Director/SR Manager, Analytical Sciences R&D

We currently have an open position for a Director/Sr Manager, Analytical Sciences R&D in the Irvine, CA location.

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.
• 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.

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

Job Type: Experience

Schedule: Full-Time

At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer.

All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.