Job Description
Job Description Job Function: - This position is a scientific role in a fast-paced, multidisciplinary team environment.
- The successful candidate will be joining a group of innovative analytical scientists with broad deliverables to support commercial pharmaceutical products ensuring undisrupted supply of our Company products to patients globally.
- The incumbent is expected to interact closely with internal sites and external partners in our Company network in identifying issues/gaps and implementing solutions, providing strong analytical support such as troubleshooting laboratory test methods and workflows as well as material for ensuring compliant, robust, and responsive supply.
- The individual will have a deep understanding of the global regulatory and business environment and the needs related to pharmaceutical drug substance and drug product development, GMP compliance in commercial manufacturing and data integrity.
Education Minimum Requirement: --
- Bachelor's Degree in Chemistry or related discipline with at least ten (10) years of relevant pharmaceutical development experience, OR
- Master's Degree in Chemistry or related discipline with at least eight (8) years of relevant experience, OR
- PhD in Analytical Chemistry or related discipline with at least four (4) years of relevant experience
Required Experience and Skills: - Strong analytical chemistry knowledge and extensive experience in analytical development
- Demonstrated problem solving ability including the ability to perform investigations with strong technical troubleshooting skills
- Experience with common analytical techniques such as chromatography, spectroscopy, dissolution and Karl Fischer
- Strong communication (verbal and written) and interpersonal skills, demonstrated ability to work in an interdisciplinary team environment
- Ability to quickly adapt to changes and develop appropriate plans for managing risks
- Working knowledge of GMP and data integrity and recent industry trends in commercial production space
- Experience working with CMO's and CRO's
Preferred Experience and Skills: - Working knowledge of pharmaceutical drug substance and/or drug product development and commercialization
- Working knowledge of CMC filing requirements and regulatory guidances (e.g., ICH) for drug substance and/or drug product
- Experience supporting regulatory inspections and internal audits as analytical subject matter expert
- Experience assisting in developing/implementing CAPA's-
- Strong interpersonal skills including embracing of diversity and inclusion, and working cross-culturally
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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•
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
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".
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 candidate's relevant skills, experience, and education.
Expected US salary range:
$139,600.00 - $219,700.00
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 .
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, 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.-
Employee Status: Regular
Relocation: Domestic
VISA Sponsorship: No
Travel Requirements: 25%
Flexible Work Arrangements: Hybrid
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): n/a
Required Skills: Adaptability, Adaptability, Analytical Chemistry, Analytical Development, Biochemical Analysis, Business, Chemical Synthesis, Clinical Judgment, Communication, Computational Chemistry, Corporate Productions, Cross-Cultural Awareness, Data Analysis, Data Integrity, Enzymology, Experimental Development, GMP Compliance, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Lead Optimization, Liquid Chromatography-Mass Spectrometry (LC-MS), Molecular Structure, Pharmaceutical Development, Pharmaceutical Guidelines, Polymerase Chain Reaction (PCR) {+ 5 more}
-Preferred Skills: Job Posting End Date: 06/7/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R351080
Job Tags
Holiday work, Full time, For contractors, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,