Research Scientist I
Hayward, CA
Req ID 48345BR
Business Title
Research Scientist I
Business
BioScience
Sub-Business
Manufacturing
Country
US
State/Province
California
Location of Position
Hayward, CA
Shift_
1st
Job Description
Baxter is seeking a talented research scientist to join our PD analytical development group located in the Hayward, CA facility. The successful candidate will be an expert in analytical development of various methods to fulfill analytical needs from process development, technical services, manufacturing, and quality control. She/he will play an important role in the development of a wide variety of assays suitable for GMP testing, and important for Hayward manufacturing operation.
Major Responsibilities include:
1. Develop analytical assays and transfer the assays to QC for cGMP product release testing of therapeutic antibody, protein products;
2. Adopt, improve the assays that are transferred from external labs to Hayward PD, and transfer reliable assays to QC suitable for QC performance and cGMP testing;
3. Identify, develop state-of-the-art analytical methods for therapeutic antibody, protein product characterization, comparability and stability studies, as well as for improving efficiency of in-process and product release testing;
4. Perform routine assays to support upstream cell culture and downstream purification process development work; Troubleshoot various PD and QC assays to support routine PD, QC, and manufacturing operation;
5. Collaborate with the internal & external technical operational teams for developing & troubleshooting and improving additional analytical methods important for Hayward and Baxter Bioscience operation;
6. Write technical reports, technical summaries, investigational reports, and assay SOPs for various projects.
7. Make detailed observations, analyze data, interpret results, and exercise appropriate technical skills in the design, execution, and interpretation of studies in an independent manner.
8. Lead research associate(s), work closely with the associate(s) to deliver the results to meet project timelines, milestones.
Job Requirements
1. Demonstrated assay development, qualification and validation experience in the therapeutic antibody, protein field, and a demonstrated track record of successfully developing analytical methods in the cGMP environment, and transferring the assays to Quality Control for GMP release testing of therapeutic antibody, and protein drugs;
2. In-depth knowledge, extensive hands-on experience and demonstrated expertise in the development and validation of ELISA based assays (potency/activity, impurity), and Electrophoresis based assays (SDS-PAGE, western blot, IEF). Additional experience with Capillary electrophoresis (CEIEF, CE-SDS) and HPLC method development (SEC, IEX) is a plus.
3. Demonstrated management experience (2 yrs. minimum) in mentoring research associate(s) .
4 . Strong analytical and organizational skills; adequate statistical skills, and an ability to handle multiple projects to meet various project timelines .
5 . The candidate is also expected to work independently, multitasking, trouble-shooting technical issues as well as carry out routine assays at bench and work with the associate(s) and other analytical members in the group. The candidate must have excellent written, oral, presentation, communication skills, good time management and organizational skills, excellent teamwork and interpersonal skills, as well as an ability to work in a fast-paced team-centered environment. The candidate will be expected to present findings at internal and/or external meetings, serve as a mentor and role model for other lab personnel.
Education:
Bachelor's degree in a scientific discipline with at least 10 years, MS with at least 5-7 years, or PhD with at least 2 years in relevant discipline required.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
