Supervisor, Quality Control Analytical

Curia • Hopkinton, MA

5d • $97,000 - $120,800

About The Position

The Quality Control Supervisor is responsible for overseeing routine and
non-routine analytical chemistry assays of raw materials, in-process samples,
finished APIs, and/or special projects. This role will oversee the day-to-day
functions of their department and manage a team of Quality Control Analysts.
This position may require work outside of normal business hours as needed.

Curia is a global contract development and manufacturing organization (CDMO)
with over 30 years of experience partnering with pharmaceutical and biotech
companies to provide life-saving treatments to patients. At Curia, we are on a
mission to advance our customers’ therapies from curiosity to cure and
ultimately to improve patients’ lives.

Requirements

• BA/BS Degree and a minimum of 3 years’ relevant related work experience, plus 3 years in a team leadership role, OR
• MA/MS Degree and a minimum of 1 year of relevant related work experience, plus 3 years in a team leadership role
• Chromatography: SEC-HPLC, UPLC, and related methods for purity and impurity analysis
• Electrophoretic techniques: CE-SDS, cIEF (e.g., Maurice/PA800 platforms) for protein characterization and charge/size variants
• Ligand-binding assays: ELISA (e.g., potency, HCP, residual Protein A) and/or Octet/BLI for binding and functional characterization
• Molecular methods: qPCR-based assays (e.g., residual DNA, mycoplasma)
• Biochemical assays: UV/Vis, mBCA, pH, conductivity, osmolality, and general wet chemistry techniques
• Product quality assessments: visual appearance, subvisible particles, and integrity testing
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Responsibilities

• Manage the Quality Control Team Performance of analytical testing for various samples and incoming, in process and final products
• Ensure that the analytical chemistry functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
• Supervise a team of analysts including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
• Ensure that laboratory operations are conducted in a safe manner.
• Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary
• Organize workloads and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
• Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs
• Supervise and perform pharmaceutical analysis to support drug substance manufacturing

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees