Principal Scientist, Pharmaceutical Analytical Sciences
About The Position
The Pharmaceutical Analytical Sciences team is seeking a Principal Scientist based in Rahway, New Jersey. The role develops analytical methodologies for medicines based on small molecules, peptides, mRNA, oligonucleotides, and bioconjugates, supporting development from early stage through commercialization. Work spans drug substances and a range of drug product dosage forms, including oral, sterile, and combination products. The Principal Scientist leads and contributes to drug product and process development through analytical characterization, imaging tools, and data analysis, and contributes to regulatory submissions that enable clinical trials. The position leads analytical teams and partners with cross-functional groups to design studies, establish analytical control strategies for clinical supplies under good manufacturing practices, and develop and validate methods and specifications. It includes authoring regulatory submissions and responding to agency questions; advancing analytical capabilities through novel technologies; guiding data-driven experiments and decisions; mentoring junior scientists; representing teams to governance committees; collaborating with director-level management on scientific and enterprise strategies; and identifying and escalating program risks. The role also builds relationships with internal stakeholders and external partners and applies product development and commercialization expertise to analytical development challenges.
Requirements
- PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field, with at least 7 years of pharmaceutical industry experience; or a Master's degree in one of these fields with at least 10 years; or a Bachelor's degree in one of these fields with at least 12 years.
- Strong written and oral communication, leadership, interpersonal, and teamwork 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.
- Strong technical problem-solving ability.
- Record of external scientific engagement demonstrated through publications and presentations.
- Ability to work independently on analytical methodologies and cross-functionally on method transfer.
- Experience authoring and reviewing technical reports, regulatory filing sections such as IND or BLA, 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 chromatography method development, analysis, and troubleshooting, such as LC or GC.
- Experience with advanced analytical techniques such as mass spectrometry or dissolution.
- Experience developing and characterizing small and/or large molecules, mRNA, and/or antibody drug conjugates and their associated drug products.
- Established scientific reputation supported by publications and external presentations.
- Experience in high-throughput or data-rich experimentation, or data science.
Responsibilities
- Lead analytical teams developing drugs in the company's pipeline, with 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 IND, IMPD, NDA, and worldwide marketing application submission documents throughout the project lifecycle 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 support data-driven program decisions.
- Mentor and provide day-to-day oversight of junior analytical scientists.
- Represent the team or department in presentations to governance committees and other internal audiences.
- Partner with director-level management to develop and execute scientific and enterprise strategies.
- Proactively identify and escalate program risks.
- Build collaborative relationships with internal stakeholders and external partners through active two-way communication.
- Apply knowledge of new 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 on successful method transfer, planning optimization and documentation to meet program deadlines.
- Author and review internal technical reports, regulatory filing sections, and external scientific publications.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and families.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Annual bonus eligibility.
- Long-term incentive eligibility, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
