CMC Stability Manager

Location
94520, Concord
Posted
Mar 16, 2018
Required Education
Bachelors Degree
Position Type
Full time

Responsible for all phases of the product stability testing program to include devices, components, drug substance, and drug product.  Manage new and ongoing studies conducted at third-party vendors necessary to ensure complete and accurate data is available for establishing storage requirements and expiration dating periods for all products and in-process materials. Convert raw data into stability reports to support regulatory filings. Responsible for interacting with contract manufacturing partners (CMOs) as needed to refine and review stability protocols and reports. Provide support to CMO and Cerus staff in the preparation and review of protocols and reports for analytical methods and process validations. 

Primary Responsibilities:

  • Develop, coordinate and maintain all phases of the product stability testing programs. In conjunction with CMOs, produce stability protocols in accordance with ICH, FDA, and regional country requirements. Manage the completion of summary reports at the conclusion of each testing timepoint and at conclusion of each stability study.

  • Familiarity with commonly utilized analytical instrumentation used to generate stability data. Strong working knowledge of chromatographic methods and compendia (USP and EU) techniques such as Karl Fischer, particulate matter, IR, etc.

  • Evaluate laboratory results critically by comparing to established specifications, acceptance criteria, and historical trends. Ensure product is safe, effective, and meets established Cerus and customer quality standards as needed. Recognize, record and investigate unexpected laboratory developments (e.g. OOS, OOT). Initiate and complete change control projects as necessary.

  • Evaluate and trend stability data to justify retest dates for clinical trial materials by compiling high quality CMC data packages to be supplied to QA.

  • Provide technical expertise during Cerus specification committee meetings in the form of data analysis and trending to set appropriate clinical and commercial specifications.

  • Follows the requirements of the stability protocols, maintains stability calendar and all stability related documentation. Update and publish stability calendar to key stakeholders on a monthly basis.

  • Summarize stability results, trend data, and distill complex cause-and-effect relationships into concisely written text supporting high quality regulatory submissions.

  • Build strong working relationships externally with contract partners and internally with cross functional (RA, QA, Supply Chain, Development, etc.) team members to ensure timely and high-quality information flows smoothly within the organization in all directions.

  • Revise and update standard operating procedures and product specifications as needed.

  • Provide leadership related to special projects utilizing technical problem solving skills.

    Review and approve test data, qualification/validation/verification data, qualification/validation/ verification protocols, and qualification/validation/verification reports.

  • Other duties as assigned.

Requirements

  • Bachelor or Master’s degree in a scientific discipline (Analytical Chemistry highly preferred). A minimum of 5+ years’ experience with Bachelor’s degree or 2+ years with Masters.

  • Thorough understanding of ICH stability/ follow up stability testing requirements and experience with device or pharmaceutical FUST.

  • Experience in stress, accelerated, photostability, and aging/distribution testing for products.

  • Experienced in the evaluation of analytical data, including statistical interpretation of stability data, with ability to assist others in this area.

  • Experience in various chromatography data system (CDS) and Laboratory Information Management System (LIMS) software applications is highly desirable (EMPOWER, LabWare, ViewLink or like systems).

  • Prior experience developing, managing and running a stability program preferred.

  • Must be highly organized, detail oriented and able to manage multiple projects.

  • Must have in-depth understanding of various analytical instruments (HPLC, GC, MS, UV, IR, etc).

  • Proficient in office software (MS Excel, MS Word, Minitab, etc) and compliance level record keeping.

  • Motivated and flexible to work in a dynamic group.

  • Strong problem solving capability in analytical chemistry.

  • Strong written and verbal communication, organization and prioritization skills.

  • Ability to handle multiple priorities in a project driven environment.

  • Ability to maintain detailed and accurate records.

Limited travel domestically and internationally to support activities at CMO partners may be required.