Global Seed Management policies on US sites as appropriate
  • Supports US Reference Management which may include, but is not limited to bench level testing, technical direction for R&D reference stability protocols, date file preparation, interpretation of statistical analyses, and report preparation to communicate stability results with regulatory authority

Qualifications

Education:
  • Bachelor’s Degree in a Relevant Biological Area (Bacteriology, Biochemistry, Biology, Genetics, Immunology, Microbiology, Virology)
Required:
  • Minimum of 3 years animal health industry experience
  • Project management and product investigation experience
  • Expanded knowledge in at least one biological area, experience in other biological areas
  • Experience leading cross-functional teams
  • Proficient in technical writing and use of Microsoft programs (Excel, PowerPoint, Word)
  • Excellent communication, interpersonal, and organizational skills
Preferred:
  • Experience in biological testing and/or biological production processes
  • Seed management experience desired, but not required
  • Knowledge of USDA requirements for managing reference stability and extraneous agents testing
  • Experience preparing and interpreting basic statistical reports desired

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 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 

AHMAN2017



Job: Regulatory Compliance
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement