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2019 MRL Global Regulatory Chemistry, Manufacturing and Controls Intern

Requisition ID: ADM009709

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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 
Merck Research Labs is recruiting summer interns within the Global Regulatory Chemistry, Manufacturing, and Controls (CMC) group. Five internship positions are available in 2019 in the CMC group with locations in West Point, PA, Rahway, NJ and Kenilworth, NJ.  Our group strives to improve public health by enabling access to Merck medicines and vaccines worldwide.  We support every step of CMC strategy, submission and health authority engagement through all phases of the product lifecycle:  Early Development, Commercialization and Supply.
Our group is seeking summer interns interested in enhancing core knowledge and applied critical thinking skills in the regulatory CMC field including small molecule drugs, biologics, devices/combination products and vaccines. 
This opportunity will expose the intern to various areas of the department and provide beneficial experience and understanding of regulatory CMC processes:
  • Understand regulatory compliance of manufacture and release of investigational products for clinical use. Determine requirements for export/import of investigational products.
  • Understand strategies for manufacturing and testing of drug substance/drug product/raw materials in compliance with regulatory requirements.
  • Review completeness of documentation to support IND/CTA/NDA/BLA/MAA submissions (according to “refuse-to-file” guidelines).
  • Apply regulatory requirements for manufacturing /quality system and compliance with cGMPs.
  • Understand manufacturing changes to ensure compliance with appropriate change control systems/process and determine regulatory filing strategy (PAS, CBE, Annual Reports, etc.).
This is a full-time internship position. Housing subsidy is not available as part of this program and must be funded 100% by the student. Qualifications

Education:
  • Required: Candidates must be currently pursuing a minimum of a bachelor's degree in regulatory science, pharmaceutical science, pharmacy, chemistry, biomedical engineering, biological engineering, or a related field.
  • Candidates must have completed at least (1) year of study in their program by June 2019.

RequiredExperience and Skills:

  • Candidates must be available to work full-time for up to (12) consecutive weeks beginning in May or June of 2019.
  • Candidates must have superior communication and interpersonal skills.
  • Candidates must have excellent academic achievement and analytical thinking ability.
  • Candidates must have good project management and organizational skills.

PreferredExperience and Skills:

  • Candidates should have a minimum GPA of 3.5.
  • Candidates should have proficiency in Microsoft Office applications.
  • Candidates should have experience writing, editing, and reviewing scientific publications and content.


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 [email protected]

  

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 

          OFCCP EEO Supplement

 Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.
FTP2019 FTPMRL2019

Job: Administrative Svcs Generic
Other Locations: West Point, PA, US; Kenilworth, NJ, US
Employee Status: Temporary
Travel: Yes, 5 % of the Time
Number of Openings: 5
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Company
Merck
Posted
08/17/2018
Type
Full time
Location
Rahway, NJ 07065, US