MSD
Job Description
The Biologics Analytical Research & Development department of our company Research Laboratories Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey 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). 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 10 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry, biochemistry or related field with a minimum of 14 years of experience in the pharmaceutical industry. Required Experience and Skills
Extensive experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques) Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques Strong background in analytical control strategy development and execution Demonstrated ability to develop talent through good mentoring skills. Experience with matrix management and peer to peer coaching 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. 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. 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). 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. Required Skills
Analytical Method Development, Assay Development, Bioanalytical Analysis, Business, Chromatographic Techniques, Clinical Judgment, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Innovation, Liquid Chromatography (LC), Management Process, Matrix Management, Mentoring Staff, Method Validation, Personal Initiative, Stability Testing, Technical Writing Preferred Skills
Current Employees apply HERE Current Contingent Workers apply HERE 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, Monday - 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”. Salary Range
$153,800.00 - $242,200.00 Benefits
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. Application
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. EEO Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement, and Learn more about your rights, including under California, Colorado and other US State Acts. Additional Information
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. Search Firm Representatives Please Read Carefully; Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. ...
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The Biologics Analytical Research & Development department of our company Research Laboratories Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey 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). 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 10 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry, biochemistry or related field with a minimum of 14 years of experience in the pharmaceutical industry. Required Experience and Skills
Extensive experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques) Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques Strong background in analytical control strategy development and execution Demonstrated ability to develop talent through good mentoring skills. Experience with matrix management and peer to peer coaching 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. 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. 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). 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. Required Skills
Analytical Method Development, Assay Development, Bioanalytical Analysis, Business, Chromatographic Techniques, Clinical Judgment, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Innovation, Liquid Chromatography (LC), Management Process, Matrix Management, Mentoring Staff, Method Validation, Personal Initiative, Stability Testing, Technical Writing Preferred Skills
Current Employees apply HERE Current Contingent Workers apply HERE 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, Monday - 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”. Salary Range
$153,800.00 - $242,200.00 Benefits
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. Application
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. EEO Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement, and Learn more about your rights, including under California, Colorado and other US State Acts. Additional Information
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. Search Firm Representatives Please Read Carefully; Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. ...
#J-18808-Ljbffr