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Associate Principal Scientist - Biologics and Vaccine Analytics

Merck


Location:
West Point, PA
Date:
08/16/2017
2017-08-162017-09-15
Job Code:
BIO004827
Merck
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Job Details

Job Title: Associate Principal Scientist - Biologics and Vaccine Analytics  - BIO004827

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 ad Vaccine analytics (BVA), part of Merck Manufacturing Division (MMD), is responsible for analytical activities supporting commercialization of vaccines and biologics from Phase III through launch and transfer to supply as well as in-line analytical support to enable world-wide robust vaccine and biologics availability. BVA supports process development, optimization, late-stage and life-cycle management activities, including interfacing with a network of facilities for product manufacturing and testing, analytical optimization, assay validation, analytical technical transfer, BLA filing documentation, troubleshooting and interfacing with national regulatory authorities.

 

Responsibilities of the Associate Principal Scientist will include and are not limited to the following:

  • Responsible for interfacing across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of vaccine analytics.
  • Will coordinate with analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and transfers between Merck, external partners and CMO/CROs.
  • Experience in analytical development and quality control (QC), with a working knowledge of current Good Manufacturing Practices (cGMP).
  • At any given time, could be responsible for contributing to and coordinating analytical activities across multiple projects.
  • Will also lead cross functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes.
  • Develop and optimize cell-based, microbiological, immunochemistry-based analytical methods.
  • Prepare and execute analytical method transfers and assay method validations - write and coordinate review of protocols and reports.
  • Provide on-going support to internal and external partners to resolve analytical issues and trouble-shooting.
  • Assist in the development and execution of critical reagent qualification protocols and stability studies.
  • Assist with the technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.
  • Contribute as author to regulatory submissions.
  • Oversee individual contributors as appropriate


Qualifications

Education Minimum Requirement:

 

Required: B.S. in Biochemistry/Biological Sciences or equivalent

Preferred: M.S. in Biochemistry/Biological Sciences or equivalent

 

Required Experience and Skills:

 

Minimum of (5) years relevant Late-Stage Industry experience

Demonstrated strong technical background in Assay Development, Validation, Technical Transfer, and Trouble-shooting

Experience preparing and executing Assay Validation and Transfers Protocols and Reports

 

Preferred Experience and Skills:

 

Demonstrated Organizational and Project Management skills

Demonstrated oral and written communication skills.

Ability to work independently with minimal supervision.

Ability to rapidly establish and lead teams and successfully collaborate across functions and departments.

Effectively identify and communicate risks

Strong interpersonal skills and proven ability to lead cross-functional teams

 
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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