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Associate Principal Scientist - Biologics Potency



Rahway, NJ, USA
Posted on Sunday, June 9, 2024

Job Description

Position Description:

Associate Principal Scientist – Biologics Potency

We are seeking a highly motivated and experienced Associate Principal Scientist to join our Biologics Potency team within the Cell Based Sciences, Analytical Research and Development organization of our Research & Development Division.

The primary role of the successful candidate will be to lead the design, method development, optimization and transfer of immune- and 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 immunological and cell methods and technology for assessment of biological potency with an emphasis on subject matter expertise related to potency assays for biologicals and new drug modalities.

The qualified candidate will be responsible for program potency strategy, developing, establishing pre-qualification and robustness, and transferring immunoassays and cell-based potency assays to assess the biological activity of various biologics modalities such as antibodies, multifunctional proteins, peptide therapeutics, antibody-drug-conjugates, and novel biologics. In our framework of scientific excellence, the associate principal scientist will be an active individual contributor and guide fellow scientists to the design, execution, and interpretation of potency assays, as well as to the ongoing innovation by proposing, evaluating, and implementing innovative approaches in the field of potency assays.

The successful candidate would have a deep understanding of underlying biological mechanisms and assay principles, with experience in key techniques, such as immunoassay platforms, stable cell line generation and/or cell-based assay development to assess the potency of drug candidates. Experience with multiple techniques and technologies, e.g. flow cytometry or lab automation, will be advantageous. 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.

The candidate will need to communicate results effectively, write technical reports, advise fellow scientists, and participate in cross-functional teams. Experience of working in a GxP regulated laboratory environment for routine sample testing, documentation, and data verification will be a plus. Experience of working with novel biological drug modalities will be a plus.

Position Qualifications:

Education Minimum Requirement:

  • Ph.D. in immunology, cell biology, bioengineering, biological sciences, or related discipline with a minimum of 4 years of experience in the biopharmaceutical industry.

  • OR a Master’s degree with a minimum of 8 years of experience in the biopharmaceutical industry.

  • 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.

Required Experience and Skills:

  • Experience with design and development of robust and reliable immunoassays and cell-based potency assays that reflect the MOA of antibody, ADC and/or other biological drug modalities.

  • Hands on experience with development of immunoassays, cell-based assays and proficiency in a variety of biological and immunological techniques such as stable cell line generation, cytotoxicity assays, ELISAs, flow cytometry, Octet, proliferation, phosphorylation and reporter gene assays.

  • Proficient in common bioassay software and data analysis packages e.g. SoftMax Pro, JMP, PLA software, or 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:

  • Experience with novel biomolecule drug modalities.

  • 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.




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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, 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:

$135,500.00 - $213,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:




VISA Sponsorship:


Travel Requirements:

Flexible Work Arrangements:

Not Applicable


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Hazardous Material(s):

Job Posting End Date:


*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:07/07/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R298018