The Principal Scientist will provide technical expertise in developing and
evaluation innovative solutions for advancement of extractable/leachables and other
testing related to service offerings of the analytical chemistry department. The position
is responsible for making recommendations to management, executing or leading studies
in support of R&D process development and scientific advancement.

• Responsible for being the technical expert by collaborating with groups,
departments, clients, vendors and a resource for technical development projects.
• Anticipate potential problems and design preventative, innovative solutions.
• Be proactive in developing improvements and introducing them into to regular
production.
• Keep a high level of scientific excellence by regularly participating in scientific
events and meetings related to core scientific strengths of the department.
• Perform regular literature searches and maintain a high awareness of regulatory
changes/challenges.
• Publish in peer reviewed journals whenever possible.
• Evaluate and make recommendations for purchase of various analytical
equipment.
• Research new analytical techniques and test methods, and work with staff to
estimate material and labor costs
• Able to evaluate available analytical techniques and determine the optimal choice
for a proposed project
• Use knowledge of industry standards including FDA and ICH guidance to provide
strategic direction and technical support to staff and clients
• Ensure customer satisfaction, manage client expectations, provide professional
support at all times, and respond promptly to client inquiries
• Track and monitor regulatory feedback and provide updates and direction to
technical support team
• Responsible for mentoring and providing guidance for less senior personnel.
• Assume a leadership role in solving difficult problems associated with specific
projects

• Minimum of 10 years of relevant experience or equivalent
• PhD in Life Sciences or other medical related field or equivalent experience

Knowledge / Skills / Abilities:
• Knowledge and competency in a wide range of analytical techniques
• Experience in collaboration across multiple groups within and outside the
department
• Good planning, resource management and project management skills
• Demonstrated success in developing new technology/methodology
• Fully proficient in functional/technical problem solving time management and
proven organization and interpersonal skills
• Strong problem solving abilities, creativity and efficient time management
• Proficient in Oral & Written communication skills
• Leadership, coaching and mentoring skills needed to facilitate knowledge sharing
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

An Equal Opportunity Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual orientation, gender identity,
national origin, or protected veteran status and will not be discriminated against on the
basis of disability