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Principal Scientist – Biologics and Vaccines Analytics

Merck


Location:
West Point, PA
Date:
08/16/2017
2017-08-162017-09-15
Job Code:
BIO004758
Merck
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Job Details

Job Title: Principal Scientist – Biologics and Vaccines Analytics  - BIO004758

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.  Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
 
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Biologics and Vaccines Analytics (BVA), Global Vaccines and Biologics Commercialization (GVBC), Merck Manufacturing Division (MMD) is responsible for the commercialization of vaccine analytical techniques from Phase III through launch and transfer to supply as well as in-line analytical support to enable world-wide robust vaccine availability.   This team is highly motivated, fast-paced and focused on the rapid advancement of Merck’s vaccines pipeline, plus growth of existing products.  This position will influence all stages of late stage development, validation, transfers and life-cycle management of methods supporting Merck’s vaccines pipeline and inline products.  Specific job responsibilities will include analytical development, scale-up and optimization, and commercial life-cycle management of analytical strategy for vaccines.

Responsibilities:
  • Lead a scientific team in the design and execution of method transfers to Merck global network of vaccines nodes. Participate locally as required
  • Interface across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of vaccine analytics. 
  • Coordinate with multiple analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and transfers between Merck, external partners and CMO/CROs. 
  • Lead cross functional teams and ensure alignment of analytical strategies with Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes.
  • Provide technical and strategic oversight to the development and optimization of molecular/cellular biology-based, cell-based, microbiological, immunochemistry, separation, all relevant analytical methods and preparation and execution of method transfers and validations. 
  • Provide on-going support to internal and external partners to resolve analytical issues and trouble-shooting. 
  • Assist with the technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.  
  • Coordinate analytical issue resolution as needed via subject matter experts within the global vaccines network. 
  • Contribute as author and reviewer to regulatory submissions including marketing applications.
  • Travel as required up to 25%


Qualifications
Education: 
  • Required: Ph.D. in molecular/cellular biology, bioengineering or equivalent bio-related science with 5 years of relevant industry experience; or M.S. in molecular/cellular biology, bioengineering or equivalent bio-related science with 7 years of relevant industry experience; or B.S. in molecular/cellular biology, bioengineering or equivalent bio-related science with 10 years of relevant industry experience
Required: 
  • Experience in the fields of molecular/cellular biology and biochemistry, including knowledge of several of the following techniques:
    • Bioassay
    • Viral Infectivity  assays (plaque/TCID50/others)
    • Plaque assay
    • Cell Culture
    • ELISA
    • PCR/RT-PCR (traditional and real-time)
    • Sequencing (traditional and MPS)
    • Separation
    • CE
    • MS
  • Minimum of four (4) years of significant GMP experience.
  • Project leadership and people management experience
  • Track record of achievement in the vaccine industry particularly in the areas of vaccines analytics.
  • Highly developed communication, team building and interpersonal skills.
  • Ability to function well in ambiguity. 
  • Knowledge of compliance and regulatory requirements in vaccines including assay validation.
Preferred:
  • Experience with Code of Federal Regulations, Quality Standards, and cGMP for CMC document preparation
  • Experience with continuous improvement or lean six sigma methodology.
Our employees are the key to our company’s success.  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.  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:
 
           
           


Job Biologics, Vaccines, Analytical Formulat

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 1

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