Senior Scientist, Regulatory CMC – Biologics (m/f/d)

We are currently looking for an experienced Senior Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) (m/f/d) to be based in our new office in Zürich. (full-time, indefinite).

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Primary activities include but are not limited to:

• Serve as a Regulatory Chemistry, Manufacturing, and Controls (CMC) Project Lead for early phase programs and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological projects. Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle.
• Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy by robust assessment of global regulatory CMC requirements and identification of potential risks.
• Manage execution of CMC documentation including clinical submissions (IND/IMPD), marketing application (original and supplemental), and/or post approval changes / variations and responses to health authority questions per established business processes and systems.
• Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed
• Conduct all activities with an unwavering focus on compliance

Qualifications:

Education Minimum Requirement:

• B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical or Biological Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry or equivalent experience.
• Several years of Biologics CMC related experience, relevant experience including biological research, manufacturing, testing and/or related field.

Preferred Experience and Skills:

• Experience in Biologics Regulatory CMC is a plus

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.

THE COMPANY

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office will be staffed by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions.

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.

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 for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R127614