Our Development team ensure production can be scaled up whilst remaining stable, effective, deliverable and safe. Following formulation, cutting edge computer modelling techniques are used to simulate outcomes and, if successful, PKPD and toxicity studies bring the science one step closer to giving hope to patients.
Our Scientists are our Inventors. We deliver robust scientific data and interpretation that drives the commercialization of breakthrough therapeutics using innovative thinking, state-of-the-art facilities and modern equipment. 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 your career.
The Analytical Research and Development, Cell Based Sciences team in Kenilworth, NJ is seeking a motivated scientist with technical expertise in Biologics Potency assays. More specifically, the ideal candidate will be a recognized expert developing mechanism-of-action reflective potency assays for development of therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or new modality-based products.
The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. They will be accountable to inspire and sponsor scientific evaluation and implementation of innovative and disruptive technologies and approaches. Responsibilities include representing the group on product development teams and defining the potency strategy for a portion of our large molecule portfolio, oversight of method development and testing, and scientific mentoring. The candidate will be expected to effectively communicate with stakeholders in partner organization and to management and governance teams.
Education Minimum Requirement:
Ph.D. in analytical chemistry, molecular biology, cell biology, or related field with a minimum of 8 years of industry experience in the Biopharmaceutical Industry.
OR M.S. with a minimum of 10 years of experience in the Biopharmaceutical Industry.
OR Bachelors with a minimum of 14 years of experience in the Biopharmaceutical Industry.
Required Experience and Skills:
Expertise in cell biology and immunology, with application to solve complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities, preferably with experience in Antibody-Drug Conjugates and/or other new modality-based therapy development.
Expertise in a variety of functional potency assay technologies, such as cell line engineering to build reporter gene assays, flow cytometry, natural killer (NK) cell assays for cytotoxicity, and/or effector function assays. Strong understanding of binding assays such as immunoassay and surface plasmon resonance is a plus.
Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development.
Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities.
External scientific engagement that may include a combination of publications, industry white paper contributions, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.
Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.
Excellent verbal and written communications skills.
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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For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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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.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range: $129,800.00 - $220,500.00 For Washington State Jobs, a summary of benefits is listed here .
Learn more about your rights, including under California, Colorado and other US State Acts
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: Regular
VISA Sponsorship: Yes
Flexible Work Arrangements: Not Specified
Shift: Not Indicated
Valid Driving License:
Hazardous Material(s): OEB4, OEB5 compounds
Number of Openings: 1
To apply please click on APPLY TO THIS POSITION
Job Post Date: 01/06/23
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