What are the responsibilities and job description for the Senior Analyst, Quality Control Chemistry position at Planet Pharma?
Woburn, MA - ONSITE
6 month extendable CONTRACT
$42 - $48 per hr
Responsibilities
o 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 and Appearance)
o Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods
o Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc).
o Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
o 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.
o Method Transfer / Validation of QC chemistry methods at internal and external laboratory.
o Model leadership behaviors and mentor/train junior staff
o The job responsibilities may change as needed to support activities relevant to the clinical phase.
Qualifications:
o Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.
o BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment.
o Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS is strongly preferred.
o Experience working with external contract labs (CMOs, CROs) is a plus.
o Strong collaboration and team-working skills.
o Strong communication, interpersonal and organizational skills.
o Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
o Should be highly motivated, demonstrate good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
Salary : $42 - $48