Principal Scientist, Pharmaceutical Analytical Sciences

Merck•Rahway, NJ

53d•$156,900 - $247,000•Onsite

About The Position

The Pharmaceutical Analytical Sciences team is hiring a Principal Scientist based in Rahway, New Jersey. The role supports analytical methodology development for medicines based on small molecules, peptides, mRNA, oligonucleotides, and bioconjugates, from early development through commercialization. The work spans drug substances and drug product dosage forms, including oral, sterile, and combination products. The Principal Scientist leads analytical teams and makes critical contributions to drug product and process development through analytical characterization, imaging tools, and data analysis. The role includes developing end-to-end analytical control strategies for clinical supplies under good manufacturing practices, supporting regulatory submissions and agency responses, advancing analytical capabilities through novel technologies, mentoring junior scientists, and partnering with internal and external collaborators.

Requirements

PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field and at least 7 years of pharmaceutical industry experience; or a master's degree in one of these fields and at least 10 years of experience; or a bachelor's degree in one of these fields and at least 12 years of experience.
Strong written and oral communication, leadership, teamwork, and interpersonal skills.
Deep technical expertise and strategic experience in analytical control strategy development and execution.
Demonstrated ability to develop talent through mentoring.
Initiative, creativity, and innovation in problem solving.
Ability to design, execute, or direct development and qualification of release, characterization, and stability assays for clinical trial materials and product and process development.
Strong technical problem-solving ability.
Proven external scientific engagement, demonstrated through publications and presentations.
Ability to work independently on analytical methodology development and cross-functionally on successful method transfer, optimization, and documentation to meet program deadlines.
Experience authoring and reviewing technical reports, regulatory filing sections such as IND or BLA sections, and scientific publications.
Experience with matrix management and peer-to-peer coaching.
Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Nice To Haves

Hands-on liquid chromatography (LC) or gas chromatography (GC) method development, analysis, and troubleshooting.
Experience with advanced analytical techniques such as mass spectrometry or dissolution.
Experience developing and characterizing small molecules, large molecules, mRNA, antibody drug conjugates, or their associated drug products.
Established scientific reputation supported by publications and external presentations.
Experience with high-throughput or data-rich experimentation, or data science.

Responsibilities

Lead analytical teams developing drugs in the company pipeline, applying an understanding of product development from early stage through commercialization.
Partner with other functional areas to design scientific studies that guide product and process development.
Define and implement end-to-end analytical control strategies for clinical supplies under good manufacturing practices, including method development, validation, and specification setting.
Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/worldwide marketing application (WMA) submission documents, and respond to agency questions.
Promote scientific excellence and regulatory influence through leadership in the scientific community.
Advance analytical capabilities by adopting and implementing novel technologies for product and process characterization.
Guide teams in designing and executing experiments that inform programs through data-driven decisions.
Mentor and provide day-to-day oversight of junior analytical scientists.
Represent the team or department in presentations to governance committees and internal audiences.
Partner with director-level management to develop and execute scientific and enterprise strategies.
Proactively identify and escalate program risks.
Build trusting relationships through active two-way communication and collaboration with internal stakeholders and external partners.
Apply knowledge of product development and commercialization to analytical development challenges involving small molecules, peptides, mRNA, oligonucleotides, and bioconjugates, using conventional and novel technologies in collaboration with cross-functional teams and external vendors.
Design, execute, or direct development and qualification of release, characterization, and stability assays for clinical trial materials and product and process development.
Develop analytical methodologies independently and work cross-functionally to transfer methods, optimize plans, and document work to meet program deadlines.
Author and review internal technical reports, regulatory filing sections, and external scientific publications.