Associate Principal Scientist, Analytical R&D
Associate Principal Scientist, Analytical R&D
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$ 139600 - 219700
1 Vacancy
Job Description
Job Description
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking stateoftheart facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.
The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway New Jersey research facility. The Associate Principal Scientist is a laboratorybased scientific role tasked with solving complex analytical problems at the interface of biology chemistry and lab informatics disciplines to enable development of Biologics drug substances and drug products. The successful candidate must function well and be able to collaborate in a fastpaced integrated multidisciplinary team environment. The qualified candidate will be responsible for development qualification implementation troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins. Responsibilities include development of new assay platforms benchmarking current approaches/techniques to industry standards and providing technical leadership of design of experiments and data interpretation. Applicants must have effective organizational multitasking oral/written communications skills show scientific leadership and a desire to conduct research and publish. Experience leading small groups of technical personnel and analytical projects will aid in distinguishing candidates. Evidence of strong crossfunctional collaboration in an academic or industrial setting is also preferred.
Qualifications
Education:
B.S. in Chemistry Biochemistry Engineering Pharmaceutical Sciences or related field with 10 years of relevant experience; or Masters degree with 7 years of relevant experience; or Ph.D. with 3 years of relevant experience.
Required Experience and Skills:
Strong background and experience in separations science
Extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC RP IEX) and/or experience with capillary electrophoresis (CE) analysis of biologics (e.g. CESDS iCIEF)
Extensive experience with process and impurityrelated residual assay development using molecular biology and immunoassay techniques.
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.
Accurately and efficiently documentation of experiments
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 in representing analytical functional area on project teams.
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)
Experience in data analytics programming or laboratory automation.
#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:
$139600.00 $219700.00Available 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):
Required Skills:
Adaptability Adaptability Analytical Method Development Animal Vaccination Antibody Drug Conjugates (ADC) Antibody Therapeutics Applied Engineering Assay Assay Development Biochemical Analysis Biochemistry Biological Assay Development Capillary Electrophoresis (CE) CellBased Assays Chromatographic Techniques Clinical Testing Communication CrossFunctional Teamwork Drug Development External Collaboration Gel Electrophoresis High Resolution Mass Spectrometry (HRMS) Immunoassays Immunochemistry Immunoprecipitation 17 morePreferred Skills:
Job Posting End Date:
06/4/2025*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
