Associate Principal Scientist-Biologics Analytical Technology:
Merck

BIO005072-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: BIO005072

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. 


We are seeking a highly motivated and experienced Scientist to join the Biologics Analytical Technology group in West Point, PA.  The position is within Biologics and Vaccines Analytics and provides technical support for analytical methodologies used in testing of large molecule products.  These responsibilities encompass bioassays, including immunoassays and cell-based assays, for in-line products as well as late-stage pipeline programs.  The group’s overall objective is to develop and maintain robust bioassays that ensure product supply and safety.


Primary responsibilities of this position include, but are not limited to: 

  • Performing basic theoretical and experimental scientific and technological investigation directed toward the acquisition of new knowledge, specifically related to new bioanalytical technologies
  • Provide authorship or review of analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs and regulatory submission documents.
  • Contribute to investigations with strong technical troubleshooting skills and assist in developing/implementing Corrective and Preventive Actions (CAPAs).
  • Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.

Qualifications

Education: 

  • Masters Degree with a minimum of eight (8) years of experience in Pharmaceutical Sciences, Biochemistry, Bioengineering, Biophysical Chemistry, Chemical Engineering, or related fields -OR- PhD with a minimum of four (4) years of experience in Pharmaceutical Sciences, Biochemistry, Bioengineering, Chemical Engineering, Biophysical Chemistry or related fields of experience 

Required: 

  • Direct experience with commercial monoclonal antibodies and/or therapeutic proteins 
  • Working knowledge of developing various bioanalytical techniques (e.g., ELISA, SPR, functrional cell-based assays) to support drug substance and drug product development and registration. 
  • Have experience working with CMO’s and CRO’s.
  • Strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
  • Strong interpersonal skills with flexibility and sensitivity in dealing with different cultures
  • Self-motivated to take ownership and accountability of issues and drive them to completion.
  • Ability to speak up, raise issues, and help to drive to resolution.
  • Ability to quickly adapt to changes and develop appropriate plans for managing risks.

Preferred: 

  • Experience with Quality and Regulatory Requirements
  • Working knowledge of data integrity and recent industry trends
  • Working knowledge of CMC filing requirements.
  • Experience with Critical Reagents associated with analytical testing.
  • Experience with Life Cycle Management of analytical methods.

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:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement