Associate Scientist, Analytical Development (Large Molecules)
BioDuro-Sundia, United States
Job Description
Job Title: Associate Scientist, Analytical Development (Large Molecules)
Department: Analytical Development
Reporting To: Director, AD
Classification: Full-Time, Exempt
Salary: $64,480
What We Do
BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 10 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.
Why BioDuro-Sundia?
Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.
Job Overview/Summary
This role is responsible for assisting our Senior Scientist in the analytical development and characterization activities in support of our projects for biologics. You will be assisting in creating the analytical strategy for the manufacturing of biotherapeutics by developing test methods, method transfer, specifications, and good documentation.
It will require experience with SDS-PAGE analysis, gel-based assays, potency assays or/and molecular biology techniques.
Essential Functions and Responsibilities
- Assist analytical development and characterization activities in support of our projects for biologics.
- Assist method development strategies for SDS-PAGE analysis.
- Assist in the lab to execute potency assays, ELISAs, dissolution testing, UV -spectrophotometer assays.
- Assist other routine assays in the lab not limited to HPLC analysis, water content analysis, residual solvent analysis.
- Perform in-house analytical development and protein characterization, and partner with the senior scientists.
- Work with QC, and Analytical Scientists to develop, implement and transfer appropriate analytical methods internally.
- Write and review SOPs.
- Validate methods according to ICH guideline.
- This job description is subject to change at any time.
Requirements
- A degree in Analytical Chemistry, Biochemistry, Cell Biology, or related field
- 0-2 years of experience in analytical development for the pharmaceutical industry;
- Working knowledge of analytical techniques, such as HPLC, GC, UV/Vis, ELISA, Activity, SEC.
- Extensive experience with the analysis of protein therapeutics and a working knowledge of small molecule analytical methods.
- Demonstrated expertise in the independent design and execution of analytical development projects.
- A working knowledge in the interpretation and application of international regulatory guidelines in different phases of drug development.
Benefits
We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.
EOE and Accommodation
We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing . If you are selected to interview for a position, you may also request an accommodation with our team directly.