Senior Manager, Analytical Chemistry


Senior Manager, Analytical Chemistry
SSF, CA
Responsibilities:
  • Setting up lab (not yet started), acquiring necessary equipment and working with Quality to ensure that equipment has been properly qualified before being put into use.
  • Developing HPLC methods to test sustained release drug product. Ensure that we have correct equipment to measure drug concentrations at levels being eluted.
  • Working with third-party vendor on HPLC-MS methods for bioanalytical activities.
  • Collaborate with consulting Process Chemist on methods for ensuring API is in correct crystalline structure and appropriately characterized.
  • Design experiments, write protocols, conduct data analysis, and write final reports for eventual FDA submission.
  • Present data to team in regular project reviews.
  • Help run experiments in lab; however, we intend to also hire a chemistry technician. This chemist would manage the technician.
  • Other activities based on skill set and background.
Prior experience / skills:
  • Strong preference for analytical chemist with experience working on sustained release drug products that have been reviewed by FDA.
  • Strong collaboration skills since organization is currently working virtually due to shelter-in-place.
  • Writing sample will be required as part of interview process, so strong written English skills are essential.
  • Experience managing a chemistry technician.
  • If chemist also has some formulation experience, that is helpful.
  • Bachelor's degree required; Master's or PhD preferred.

Job Details

Job Type: Contract to Hire
Location: Brisbane, CA
Job ID: 20-05416
Date Updated: August 7, 2020