Scientist, Analytical Development

Location
South San Francisco, California
Posted
Jul 06, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

The Analytical Development Scientist will be responsible for developing and utilizing wet chemistry, chromatographic, spectroscopic and analytical characterization techniques to enable small molecule drug substance (DS) and drug product (DP) development from pre-clinical to commercial filing. The primary responsibilities include analytical method development/optimization, method transfers/validations, structure elucidation of unknown impurities and degradants, analytical investigations/troubleshooting, process and product characterization supporting the development and commercialization of Portola’s small molecule synthetic DS processes and DP formulations. Responsibilities will also include reviewing data, protocol and reports related to method validation and release and stability testing of small molecule DS and DP. The successful candidate should be familiar with USP/NF analytical procedures and have a thorough understanding of cGMP’s and ICH guidelines. The successful candidate will thrive in a team environment with members of cross-functional organizations including medicinal chemistry, process chemistry, formulation development, quality assurance, regulatory, manufacturing, and external CMOs.

 Responsibilities:

  • Responsible for method development/qualification/transfer/troubleshooting to external Contract Testing Labs and Manufacturers
  • Support analysis of API and drug product using state of the art analytical techniques such as HPLC, LC-MS, Dissolution, UV-Vis and KF
  • Responsible for hands-on and technical support to internal and external partner organizations including process chemistry, formulation development, manufacturing, quality control, and quality assurance
  • •Provide technical support for OOS/OOT deviation investigations and troubleshoot analytical or manufacturing issues in a timely manner
  • Plan and organize internal and external analytical experiments to meet specific technical objectives
  • Prepare and/or review written technical reports, procedures, and product/process investigations
  • Use good scientific judgment in all activities
  • Participate in cross-functional meetings to establish priorities and organize activities and communicate scientific results

Qualifications:

  • A BS/MS degree in the field of chemistry or pharmaceutical chemistry, with minimum 5-8 years of experience in the biotechnology/pharmaceutical industry
  • Experience in analytical test method development, transfer, qualification and validation of small molecule pharmaceutical products
  • Hands‐on experience with analytical methodologies used for analysis and characterization of small molecule pharmaceuticals, such as HPLC, GC, UV, LC-MS, FTIR and dissolution
  • Knowledge of Quality Systems and current FDA regulations and ICH guidelines
  • Experience writing analytical characterization related sections of IND/NDA submission a plus
  • Proficient with instrument trouble-shooting for HPLC, GC and LC-MS
  • Must be highly organized and have the ability to communicate effectively with internal and external organizations
  • Highly motivated team player willing to contribute to a growing biopharmaceutical company

Level:

Scientist l or Scientist ll will be considered based on the experience level of the selected candidate.