Sr. Manager, INH Analytical R&D
DUTIES & ESSENTIAL JOB FUNCTIONS
REPORTING RELATIONSHIPS - 0 to 10 (or more) direct reports, including other managers.
Will support formulation development work by developing, troubleshooting, and validating suitable analytical (LC, GC) test methods quickly and efficiently. Examples include assay and related subs methods for actives, fast LC methods for DDU and APSD, and GC and LC methods for excipients. Will perform hands-on lab work as well as direct, develop and train analytical scientists. Will provide routine characterization of R&D formulations and analytical support for studies necessary for chemistry, manufacturing and controls (CMC). In addition, will transfer methods to the quality control (QC) laboratory.
OTHER FUNCTIONS AND RESPONSIBILITIES
Troubleshoot equipment problems and work with instrument manufacturer and third party service providers to resolve issues. Coordinate equipment qualification and calibration. During product transfer, work closely with QC for method transfers, ensuring smooth transfers. During pre-approval inspection audits, provide required scientific help justifying test methods, as required.
- BS with 15+ years of experience (pharmaceuticals or related) or MS or PhD in Analytical Chemistry with 10+ years of experience (pharmaceuticals or related)
- Expert in test method development, troubleshooting, and validation
- Experience with HPLC, GC, and other relevant analytical instrumentation
- Strong technical writing skills
- Must be able to perform laboratories duties that require standing for up to 90% of the work day, lifting containers containing up to 4+L of liquids and fine motor skills for conducting laboratory experiments (including weighing and pipetting).
- Supervisory experience of analytical R&D teams
- Experience with MDI product testing
- Experience developing generic products, including inhalation products
- Familiarity with cGMP regulations, FDA guidance documents, and QbD
- Able to wear a respirator