Principal Scientist, mRNA Vaccine Development

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Applications are sought for a scientific opportunity in our Company's Vaccine Process Research and Development division. Under the direction of the director, individual will support process development of mRNA based vaccine candidates.

The successful candidate will perform lab-scale process development/scale-up studies, develop robust, efficient, scalable processes for mRNA vaccine production, participate in the manufacture of cGMP clinical bulks, and transfer processes to clinical or commercial manufacturing facilities. Duties may include: in vitro transcription and capping reactions, mRNA purification, in-process assay support, process scale-up and engineering, cGMP document preparation and modifications, maintaining/coordinating raw material, and equipment inventories, technology transfer to manufacturing, and functioning as a lead of a process development team.

Primary responsibilities include, but are not limited to:

• Support the process development, characterization, and technology transfer for mRNA based vaccine products.

• Contribute to the development of new principles, concepts, and methods to enable process development, scale-up of processes to pilot scale, and technology transfer to manufacturing scale. Develop robust and scalable manufacturing processes while minimizing time to file and launch.

• Represent functional area in cross functional and strategic teams engaged in novel vaccine development. Actively interacts with internal and external counterparts.

• Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to our company's standard practices.

• Provides mentorship, technical oversight and strategic guidance to employees. Potentially manages a small group of individual contributors

• Handle multiple priorities and balance work to achieve business goals. Support/lead strategic initiatives.

The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also expected to demonstrated flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training, and maintain a focused attention on laboratory safety for him/herself and his/her team.

Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Travel may be required to support technology transfer. This position will require occasional off hour and weekend work.

Education Minimum Requirement:

• Must have a BS or MS or PhD in engineering or biological sciences

Required Experience and Skills:

• For BS, at least twelve (12) years of experience in biotechnology related position

• For MS, at least ten (10) years of experience in biotechnology related position

• For PhD, at least eight (8) years of experience in biotechnology related position

• Must have strong scientific understanding of mRNA production and experience with practical hands-on process development experience

• Excellent scientific understanding of IVT and capping reaction as well as mRNA purification

• At least 4 years of hands-on experience in mRNA production processes

• Prior experience of statistical design of experiments

• Experience in mentoring/managing others

• Strong understanding of or experience in cGMP manufacturing.

Preferred Experience and Skills:

• Prior experience in process scale up is strongly preferred

• Prior experience with plasmid production

• Experience in authoring and reviewing CMC regulatory documentation

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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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:

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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., 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R174266