Hispanic Alliance for Career Enhancement
Associate Principal Scientist, Chemistry
Hispanic Alliance for Career Enhancement, West Point, Pennsylvania, us, 19486
Job Overview
The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) is hiring an Associate Principal Scientist at its Rahway, NJ and West Point, PA sites. The role involves using innovative analytical characterization technologies to drive late‑stage pharmaceutical drug product development and commercialization, while collaborating across multidisciplinary teams.
Responsibilities
Develop and validate analytical methods, and conduct drug product testing and analytical investigations within a cGMP environment.
Characterize drug products and manufacturing processes, including stability studies and specification development.
Support manufacturing process scale‑up and validation, and prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions.
Respond to regulatory questions and provide analytical support for regulatory interactions.
Collaborate effectively in a dynamic, integrated, multidisciplinary team environment.
Qualifications
Education : PhD in Analytical Chemistry or a related discipline with 4+ years of pharmaceutical development experience, or MS in Analytical Chemistry or a related discipline with 10+ years of relevant experience.
Required Experience & Skills :
Extensive hands‑on experience with UHPLC/HPLC, GC, UV, IR, Karl Fischer titration, and dissolution.
Experience with inhalation product characterization (APSD, DDU, MDU, PSD).
Strong chemistry knowledge and demonstrated problem‑solving ability.
Excellent verbal and written communication, creativity, and strong interpersonal skills.
Team‑orientated with cross‑functional collaboration.
Preferred Experience & Skills :
Hyphenated analytical techniques such as LC/MS and GC/MS with troubleshooting expertise.
Method development and validation experience.
Familiarity with authorship of CMC sections for regulatory submissions.
Compensation Salary range: $142,400.00 – $224,100.00, based on education, experience, location, and business needs. Eligible for annual bonus and long‑term incentive (if applicable).
Benefits Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days. Full details at https://jobs.merck.com/us/en/compensation-and-benefits.
Work Arrangement U.S. Hybrid Work Model (effective September 5, 2023): three on‑site days per week (Mon‑Thu), Friday remote, unless business critical tasks require presence. Positions not eligible for hybrid work include field‑based, facility‑based, and certain manufacturing or research roles.
Legal & Equal Opportunity Merck & Co., Inc. is an Equal Employment Opportunity Employer. Applicants and employees are protected against discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other legally protected characteristic. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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Responsibilities
Develop and validate analytical methods, and conduct drug product testing and analytical investigations within a cGMP environment.
Characterize drug products and manufacturing processes, including stability studies and specification development.
Support manufacturing process scale‑up and validation, and prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions.
Respond to regulatory questions and provide analytical support for regulatory interactions.
Collaborate effectively in a dynamic, integrated, multidisciplinary team environment.
Qualifications
Education : PhD in Analytical Chemistry or a related discipline with 4+ years of pharmaceutical development experience, or MS in Analytical Chemistry or a related discipline with 10+ years of relevant experience.
Required Experience & Skills :
Extensive hands‑on experience with UHPLC/HPLC, GC, UV, IR, Karl Fischer titration, and dissolution.
Experience with inhalation product characterization (APSD, DDU, MDU, PSD).
Strong chemistry knowledge and demonstrated problem‑solving ability.
Excellent verbal and written communication, creativity, and strong interpersonal skills.
Team‑orientated with cross‑functional collaboration.
Preferred Experience & Skills :
Hyphenated analytical techniques such as LC/MS and GC/MS with troubleshooting expertise.
Method development and validation experience.
Familiarity with authorship of CMC sections for regulatory submissions.
Compensation Salary range: $142,400.00 – $224,100.00, based on education, experience, location, and business needs. Eligible for annual bonus and long‑term incentive (if applicable).
Benefits Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days. Full details at https://jobs.merck.com/us/en/compensation-and-benefits.
Work Arrangement U.S. Hybrid Work Model (effective September 5, 2023): three on‑site days per week (Mon‑Thu), Friday remote, unless business critical tasks require presence. Positions not eligible for hybrid work include field‑based, facility‑based, and certain manufacturing or research roles.
Legal & Equal Opportunity Merck & Co., Inc. is an Equal Employment Opportunity Employer. Applicants and employees are protected against discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other legally protected characteristic. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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