Process Development Associate (Protein Purification/Cell Culture)

Description

**100% on-site in Thousand Oaks, CA** Working hours: 8 AM- 5 PM or 9 AM - 6 PM with 1 hour lunch

The Pre-Pivotal Drug Substance Technologies organization develops, characterizes and supports clinical drug substance manufacturing processes for all early-stage programs in the portfolio.

*Must have lab experience at least one year working on similar projects*

This lab-based position is located at our Thousand Oaks, CA site. The successful candidate will be responsible for support of the development, characterization, scale-up and support of upstream and downstream processes to enable clinical advancement of programs.

This role is in an integrated bioprocess development group in which cell culture and purification scientists work together to rich, exciting and dynamic pipeline. With biology first approach, the position provides the unique opportunity to work on multiple modalities including antibodies, BiTEs, oncolytic viruses, bispecifics, and siRNAs.

The successful candidate will design and execute experiments at the bench scale, spanning the end-to-end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to technology development, including process automation. Finally, the candidate will also expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group.

Preferred Qualifications:

Master’s degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence.

Ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment.

Basic understanding of protein chromatography, filtration or cell culture principles; hands-on experience with mammalian cell culture, and/or purification operations is a plus.

Prior experience with data analytical tools (Excel, Spotfire, etc.) is preferred. Experience with statistical analysis and programming in JMP, R, and/or Python environments is a plus.

Motivated self-starter with excellent interpersonal and organizational skills.

Team player with the ability to successfully work within a diverse team in a dynamic, cross-functional environment.

Familiarity with design of experiments and statistical analysis of data desirable.

Basic Qualifications

Bachelors degree OR Associates degree and 2 years of experience OR High school diploma / GED and 4 years of experience

Top 3 Must Have Skill Sets:

• Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing field or relevant experience in the pharmaceutical or related industry preferred.

• Relevant hands-on lab experience in cell culture or protein purification.

• Attention to details and critical thinking ability.

Day to Day Responsibilities:

• Work in a team environment to contribute to drug substance process development.

• Complete mammalian cell culture experiments at different scales in shake flasks and bioreactors.

• Implement purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed.

• Document experimental data in lab notebooks.

• Analyze the data and present to the team.

• Author technical reports and support regulatory filing as needed.

• Contribute to technology development projects to seek continuous improvement in reliability and efficiency.

• The candidate will have opportunities to work in cell culture development and purification development to become a well-rounded process development scientist with experience in upstream and downstream.