Rahway, New Jersey, United States · On-site
$142k–$224k/yr
Job Description The Biologics Analytical Research & Development department (BAR&D) is seeking an Associate Principal Scientist position at the Rahway, New Jersey site. This role is a laboratory-based scientific role task…
Skills: Analytical Research and Development, Biochemistry, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques
Rahway, New Jersey, United States · Hybrid
$157k–$247k/yr
Job Description Women’s cancer team at our Company is building a leading portfolio to improve and save lives of women with breast and gyn cancers. The Associate Director Global Marketing Women's Cancers will play a vital…
Skills: Brand Strategy, Business Acumen, Collaboration, Data-Driven Decision Making, Global Strategy
North Wales, Pennsylvania, United States · Remote OK
$157k–$247k/yr
Job Description We are hiring an Associate Director, US Oncology Marketing, for the Skin, GI, and MSI-High CRC portfolio. This is a key leadership role responsible for leading HCP marketing to maximize the impact for pat…
Skills: Brand Management, Budget Management, Business Planning, Customer Segmentation, Marketing Strategies
North Wales, Pennsylvania, United States · Hybrid
$311k–$489k/yr
Job Description The Executive Director (Distinguished Scientist) and Product Development Team (PDT) lead has primary responsibility for the planning and directing of clinical research activities involving new or marketed…
Skills: Clinical Development, Clinical Investigations, Clinical Reporting, Clinical Research, Clinical Trial Planning
Worthington, Minnesota, United States · On-site
Job Description For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the f…
Skills: Electrical System Troubleshooting, Mechanical Troubleshooting, Preventive Maintenance, HVAC Maintenance, Hydraulic Systems
Rahway, New Jersey, United States · Hybrid
$311k–$489k/yr
Job Description The Executive Director (Distinguished Scientist) and Product Development Team (PDT) lead has primary responsibility for the planning and directing of clinical research activities involving new or marketed…
Skills: Clinical Investigations, Clinical Judgment, Clinical Research, Clinical Trial Planning, Consultative Approach
Rahway, New Jersey, United States · Hybrid
$191k–$300k/yr
Job Description We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Director. QP2-IO team is part of the Global Clinic…
Skills: Clinical Pharmacology, Communication, Data Modeling, Data Visualization, Drug Development
United States · Remote OK
$191k–$300k/yr
Job Description Role Summary The US Director, Payor & Access Strategy Lead, Medical Affairs (PASL) is responsible for US Field Medical (FM) strategy, training, and prioritization of the Value & Implementation (V&I) plan …
Skills: Clinical Research, External Collaboration, Managed Care, Medical Affairs, Pharmaceutical Medical Affairs
Rahway, New Jersey, United States · Hybrid
$173k–$273k/yr
Job Description Brief Description of Position The Senior Director, Portfolio & Resource Operations (PROS) reports to the Head of Global Data Management and Standards (GDMS) Business Operations and serves as the lead resp…
Skills: Capacity Planning, Change Management, Clinical Data Management, Data Governance, Good Clinical Practice (GCP)
Rahway, New Jersey, United States · Hybrid
$142k–$224k/yr
Job Description Our Clinical Research and Pharmacovigilance teams advance global healthcare through clinical research and innovation. In support of Global Clinical Trial Operations (GCTO), this role ensures effective exe…
Skills: Change Management, Clinical Project Management, Clinical Trial Management Systems (CTMS), Clinical Trials Operations, Communication
Rahway, New Jersey, United States · Hybrid
$142k–$224k/yr
Job Description Our Clinical Research and Pharmacovigilance teams advance global healthcare through clinical research and innovation. In support of Global Clinical Trial Operations (GCTO), this role ensures effective exe…
Skills: Change Management, Clinical Project Management, Clinical Trial Management Systems (CTMS), Clinical Trials Operations, Communication
Mahwah, New Jersey, United States · Remote OK
$173k–$273k/yr
Job Description At our company, we aspire to be the premier research-intensive biopharmaceutical company. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatme…
Skills: Clinical Research, External Collaboration, Health Outreach, HIV Prevention, HIV Treatment
Petaling Jaya, Selangor, Malaysia · On-site
Job Description Job Overview: This role plays a critical role in ensuring that HR operations are executed with accuracy, consistency, and compliance across AP markets. As an HR Operations Specialist, this role will not o…
Skills: Employee Lifecycle, HR Shared Services, HRIS, Labor Law Compliance, Process Improvement
Boxmeer, North Brabant, Netherlands · On-site
Job Description Ben je gepassioneerd door het continu verbeteren van processen en het behalen van uitstekende resultaten in een internationale farmaceutische omgeving die bijdraagt aan de gezondheid van dieren? Dan ben j…
Skills: Aseptic Operations, Gmp Compliance, Gmp Documentation, Pharmaceutical Manufacturing, Safety Compliance
Cornwall, Connecticut, United States · Remote OK
$173k–$273k/yr
Job Description At our company, we aspire to be the premier research-intensive biopharmaceutical company. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatme…
Skills: Clinical Research, External Collaboration, Health Outreach, HIV Prevention, HIV Treatment
Rahway, New Jersey, United States · Hybrid
$282k–$444k/yr
Job Description The Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a foc…
Skills: Clinical Development, Clinical Medicine, Clinical Research Management, Clinical Studies, Clinical Trial Development
Shanghai, Shanghai, China · On-site
Job Description Study physician Location: Shanghai Our Company seeks individuals to provide leadership and experience in conducting early clinical research in China. One of the most important missions of clinical researc…
Skills: Clinical Research, Clinical Study Design, Regulatory Compliance, Clinical Trial Monitoring, Medical Research
Boston, Massachusetts, United States · Hybrid
$287k–$452k/yr
Job Description Senior Principal Scientist (Senior Medical Director) Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for planning and managing an important …
Skills: Academic Research, Clinical Studies, Clinical Trial Development, Dermatology, Drug Development
Taipei, Taiwan · Hybrid
Job Description Job Title Business Unit Director - Companion Animal (Animal Health) Reports To General Manager – Animal Health THE OPPORTUNITY The Companion Animal Business Unit Director is accountable for end‑to‑end com…
Skills: Business Compliance, Communication Strategy Development, Customer Engagement, Data Analysis, Digital Marketing
Taipei, Taiwan · On-site
Job Description THE OPPORTUNITY As a HR Business Partner, with business objectives and aspiration in the center of everything we do, you partner closely with business leaders at various levels to influence and deliver st…
Skills: Benefits Administration, Career Development, Change Management, Compensation Strategies, Cultural Transformations
Rahway, New Jersey, United States • On-site
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The role involves solving complex analytical challenges to enable the development of biologics drug products through the development and transfer of analytical methods. Responsibilities include leading the design of experiments, data interpretation, and providing technical leadership for monoclonal and complex therapeutic proteins.
Candidates must have a degree in Chemistry, Biochemistry, Engineering, or Pharmaceutical Sciences with experience ranging from 3 to 10+ years depending on the degree level. Required expertise includes hands-on experience in separation sciences, chromatography, and residual impurity assay development.
The Biologics Analytical Research & Development department (BAR&D) is seeking an Associate Principal Scientist position at the Rahway, New Jersey site. This role is a laboratory-based scientific role tasked with solving complex analytical challenges, to enable development of Biologics drug products. The successful candidate must function well in a collaborative, fast-paced, 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 be highly organized, possess excellent oral/written communications skills, display 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 cross-functional collaboration in an academic or industrial setting is also preferred.
Qualifications
Education:
Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field, B.S. with 10+ yrs, MS with 7+ yrs, or Ph.D. with 3+ yrs of relevant experience.
Hands-on experience in separation sciences with chromatography, (e.g. SEC, RP, IEX, HILIC) and/or experience with capillary electrophoresis (CE) analysis (e.g. CE-SDS, iCIEF) for biologics.
Experience with residual impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
Ability to co-design, draft, execute/direct work related to method bridging, comparability, the setting of specifications, etc., from protocol to final report.
Ability to design, execute and/or direct the development of release/stability and characterization methods for clinical trial material and in support of product/process development per ICH Q2 (R2) guidance through method qualification.
Excellent oral and written communication skills; ability to work both independently and cross-functionally.
Authoring and reviewing of SOPs, technical reports, publications and appropriate sections of regulatory filings (e.g., IND, BLA).
Experience with matrix management and peer to peer coaching.
Design of Experiment principles including statistical data analysis using JMP, MiniTab, FusionAE, etc.
Broad knowledge on the panel of biologics assays, charge & size variants, glycans, purity/impurity.
Understanding of protein degradation mechanisms and the link between analytical/orthogonal 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 in representing analytical functional area on project teams.
Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
Experience in data analytics
EligibleforERP
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
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
The salary range for this role is
$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
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.
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.
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.
Travel Requirements:
No Travel Required*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:R404891
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
