Planet Pharma
Senior Analyst, Quality Control Chemistry
Responsibilities include:
Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g., HPLC, LCMS, AUC, UV, CE‑SDS, compendia methods like Osmolality, pH, Sub visible particulates, Appearance).
Review and approve cGMP analytical data for release and stability testing from chemistry analytical test methods.
Support and lead QC Chemistry laboratory operations (e.g., instrument qualification and maintenance, housekeeping, qualification of critical reagents).
Author and support quality events; change controls, deviations, CAPA, OOS investigations, as needed.
Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), method transfer/validation protocol, method transfer/validation report for internal and external methods.
Method transfer / validation of QC chemistry methods at internal and external laboratories.
Model leadership behaviors and mentor/training junior staff.
Job responsibilities may change as needed to support activities relevant to the clinical phase.
Qualifications
Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.
BS/MS in Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment.
Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologic materials using HPLC/UPLC, LCMS, AUC, UV‑Vis, CE‑SDS is strongly preferred.
Experience working with external contract labs (CMOs, CROs) is a plus.
Strong collaboration and team‑working skills.
Strong communication, interpersonal and organizational skills.
Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
Highly motivated, demonstrate good technical skills, excellent organizational and communication skills, and able to multitask in a fast‑paced environment with changing priorities.
Seniority level: Mid‑Senior level.
Employment type: Contract.
Job function: Other.
Industries: Pharmaceutical Manufacturing and Biotechnology Research.
Benefits: Medical insurance, vision insurance, 401(k).
#J-18808-Ljbffr
Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g., HPLC, LCMS, AUC, UV, CE‑SDS, compendia methods like Osmolality, pH, Sub visible particulates, Appearance).
Review and approve cGMP analytical data for release and stability testing from chemistry analytical test methods.
Support and lead QC Chemistry laboratory operations (e.g., instrument qualification and maintenance, housekeeping, qualification of critical reagents).
Author and support quality events; change controls, deviations, CAPA, OOS investigations, as needed.
Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), method transfer/validation protocol, method transfer/validation report for internal and external methods.
Method transfer / validation of QC chemistry methods at internal and external laboratories.
Model leadership behaviors and mentor/training junior staff.
Job responsibilities may change as needed to support activities relevant to the clinical phase.
Qualifications
Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.
BS/MS in Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment.
Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologic materials using HPLC/UPLC, LCMS, AUC, UV‑Vis, CE‑SDS is strongly preferred.
Experience working with external contract labs (CMOs, CROs) is a plus.
Strong collaboration and team‑working skills.
Strong communication, interpersonal and organizational skills.
Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
Highly motivated, demonstrate good technical skills, excellent organizational and communication skills, and able to multitask in a fast‑paced environment with changing priorities.
Seniority level: Mid‑Senior level.
Employment type: Contract.
Job function: Other.
Industries: Pharmaceutical Manufacturing and Biotechnology Research.
Benefits: Medical insurance, vision insurance, 401(k).
#J-18808-Ljbffr