The Senior Research Scientist I is a scientific leader in the AD laboratory, able to independently conduct a broad range of routine analyses, develop and validate methods and document results in notebooks. As assigned, the Senior Research Scientist prepares, reviews and/or approves protocols, reports and investigations. The Senior Research Scientist mentors other analysts in the execution of laboratory projects, conducts training and communicates well within or outside of group boundaries.Description of KEY responsibilities:
Lead groups of junior scientists in laboratory projects, or in the development of SOPs or systems
Conduct or oversee the development of robust and transferrable analytical methods for ANDA candidates
Conduct or oversee routine sample testing, such as dissolution, assay stability, etc.
Prepare and/or review notebook records, analytical methods, specifications and reports.
Lead or participate in laboratory investigations to determine root cause and write an investigation report
Perform method validation for methods such as cleaning, assay, dissolution, related compounds or particle size, as assigned.
Prepare, review or authorize method validation reports for ANDA filing
Design specifications and other key project documents.
Experience and education required
PhD + 8 or Masters + 12 or Bachelor's + 20 years' experienceSkills and specific knowledge required
Strong background and extensive experience in Analytical Chemistry with emphasis on routine testing, method development and validation, preferably in a regulated industry.
Strong practical knowledge of chromatography (HPLC, GC, TLC), spectroscopy (UV, FTIR) and related techniques.
Proficient in troubleshooting and planning of laboratory tasks. Able to work independently, and to guide the work of other scientists, with or without a reporting relationship.
Strong communication and technical writing skills.
Work Environment and Physical Demands
Able to work productively and safely in a laboratory environment
Lifting up to 20 lbs.
Able to use personal protection equipment as required
Core competencies identified
Designs methods and SOPs that others can easily follow
Leads small groups on scientific or compliance tasks
Follows written and verbal instructions well
Organizes time to accomplish complex tasks
Plans well to avoid errors during testing
Writes notebook records clearly and reliably
Understands and applies GMP principles
Applies good scientific thinking
Makes decisions responsibly
Please refer to "Qualfications"