Principal Scientist, Pharmaceutical Analytical Sciences Full-time

Principal Scientist, Pharmaceutical Analytical Sciences

The Pharmaceutical Analytical Sciences (PAS) team at our company has an exciting opportunity for a Principal Scientist based in Rahway, NJ. Join us and experience our culture firsthand – one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

As a Principal Scientist, you will be part of a team developing innovative analytical methodologies for medicines based on small molecules, peptides, mRNA, oligonucleotides and bioconjugates. Our responsibilities range from early stage up to commercialization for both drug substance and a broad array of drug product dosage forms, including oral, sterile and combination products. You will lead and make critical contributions to the development of drug product and process through analytical characterization, imaging tools and data analysis. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities, in not particular order and by no means complete, include:

• Leading 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.

Scientific Excellence and Regulatory Influence:

• 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.
• Challenging your teams to design and execute the experiments needed to influence programs with data-driven decisions.

Leadership:

• 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.
• Partnering with director-level management to develop and execute scientific and enterprise strategies.
• 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 deep 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.

Qualifications

Education Minimum Requirements

• PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience.
• Master's Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience.
• Bachelor's Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience.

Required Experience and Skills

• A strong team player with excellent written and oral communication skills, as well as strong leadership and interpersonal skills are necessary to qualify for this role. Additional skills:
• Possess deep technical expertise and strategic experience in analytical control strategy development and execution
• Demonstrated 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
• A proven record of 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. Plan optimization and documentation to meet program deadlines.
• 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
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills

• 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 and and/or their associated drug products
• Established scientific reputation supported by publications and external presentations
• Experience in high-throughput experimentation and data-rich experimentation, or data science

Required Skills:

Analytical Characterization, Analytical Chemistry, Analytical Method Development, Assay Development, Bioanalysis, Chromatographic Techniques, Chromatography, Clinical Judgment, Clinical Trials, Conducting Experiments, Data Science, Liquid Chromatography (LC), Matrix Management, Mentoring Staff, Method Validation, Product Development, Scientific Study Design, Stability Testing

Preferred Skills: