Merck · 3 hours ago
Associate Principal Scientist, Small Molecule Analytical Research and Development
USA - New Jersey - Rahway
Full-time
Hybrid
Senior Level, Lead/Staff
$142K/yr - $224K/yr
3+ years expMerck is a global healthcare company dedicated to improving human health through innovative drug delivery technologies and predictive analytical tools. They are seeking an Associate Principal Scientist to develop innovative analytical methodologies for small molecules and contribute to regulatory submissions for clinical trials. This role involves leading analytical teams, mentoring junior scientists, and fostering collaborations with internal and external stakeholders.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Leading or participating on analytical teams driving the development of drugs in our Company's pipeline, with a deep understanding of product development from early stage through commercialization
Actively partnering with other functional areas to design scientific studies guiding product and process development
Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices (including method development and validation as well as specification setting)
Authoring investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/ worldwide marketing application (WMA) submission documents across the project development lifecycle, as well as responding to agency questions
Promoting our Company's scientific excellence and regulatory influence through leadership in the scientific community
Advancing and expanding analytical capabilities via the adoption and implementation of novel technologies for product and process characterization
Designing and executing the experiments needed to influence programs with data-driven decisions
Mentoring and providing day-to-day oversight of junior analytical scientists
Representing your team and/or department via presentations to governance committees and other internal audiences
Proactively identifying and escalating program risks
Fostering strong collaborations with internal stakeholders and external partners by actively engaging in two-way communication to build trusting relationships
Applying a strong understanding of new product development and commercialization to analytical development challenges for small molecules, peptides, mRNA, oligonucleotides, and bioconjugates. Use conventional and novel technologies through active collaboration with cross functional project teams and external vendors
Qualification
Required
PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 3 years of pharmaceutical industry experience
Master's Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience
Bachelor's Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience
A strong team player with excellent written and oral communication skills, as well as leadership and interpersonal skills
Possess technical expertise and strategic experience in analytical control strategy development and execution
Ability to develop talent through good mentoring skills
Demonstrated ability for taking initiative, creativity, and innovation in problem solving
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
Strong technical problem-solving ability
External scientific engagement demonstrated by scientific publications and presentations
Ability to work both independently for development of analytical methodologies and cross-functionally for successful transfer methods
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
Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
Preferred
Hands-on chromatography (e.g., LC, GC) method development, analysis and troubleshooting
Other advanced analytical techniques such as mass spectrometry or dissolution
Experience in development and characterization of small and/or large molecules, mRNA, and/or antibody drug conjugates
Established scientific reputation supported by publications and external presentations
Experience in high-throughput experimentation and data-rich experimentation, or data science
Benefits
Medical, dental, vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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