Company: Confidential
Job Title: RA/SRA, Analytical Dev. & QC
Job Number: 33163
Location: , CA
Job Description
Responsibilities
- Performing regular and irregular analyses on samples of in-process, toxicology, finished drug substance and drug product, such as release and stability testing.
- Oversee the progress of new and ongoing development projects
- Review analytical data for adherence to SOPs
- Participate in internal and external scientific meetings
- Collecting and documenting data for quality review
- Revising SOPs as necessary, authoring qualification/validation protocols and reports, as well as scientific reports and portions of regulatory filings in the Chemistry, Manufacturing, and Controls (CMC) section
- Conducting analytical investigations and potentially developing and optimizing analytical methods
- Knowledge of cGMP and GLP standards and practices
- May be responsible for managing one or more direct reports
Required Skills
- A bachelor’s or master’s degree in Chemistry or a related field
- A minimum of 5 years of experience in an analytical development and quality control role for a Research Associate, and a minimum of 10 years for a Senior Research Associate
- Practical knowledge of HPLC, MS, and GC
- Familiarity with cGMPs is preferred
- Experience in following SOPs for Analytical Methods, Equipment Procedures, and Material Specifications
- Ability to act as the technical leader of a scientific project
- Capability to independently interpret experimental results and determine a path forward
- Strong organizational abilities
- Experience recording data in laboratory notebooks or data collection forms
- Comfortable with operating and troubleshooting laboratory equipment and instrumentation
- Effective communication skills, both written and verbal, to interact with all levels of the organization
- Ability to meet deadlines and workloads and complete assigned tasks
- Willingness to be flexible in job duties to support team objectives
- Experience in managing development projects
- Willingness to promote positive teamwork, encourage solutions, and seek feedback to resolve issues while demonstrating respect to others
- Active listening skills and the ability to provide constructive feedback to suggestions or opinions presented.
Compensation and Benefits:
Salary range: $80,000 to $115,000/year
Benefits:
Health Insurance (medical, dental, vision)
Life Insurance
Short- and Long-Term Disability
401(k)
Paid Time Off (PTO) – 3 weeks PTO and 16 Paid Holidays
Apply for job
To apply for this job please visit k7y.pl.