Job Abstract

Job Description

The Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal Scientist position available at our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ingredients (APIs). 

We are looking for a team player with strong leadership skills and the passion for mentoring and working along others in a laboratory setting.  Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior communications skills, both written and oral.  A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience in leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.  An established reputation for scientific excellence supported by publications and external presentations is expected. 

Qualifications
 

Education Minimum Requirements:

• Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 12 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry/biochemistry or related field with a minimum of 16 years of experience in the pharmaceutical industry. 

Required Experience and Skills:

• Extensive experience in analysis of biologics (separation methods such as Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques, and immunoassays such as residual and PCR-based assays).

• Strong background in analytical control strategy development and execution.

• Demonstrated ability to develop talent through good mentoring skills.

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.

• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.

• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.

• A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.

• Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.

• Experience with matrix management and peer to peer coaching

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills:

• Understanding of protein degradation mechanisms and link between analytical methodologies for analysis.

• Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP<1033>.

• Experience with complex glycan analysis and link to mechanisms of actions.

• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).

• Knowledge and experience in Antibody Drug Conjugate method development.

• Established scientific reputation supported by publications and external presentations.

• Strong external network to benchmark competitors and equipment vendors.

• Experience in high-throughput experimentation and data-rich experimentation.

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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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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:

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.

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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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