Senior Specialist, Engineering for Analytical and Process Support in Process Development Labs Job

Employer
Merck
Location
Elkton, VA, US
Posted
October 12 2017
Organization Type
Pharma
Requisition ID: PRO016176

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 position will report to the Technical Operations Department and will initially provide process development support as part of a multidisciplinary team for an investigational drug. The candidate will have knowledge of microbial fermentation, protein purification and various analytical techniques. The successful candidate will have the opportunity to:



  • Characterize proteins with a variety of analytical techniques

  • Develop and optimize analytical methods used to support commercial manufacture

  • Modify and purify proteins at the laboratory scale

  • Provide technical/analytical support for in-line products

  • Perform/lead laboratory scale process characterization studies

  • Provide process improvement/development support for in-line products

  • Employ strong verbal and written communication skills.

  • Write and review technical documents and laboratory notebooks

  • Work both independently and within multidisciplinary teams.

  • Produce high quality work against firm deadlines

  • Author and provide input for regulatory filings
Qualifications

Education:



  • Ph.D degree in a relevant scientific discipline (Chemistry, Biochemistry, Biophysics) and up to 2 years of industry experience

OR



  • MS/BS degree in a relevant scientific discipline and 5  or more years of laboratory and/or industry experience.

Required:



  • Experience working with and purifying proteins (purification, characterization/analysis, modification).

  • Experience characterizing small and large molecules (proteins, monoclonal antibodies, viruses or virus like particles) using a variety of analytical techniques (LC/MS, HPLC, UPLC, ITC, spectroscopy, SDS-PAGE, ELISA, CD)

  • Experience in method development and method qualification / validation

  • Excellent collaborative and team-working skills

Preferred:



  • Experience working in GMP and GLP environments

  • Experience working in an industry environment

  • Experience conducting laboratory scale process characterization studies leveraging Design of Experiments (DoE) design

  • Experience trouble shooting technical issues (experimental, instrument-related issues)

  • Experience working with Waters/Empower platform for both HPLC and UPLC

  • Experience working with chromatography (AKTA/Unicorn), filtration, dialysis, centrifugation, homogenization

  • Ability to manage (prepare, run, analyze, and interpret) a large number of samples with supporting GLP/GMP supporting documentation required.

 


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 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:


 


            EEOC Poster


            EEOC GINA Supplement 



Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck