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Job Details


Merck & Co, Inc

2022 Chemistry, Manufacturing & Controls Regulatory Intern ( MERCUSR145921ENUS)

Manufacturing and Production

Manufacturing Engineer

Yearly

No

North Wales, Pennsylvania, United States

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021 or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research Division can provide you with great development and a chance to see if we are the right company for your long-term goals.

Our Company 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 our Company has codified its legacy for over a century. Our Company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Our Company 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. Our Research Division is a true scientific research facility of tomorrow and will take our Company'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.

Our Research Division is recruiting summer interns within the Global Regulatory Chemistry, Manufacturing, and Controls (CMC) group. Five internship positions are available in 2022 in the CMC group with locations in Lansdale, PA, Rahway, NJ and Kenilworth, NJ. Our group strives to improve public health by enabling access to our Company's 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, drug- and biologic-device combination products and vaccines. In addition, students interested in enabling regulatory data acquisition and process efficiency through automation can apply.

This opportunity will expose the intern to various areas of the department and provide beneficial experience and understanding of regulatory CMC principles, strategies and 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 GMPs.

  • Perform regulatory intelligence investigations on global CMC regulatory requirements

  • Understand manufacturing changes to ensure compliance with appropriate change control systems/process and determine regulatory filing strategy (PAS, CBE, Annual Reports, etc.)

  • Gaining speed and accuracy in regulatory CMC work through automation.

The internship positions are full-time. Housing subsidy is not available as part of this program and must be funded 100% by the student.

Required Education and Experience:

  • Candidates must be currently pursuing a minimum of a bachelor's degree in regulatory science, pharmaceutical science, pharmacy, chemistry, biomedical or other engineering disciplines, or other related fields in science and technology.

  • Candidates must have completed at least (2) years of study undergraduate/ (1) year of study graduate by June 2022.

  • Candidates must be available to work full-time for up to (12) consecutive weeks beginning in May or June 2022.

  • Candidates must have superior communication and interpersonal skills.

  • Candidates must have excellent academic achievement and analytical thinking ability.

  • Candidates must have good organizational skills.

Preferred Experience and Skills:

  • Candidates should have a GPA of 3.5 or higher.

  • Candidates should have proficiency in Microsoft Office applications.

  • Candidates should have experience writing, editing, and reviewing scientific publications and content.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

FTP2022MRL2022

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Intern/Co-op (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

5

Requisition ID:R145921