Pfenex is a clinical stage development and licensing biotechnology company focused on leveraging our
Pfenex Expression Technology platform to develop and improve protein therapies for unmet patient needs. Our dynamic team is comprised of talented individuals who bring passion to our purpose and commitment to the cause.
Pfenex is looking to bring on a contract Associate Scientist II to join the Analytical Sciences team. As a key member of the Analytical Sciences Group, the Associate Scientist II is responsible for executing analytical and biochemical characterization activities for biotherapeutic product development, including method development, method qualification, and physicochemical product assessment. This position must effectively adhere to timelines and communicate issues to ensure successful product development, product testing, and data package generation for regulatory filings. Individual technical issue management and cross functional communication are key position attributes. The candidate will work in a team environment, collaborating with various departments to ensure that analytical methods are properly developed and qualified to support product quality, achieve project goals, and timelines.
ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES
- Support the development and commercialization of biotherapeutics through the application of analytical methods involving HPLC separations, SDS-PAGE, Western blots, UV-Vis spectrophotometry, and other protein characterization methods.
- Responsible for developing method robustness and other analytical parameters prior to analytical method Tech Transfer to QC CMO for validation.
- Facilitate method transfers between Pfenex & CMO and/or Pfenex partner.
- Keeps current in analytical method development including literature and technology development and regulatory driven activities
- Author/Review detailed analytical reports and provides direct input/data/statistical analysis to support data package for regulatory submission(s).
- Interface with contract manufacturing or research organizations (CMOs/CROs) in the execution of analytical method transfer, testing, and release and stability studies.
- Other duties as assigned or required
JOB SKILLS, ABILITIES AND QUALIFICATIONS
A minimum of a Bachelor's degree in Analytical Chemistry/Biochemistry/Biochemical Engineering with biologics experience required
- BS in Biology/Analytical Chemistry/Biochemistry/Biochemical Engineering or related field
- BS 5 years of relevant experience w/a minimum of 5 years of industry experience
- Proven ability to demonstrate Good Documentation Practices in lab notebooks, reports, and overall data generation.
- Fluent in practical application of PC's, Microsoft project, Word, Excel, Power point
- Experience in developing and qualifying analytical methods, primarily HPLC separations
- Scientific understanding of current analytical technologies, as well as the ability to explore and develop novel approaches to further advance innovative analytical methodologies
- Working knowledge and understanding of GxP (GLP, cGMP, GCP and ISO9000) environments and regulations
- Ability to work flexible work schedules
- Excellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic
- Work independently and successfully in a matrix environment; and prioritize and manage multiple tasks simultaneously
- Affirmative Action and Equal Opportunity Employer (EOE)
- No agencies or phone calls please
- Pfenex celebrates the diversity of life and welcomes all individuals to apply
- Must be legally authorized to work in the US without sponsorship