Analytics Lead Scientist I

Position Summary:

• Work Schedule:  Monday – Friday, 8am-4:30pm 

• 100% on-site

The Analytics Lead Scientist I works with minimum supervision, conferring with superior on unusual matters.  Usually assisted by laboratory technicians/associates.  Demonstrates potential for technical proficiency and scientific creativity through broad assignments.  Has appreciable latitude for unreviewed action or decision.  May be responsible for setting and defining technical objectives and assessing results. Comply with divisional and site Environmental Health and Safety requirements.

The Role:

• Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics.  Sample types include in-process, release or stability.  Techniques include HPLC, GC, Karl Fischer, Disintegration, Friability, Hardness, and appearance. Perform method development, validation, and transfer activities. 

• Independently authors technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures

• Review technical documents for accuracy, thoroughness and regulatory compliance

• Directs work of technical staff regarding work assignments

• Responsible as Technical Lead on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationships to grow the business

• Develop and execute efficiency improvement projects

• Identify and recommend business opportunities on a project specific basis

• Trains, coaches, or mentors others on technical, person development or business issues

• Other duties as assigned

The Candidate:

• Bachelor's degree in related life science or physical science field with a minimum of 11 years related work experience OR Master's degree in related life science or physical science field with a minimum of 9 years related work experience OR Doctorate Degree in related life science or physical science field with a minimum of 5 years related work experience required.

• Hands‑on experience operating HPLC and Karl Fischer (KF) required; experience with GC, ICP-MS and Size exclusion chromatography (SEC) preferred.

• Internal expert on data interpretation, applications, instrumentation and theory in at least one area of expertise

• Based on broad technical skills and drug development experience, anticipates and identifying unmet customer needs

• Propose, evaluate, and assess impact of proposed changes to controlled documents and/or project scope

• Leadership skills are expected as well as excellent written and verbal communication skills with internal and external customers

• Well organized and ability to handle multiple projects as well as efficient time management

• Physical Requirements & Work Environment: Ability to perform duties including standing constantly, walking and sitting frequently, and lifting, pushing, and pulling up to 40 lbs; requires occasional kneeling and frequent reaching. Work is performed in a manufacturing environment with exposure to noise and vibration, constant exposure to potential hazards, and occasional exposure to temperature changes, humidity, wet conditions, and extreme heat or cold.