Research Associate I/II

Job Title: Research Associate I/II

Job Number: 34001

Location: Carlsbad, CA

Job Description

We are looking for an RA I/II to come join our team and perform HPLC, MS and analyses of samples.

Responsibilities

• Perform regular and special analyses on samples from various stages of drug production, including in-process, toxicology, finished drug substance, and drug product samples for release and stability testing. 
• Oversee both new and ongoing development projects.
• Evaluate analytical data to ensure it complies with standard operating procedures (SOPs), such as those related to analytical methods, equipment procedures, and material specifications.
• Participate in both internal and external scientific meetings, and present findings when necessary.
• Compile and document data for quality assessment purposes.
• Modify SOPs when required, including those related to analytical methods, equipment procedures, and material specifications.
• Create and carry out qualification/validation protocols and produce corresponding reports.
• Author scientific reports and contribute to the Chemistry, Manufacturing, and Controls (CMC) section of regulatory submissions.
• Conduct analytical inquiries and investigations.
• Possibly develop or enhance analytical methods.
• Utilize knowledge of current Good Manufacturing
• Practice (cGMP) and Good Laboratory Practices (GLP) on a daily basis.

Required Skills

1. A Bachelor's or Master's degree in Chemistry or a related field.
2. For the Research Associate I role, 0 to 4 years of experience in analytical development and quality control is required, while the Research Associate II role calls for 5 or more years of experience in the same field.
3. Practical familiarity with High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), and Gas Chromatography (GC).
4. Preferably, a background in and previous application of current Good Manufacturing Practices (cGMPs).
5. Proficiency in adhering to Standard Operating Procedures (SOPs), specifically those related to Analytical Methods, Equipment Procedures, and Material Specifications.
6. The capability to serve as a technical leader for scientific projects.
7. The ability to independently interpret experimental results and determine the appropriate course of action.
8. Strong organizational skills.
9. Experience with recording data in laboratory notebooks or data collection forms.
10. Comfort with operating and troubleshooting laboratory instrumentation and equipment.
11. Effective communication skills, both orally and in writing, with individuals at all levels within the organization.
12. The capacity to complete assignments, meet deadlines, and adhere to time schedules.
13. Flexibility in managing workloads and tasks to support team goals.
14. Previous experience in project management.
15. A track record of fostering positive teamwork, promoting problem-solving, seeking feedback, and demonstrating respectful behavior towards colleagues.
16. Active listening skills and the ability to provide constructive feedback in response to suggestions or opinions presented.

Salary range: $62,000-$103,000 per year

Benefits:
Health Insurance (medical, dental, vision)
Life Insurance
Short- and Long-Term Disability
401(k)
Paid Time Off