Sr. Scientist, Biologics & Vaccine Formula

Employer
Merck
Location
West Point, PA, US
Posted
May 04 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: BIO005124

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’s Global Human Health (GHH) Division abides by a “patient first, profits later” ideology. Results-driven and ambitious, this team of individuals represents a functional balance between meeting company objectives and the needs of people around the world. The organization is comprised of sales and marketing professionals who are passionate about their role in bringing Merck's prescription medicines, vaccines, and other medical products to our customers worldwide. 


Biologics and Vaccines Analytics (BVA), Merck Manufacturing Division (MMD) is responsible for the commercialization of large molecule (vaccines, biologics) analytical techniques 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. This team is highly motivated, fast-paced and focused on the rapid advancement of Merck’s large molecule pipeline, plus growth of existing products. This position will influence all components of late-stage development, validation, transfer, and life cycle management of analytical methods supporting Merck’s pipeline and in-line vaccines. The selected candidate will be expected to execute analytical strategies in support both pipeline and in-line vaccines.

Responsibilities (including, but not limited to the following):

  • Execution of analytical strategies associated with method development, validation, transfer, and life-cycle management to support recombinant vaccines
  • Lead preparation and execution of analytical method validations and transfers, including authoring, approving, and coordinating review of protocols and reports
  • Author methods, SOPs and technical memos in support of projects
  • Act as a member of cross-functional teams and ensure alignment with analytical strategies and Quality Systems
  • Interface across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMOs/CROs) in the area of vaccine analytics
  • Provide timely and effective trouble-shooting of analytical issues encountered within the Merck network as well as in external partner, government, and CMO/CRO laboratories
  • Coordinate analytical issue resolution 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 20%

Qualifications

Education Minimum Requirement:

  • Bachelor's degree in biochemistry, molecular/cellular biology, or equivalent bio-related science with a minimum of 5 years of relevant experience in biologics or vaccines
OR
  • Master's degree in biochemistry, molecular/cellular biology, or equivalent bio-related science with a minimum of 2 years of relevant experience in biologics or vaccines
OR
  • Ph.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science
Required Experience and Skills**:
  • Experience with release, stability, and extended characterization testing
  • Experience developing, validating, and transferring analytical methods
  • Experience in one or more of the following techniques: immunological/immunochemical (ELISA, Western, Biacore) OR protein chromatography (SDS-PAGE, CE, HPSEC) OR spectroscopy (ICP).
  • Experience with technical writing such as SOPs and analytical methods
  • Experience representing department on cross-functional teams that support late-stage vaccines or marketed products
  • Strong organizational and project management skills 
  • Strong verbal and written communication skills 
  • Ability to work independently with minimal supervision
  • Ability to effectively identify and communicate risks
Preferred Experience and Skills:
  • 3 years working experience in the area of vaccine analytics in an industry setting
  • 3 years working experience in a GMP setting
  • Experience representing department on cross-functional teams that support late-stage vaccines or marketed products
  • Experience with CMC document preparation, including authoring and review
  • Experience with vaccine specification setting
  • Experience in interactions with US and Ex-US regulatory authorities

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 



Job: Biologics, Vaccines, Analytical Formulat
Other Locations:
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Yes, Laboratory chemicals relevent to general biochemical analyses
Company Trade Name: Merck

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