Job Description
Position Description:
- As part of Microbiology Quality and Sterility Assurance (MQSA) department (~20 persons located in EU/US), your virology expertise and analytical capabilities will be utilized to support in-line non-sterile, biologics and vaccines products.
- You interact internally with product teams and externally with several global contract manufacturing organizations in EU, US and Asia to select, qualify and implement the appropriate adventitious viral agents detection methods and harmonize the viral control strategies, the viral inactivation and viral safety aspects of our processes.
- You create awareness to the shop floor for viral safety and risks associated with our processes and its manipulations.
- You fulfil a role as internal consultant within our Company using your in-depth understanding of contamination control, viral risks and the viral clearance concepts in vaccines and biotech manufacturing process. Provide responses to queries (RTQs) and inspection support (e.g. FDA, EMA, China) including responses to agency follow up questions.
- You network with your peers in MQSA, Analytical Science groups and our Research Laboratories to assure end-to-end suitability of our strategies and to learn and develop in the field of pharmaceutical virology.
Position Qualifications:
Education Minimum Requirement:
Bachelor’s Degree in Molecular Life sciences, Biotechnology, Molecular biology or Biology, with multiple years of experience in the field of virology, biotechnology and/or Life Sciences.
Required Experience and Skills:
- Experienced virology specialist who can complement the enthusiastic team
- Service-orientated and supportive attitude, while independent and confident of your expert opinion
- Attention to detail and the ability to maintain an overview of your work
- Knowledgeable about the regulations on viral safety and industry expectations
- Collaborative team player, that is adaptable and flexible, and maintains a pro-active attitude
- Full command of the English language (in writing and speaking)
- Excellent communication and documentation skills
- Willingness to travel
Preferred Experience and Skills:
- Viral risk as part of Contamination control (facility)
- Viral risk as part of the production process (end-to-end)
- Viral clearance studies, disinfection efficacy, and viral inactivation methods. (filtration/chemical/low pH treatment)
- Experience with viral- and adventitious agents detection methods
- Experience in Chemical, Manufacturing and Control (CMC)
Who we are …
We are known as Merck & Co., Inc., Rahway, 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.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R238556