Principal Scientist, Analytical Development (Small Molecule)

About the role

Responsible for leading analytical development activities for multiple projects to support drug substance development from preclinical through commercial phase, with a focus on small molecules. Develops, establishes and validates testing methods used to control raw materials, in process testing, intermediates, API. Responsible for development and implementation of control strategies, with special emphasis on advancing innovation in analytical techniques. Responsible for keeping work in compliance with cGMP, safety and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.

Responsibilities

• Plans and manages projects.
• Represents Analytical Development on cross-functional teams.
• Maintains accountability for analytical deliverables and progress on CMC plans for all development projects.
• Independently designs, plans and executes activities towards the goals of one or more analytical chemistry projects to support pre-clinical through commercial activities, as well as contributing to overall control strategy.
• Supervises laboratory work and/or lab personnel and ensures safe laboratory practices.
• Performs analytical development and optimizes methods in support of preclinical through commercialization.
• Creates and implements novel ideas and techniques to support analytical activities with API Development.
• Supports off-site analytical transfers, manufacturing support and interaction with contractors.
• Provides input into CMC regulatory documentation and supporting work.
• Provides effective supervision of laboratory personnel and guidance for their professional development.
• Contributes to development of policies and department strategies.
• Presents findings at varying levels across the company.
• Supports career development and technical growth of direct reports.

Qualifications

• BS/BA in Analytical Chemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field.
• Experience in method transfer in Analytical Chemistry OR
• MS/MA in Analytical Chemistry or related discipline and 10+ years of experience.
• PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience.
• Thorough understanding of analytical chemistry and a well-developed understanding of process chemistry.
• Proficiency in one or more techniques for drug substance characterization, such as LC, GC, IR, MS, NMR, KF, UV etc.
• Excellent interpersonal skills with strong oral and written communication abilities.
• Excellent laboratory and productivity skills.
• Strong technical expertise in method development/validation/transfer experience in Analytical Development.
• Good understanding of cGMP requirements in API and drug product.
• Demonstrated ability working with / recommending a variety of laboratory equipment/tools.
• Ability to work as part of and lead multiple teams.
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.
• Excellent computer skills.
• Excellent communications, problem-solving, analytical thinking skills.
• Sees broader picture, impact on multiple programs, teams and/or departments.
• Able to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management skills.

Skills

• Thorough understanding of analytical chemistry and a well-developed understanding of process chemistry.
• Proficiency in one or more techniques for drug substance characterization, such as LC, GC, IR, MS, NMR, KF, UV etc.
• Excellent interpersonal skills with strong oral and written communication abilities.
• Strong technical expertise in method development/validation/transfer experience in Analytical Development.
• Good understanding of cGMP requirements in API and drug product.
• Demonstrated ability working with / recommending a variety of laboratory equipment/tools.
• Ability to work as part of and lead multiple teams.
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.
• Excellent computer skills.
• Excellent communications, problem-solving, analytical thinking skills.
• Sees broader picture, impact on multiple programs, teams and/or departments.
• Able to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management skills.

Benefits

• Annual base salary range: $130,800.00 - $179,000.00.
• Annual bonus with a target of 30% of the earned base salary.
• Eligibility to participate in our equity based long term incentive program.
• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.