DIRECTOR, ANALYTICAL SCIENCES & R&D

Job Description

RESPONSIBILITIES:

Manage the analytical sciences group and the method development sub-group to develop/troubleshoot methods for all type of finished dosage forms.

Address all analytical issues in FDA deficiency letters and develop solutions and write responses.

Write/review method validation/development protocols/reports.

Conduct research/ investigation into analytical testing result failures.

Comply with cGMP regulations and follow all standard operating procedures.

Cooperate with other departments to obtain items needed for analytical work.

Review quality/technical activities to ensure SOP/GMPs followed.

Perform and/or assist with equipment calibrations and qualification.

Train and guide chemists with method development as needed.

Other related duties as required.

QUALIFICATIONS:

MS or Ph.D. in organic chemistry, analytical chemistry, pharmaceutical Sciences, or related scientific discipline required.

10+ years’ experience in a pharmaceutical ANDA & NDA development/analytical/CDMO lab.

8 + years’ experience with analytical instrumentation, such as HPLC/ GC/MS/ICP and other analytical instrumentation.

Experience managing analytical group; Leadership and people management skills.

Experience in an FDA regulated environment as well as familiarity with issues of compliance for State and Federal regulations.

Extensive HPLC experience, method development and validation.

Proficient with MS Office programs and project management.

Strong communication skills, both written and verbal.

Ability to lead, organize, prioritize, and effectively perform concurrent tasks.

Strong attention to detail and desire and ability to work in a positive team environment.

Full-time