Sr. Scientist, Analytical R&D

** Job Description
**** Sr. Scientist, Small Molecule Analytical Research & Development
** The Small Molecule Analytical Research and Development group has an opening for a Senior Scientist based in Rahway, NJ. Join us and experience our culture first-hand - 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  your role as Senior Scientist, you will be part of a team developing innovative analytical methodologies for early to late phase programs with application to drug substance and a broad array of drug product dosage forms, combination products and modalities through analytical characterization, imaging tools, and data analysis.

You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities include:
* Driving solutions to analytical development challenges for synthetic small molecule, peptide and oligonucleotide active pharmaceutical ingredients and pharmaceutical products using conventional and novel technologies
* Designing scientific studies to inform the selection and deep understanding of synthetic routes, formulation compositions, and manufacturing processes.
* Implementing analytical methods for laboratory development, as well as release and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) conditions.
* Providing leadership not only on drug development pipeline projects, but also innovative technology teams shaping analytical methods and tools of the future.
* Authoring regulatory submission documents across the project development lifecycle, as well as responding to agency questions.
* Documenting work in a detailed and timely manner.
* Collaborating effectively with internal and external partners.
* Presenting results of experiments and innovation efforts to project teams and at various cross-functional forums.
* Engaging in the external scientific community, e.g. through participation in professional organizations, conferences, and publications.
* Travel Requirements: 5% Travel
** Education

Minimum Requirements:

** Applicants must hold one of:
* PhD in Chemistry, Pharmaceutical Science, or related discipline
* Master’s degree in chemistry, Pharmaceutical Sciences, or related discipline plus at least 3 years of pharmaceutical industry experience.
* Bachelor’s degree in chemistry, Pharmaceutical Sciences or related discipline, plus at least 7 years of industry experience.
** Required Experience and Skills
*** A proven record of strong technical problem solving and innovative research experience, supported by scientific publications.
* Excellent written and oral communication skills.
* Strong leadership, collaboration and interpersonal skills.
** Preferred Experience and Skills
** While not required, experience in one or more of the following areas is preferred:
* Experience with large molecule characterization (oligonucleotides, enzymes, peptides, etc.)
* Chromatography (e.g. LC, GC) method development, analysis and troubleshooting.
* Other advanced analytical techniques such as mass spectrometry or dissolution.
* Data science#AR&D
*
* Required Skills:

** Accountability, Adaptability, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biochemical Assays, Cell-Based Assays, Chromatographic Techniques, Communication, GMP Environments, Innovative Thinking, Nuclear Magnetic Resonance (NMR) Analysis, Process Analytical Technology (PAT), Strategic Thinking, Team Management, Technical Writing, Ultra Performance Liquid Chromatography (UPLC)
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we…