Director, Analytical Development & Stability - Chandler, AZ | Biospace
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Director, Analytical Development & Stability

Insys Therapeutics

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Location:
Chandler, AZ
Posted Date:
8/1/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Development, Director, Quality, Validation,

Job Description


PURPOSE:

The Director, Analytical Development & Stability leads a group that provides analytical development and validation for new pharmaceutical products. This position is responsible for planning, prioritizing, and overseeing other individuals who manage analytical testing. He/she ensures appropriate interactions with the FDA, and internal and external teams performing analytical studies. This Director also advises the team regarding scientific questions arising on a day-to-day basis and contributes to the writing of study reports and FDA submission documents.

RELATIONSHIPS:

The Director, Analytical Development and Stability has direct supervisory responsibility for the Analytical team, and works closely with QC/QA, Regulatory Affairs, Research & Development, Manufacturing and CMO. Other relationships include manufacturing partners, third-party vendors, associations, and home office personnel.

ESSENTIAL FUNCTIONS:

•   Responsible for analytical method development and validation for new products
•   Schedule and supervise laboratory activities
•   Troubleshoot and resolve technical issues
•   Responsible for new product stability testing program
•   Responsible for development of CMC sections for assigned new products for FDA submission
•   Assist in responding to FDA queries related to new product submissions
•   Responsible for GMP compliance of the lab operation
•   Supervise and train Analytical Scientists
•   Maintain audit readiness of the lab for inspections by regulatory agencies
•   Help maintain departmental budget
•   Some overnight travel (10%) is expected

Requirements


EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

•   PhD in Chemistry or related field with minimum of 10 years of industry-related experience, or, BS/MS with 15 years of industry related experience
•   At least 5 years' supervisory experience managing projects and personnel
•   Background in testing of inhalation products desired
•   In-depth knowledge and training on project management and analytical study activities
•   Strong familiarity with ICH, GMP guidelines and SOPs
•   Strong oral and written communication skills
•   Excellent organizational and planning skills
•   Strong interpersonal skills and demonstrated ability to work in project team environment
•   Excellent judgment and decision making skills
•   Clear evidence of leadership

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management’s assignment of essential functions. It does not prescribe or restrict the tasks that may be assigned.