Scientist Jobs

About The Position

Requirements

• PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field, with a minimum of 7 years of experience in pharmaceutical development; experience specifically in analytical development is highly preferred, ideally with experience in various dosage forms.
• M.S. in a related field with a minimum of 12 years of experience in the pharmaceutical industry, or B.S. in a related field with a minimum of 16 years of experience in the pharmaceutical industry.
• Strong expertise in chromatographic (HPLC/UPLC) and spectroscopic (UV/VIS) method development, and recognized expertise in dissolution, particularly with USP Apparatus II (Paddles) and IV (Flow Cell).
• Extensive knowledge of current quality and regulatory requirements for new drug products.
• Demonstrated track record of interacting with regulatory agencies (e.g., FDA/CVM, EMA) on analytical topics.

Nice To Haves

• Significant experience with dissolution development and preparing regulatory submissions.
• Experience working in regulated environments (e.g., GMP).
• Proven scientific leadership skills.
• Strong collaborator with the ability to positively impact interdisciplinary and international teams.
• Strong problem-solving skills, including strategic and creative thinking.
• Experience in analytical method development in areas outside of dissolution.

Responsibilities

• Develop and deliver relevant analytical and dissolution methods and specifications, ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH).
• Interpret results, evaluate data, and draw relevant conclusions.
• Report and present scientific/technical results internally, create external publications, and present at scientific conferences.
• Write or support the generation of international registration documents and interact with global health authorities.
• Partner with manufacturing and regulatory representatives to drive drug product commercialization activities and technical submissions to global health authorities.
• Drive the evaluation and implementation of new technologies in dissolution and analytical development, applying the latest scientific thinking to help bring new drug products to market.
• Mentor and coach emerging technical talent within the function.
• Ensure compliance with external and internal guidelines/quality standards (e.g., SOPs, GxP, HSE, and Animal Welfare).

Benefits

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching