Stability Coordinator I

Stability Coordinator in Rensselaer, NY Build your future at Curia, where our work has the power to save lives 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. We proudly offer

• 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!

The Stability Coordinator is an integral part of the Curia team. The principal responsibility of the Stability Coordinator is to provide technical, organizational and compliance support for ongoing and prospective stability studies.

MAJOR DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Review of analytical data and documentation for compliance with cGMPs, Curia SOPs and other written procedures. Primarily chromatographic data, but also instrumental testing such as DSC, XRPD, water analysis, USP testing, etc. Identification of deviations. Trending of stability data to ensure consistency with historical timepoints and no unexpected results.
• Managing timelines and multiple projects: Interface with scientists and management to coordinate testing timelines, corrections to documentation, and reporting within defined turnaround times. Adjusting priorities based on due dates and invoicing goals.
• Writing stability protocols.
• Interfacing between sites (Albany and Rensselaer) to coordinate testing for efficiency and use of site-exclusive equipment.
• Direct, technical communication with customers (primarily, external). Reporting results, technical discussion, addressing questions.
• Formatting and review of reports: Stability Summary tables; accuracy and compliance with current Curia formats.
• Managing invoicing for stability: request of POs for contract laboratories, issuing BRFs, working with finance to ensure accurate and complete accounting for stability projects, review of monthly invoices. Tracking monthly and quarterly financial projections.
• Controlled substances handling including maintaining inventory, paperwork, biannual review.
• Manage quality investigations (e.g., deviations) as necessary.
• Manage workload and time to enable the incumbent to perform multiple projects effectively, and ensure all necessary paperwork is completed on a timely basis.
• Volunteer to assist with other tasks in the analytical function not directly related to specific projects.
• Participate in self-development activities and training of others.
• Perform other related duties as may be reasonably assigned in the course of business.
• Future: writing proposals and designing studies for stability.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and experience Required

• Bachelor’s degree in a relevant field with major in Biology, Chemistry, Natural Science or Pharmacy or equivalent required with minimum of 2+ years of previous professional experience
• Good knowledge of analytical chemistry including wet chemistry and instrumental methods of analysis.
• Strong computer and math skills.
• Demonstrated written & verbal skills
• Technical troubleshooting skills
• Critical thinking & problem-solving skills such as DMAIC
• Analytical data review
• Experience with ERP, LIMS and document control systems preferred

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Pay Range: $48,900 - $63,000 Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.