Planet Pharma · 21 hours ago
Senior Analyst, Analytical Quality Control
Newark, CA
Full-time
Onsite
Senior Level
$50/hr - $62/hr
6+ years expPlanet Pharma is focused on ensuring the integrity and quality of drug substances and products. The Senior Analyst in Analytical Quality Control is responsible for testing raw materials and finished goods, maintaining compliance with cGMP standards, and collaborating with cross-functional teams to resolve quality issues.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
Performing and reviewing of chemical/bioanalytical tests, specifically HPLC (Cation Exchange, Size Exclusion, Reversed Phase) for raw materials, intermediates, and drug substance and drug products for release and stability programs
Accurately record, analyze, and report results, identifying any deviations from specifications and procedures
Write/review SOPs, protocols, assay worksheets, stability reports, and quality records such as laboratory investigations, deviations, CAPAs, and change controls
Ensure the laboratory is in cGMP compliance with regulations (e.g., FDA and CDC), pharmacopeia standards, and established procedures
Maintain laboratory space to regulatory expectations and internal procedures regularly, including support of equipment qualification and onsite vendor support
Conduct root cause analysis for quality issues and collaborate with cross-functional teams for resolutions
Manage lab supplies and samples
Ensure a safe and secure laboratory environment, providing training to junior analysts on laboratory procedures and assays
Work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Analytical Development, to resolve quality issues and support process improvements
Qualification
Required
Bachelor of Science in Biochemistry, or a related pharmaceutical biotechnology discipline
6+ years of regulated pharmaceutical industry experience
Must have experience with a range of biological and physicochemical methods
Must have experience in peer-reviewing of Quality Control data
Must have experience with a wide range of HPLC methodologies (CEX, SEC, RP-HPLC)
Experience with HPLC for peptides is a plus
Preferred
Master of Science in Biochemistry, or a related pharmaceutical biotechnology discipline
Experience with a range of biological and physicochemical methods (pH, ELISA, Western Blot, SDS-PAGE, HPLC)
Experience authoring and revising HPLC SOPs, HPLC methods, CR/DR/CAPAs, and technical writing
Proficient understanding of data integrity and ALCOA+ principles
Effective written and verbal communication skills
Experience supporting analytical instrumentation calibrations (work orders, reports, etc.) with vendors is a plus
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase