Attention NJ Applicants: In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
We are seeking a highly motivated and experienced Associate Principal Scientist to join our Cell-Based Sciences team within the Analytical Research and Development organization of our company's Research Laboratories in Kenilworth, New Jersey. The primary role of the successful candidate will be to lead the design, method development, optimization and transfer of cell-based assays for drug substance and drug product release, stability, and characterization that reflect the mechanisms of Action (MoAs) for our Biologics pipeline. As part of this role, they will author and review CMC sections of regulatory submissions and associated source technical reports and risk assessment documents. The ideal candidate should bring expertise in a wide variety of cell methods and technology for assessment of biological potency with an emphasis on subject matter expertise related to Fc effector function activity assessment (ADCC, CDC, ADCP) and/or NK cytotoxicity assays.
The successful candidate should cultivate and foster scientific and technological innovation, leverage external networks to stay current on industry best practices and emerging technologies in potency assay development, champion new initiatives, and seek to enhance functional capability and operational excellence.
Required Experience and Skills:
A Ph.D. with a minimum of 4 years of experience, a Master’s degree with a minimum of 8 years of experience, or a Bachelor’s degree with a minimum of 12 years of experience in immunology, cell biology, bioengineering, biological sciences, or related discipline in the biopharmaceutical industry.
Experience with design and development of robust and reliable cell-based potency assays that reflect the MOA of antibody, ADC and/or other drug modalities.
Proficiency in a variety of biological and immunological techniques such as stable cell line generation, cytotoxicity assays, ELISAs, homogeneous binding assays (AlphaLISA and TR-FRET), flow cytometry, Octet, proliferation, phosphorylation and reporter gene assays.
Hands on experience with development of cell-based assays for characterization of Fc effector functions (i.e. ADCC, CDC ADCP), and NK-cell mediated cytotoxicity assays.
Proficient in common bioassay software and data analysis packages e.g. SoftMax Pro, JMP, PLA software, GraphPad Prism, and Microsoft Office Tools.
Demonstrated ability to deliver complex objectives with ability to work effectively in a collaborative, fast-paced and dynamic cross-functional team environment.
A strong team player with excellent oral and written communication skills; to independently design, execute and troubleshoot experiments; and analyze, interpret, and clearly communicate complex analytical data.
Preferred Experience and Skills:
Background in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DOE) principles as well as data analysis and statistics.
Working knowledge of regulatory and industry guidelines in the area of CMC analytical development.
Track record of scientific publications and accomplishments and active engagement with the external scientific community.
Experience in Cell and gene therapy (e.g. CAR-NK, CAR-T) is a plus.
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., 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.
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.
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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.
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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.
Residents of Colorado:
Click here to request this role’s pay range.
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.
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