Principal Scientist

Overview:
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.

**Responsibilities**:

- 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 Qualifications:

- 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