Principal Scientist, Analytical R&D Biologics
Principal Scientist, Analytical R&D Biologics
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$ 153800 - 242200
1 Vacancy
Job Description
Job Description
The Biologics Analytical Research & Development department of our companys Research Laboratories Division is seeking applicants for a Principal Scientist position available at our companys 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 multitasking 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 crossfunctional collaboration is expected. Experience in leading small groups of technical personnel leading projects and defining group or departmental strategy will aid in distinguishing 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 PCRbased 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 crossfunctionally 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 antibodydrug 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 highthroughput experimentation and datarich experimentation.
AR&D
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 candidates relevant skills experience and education.
Expected US salary range:
$153800.00 $242200.00Available 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.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
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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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
06/30/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Staff IC
Employment Type
Full-Time
