Scientist, Engineering ( MERCUSR181703ENUS)
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.
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
As part of Our Company’s Manufacturing Division, within the Large Molecule Science & Technology (LMS&T) group, the Bioprocess Drug Substance Commercialization (BDSC) department provides the technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins) and vaccines. For pipeline programs, BDSC supports various commercialization activities, including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.
Under the general scientific and administrative direction of Associate Director in the Cell Culture Fermentation Sciences (CCFS) group and working in conjunction with internal and external partners, this individual will support late stage and commercial biologics and vaccines program activities within CCFS. The individual will develop and demonstrate scientific, experimental and tech transfer skills focusing on upstream cell culture processing.
Responsible for laboratory-scale and scale-up studies to support commercial process development, process characterization, tech transfer, validation, and investigations.
Design, plan, and execute laboratory experiments to generate high quality data. Perform data analysis and effectively communicate study results to stakeholders.
Author experimental protocols and technical reports, and ensures results are reported clearly and accurately.
Supports process tech transfer to commercial manufacturing sites. Actively interacts with internal and external counterparts, representing functional area on cross-functional teams.
Primary focus will be on upstream cell culture processing, but will develop a working knowledge of the various aspects of product manufacture and functional area interdependencies, including downstream processing, analytical, and site readiness.
Authors required regulatory and technical documentation.
Ensures that process/product are developed and documented according to our Company standard practices.
Education Minimum Requirement:
Bachelor’s Degree in Biological Sciences/Biochemical Engineering/Biomedical Engineering or related field with a minimum of 2 years of relevant experience; or Master’s Degree with a minimum of 1 year of relevant experience.
Required Experience and Skills:
Hands-on experience with mammalian cell culture bench scale and high-throughput bioreactor systems (e.g. 2L, ambr250).
Fundamental understanding of cell culture and bioreactor principles.
Ability to work effectively as part of team and exhibit effective interpersonal skills.
Demonstrates attention to detail, and ability to problem solve and troubleshoot technical and equipment related challenges.
Excellent communication and presentation skills. Good working knowledge of general office software (e.g., Microsoft Word, Powerpoint, Excel, etc)
Preferred Experience and Skills:
Experience with process characterization is preferred.
Experience with continuous cell culture processes is a plus.
Experience with harvest unit operations (e.g. centrifugation, depth filtration) is a plus.
Practical experience in biologics process development, manufacturing batch record reviews and/or operations is a plus.
Working knowledge of statistics (e.g. statistical process control (SPC), multivariate analysis (MVA), Design of Experiments (DoE)) including use of software such as JMP or Design Expert is preferred.
Working understanding of analytical methods to characterize biologics is a plus.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
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.
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.
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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.
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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.
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