Job Description
Use Your Power for Purpose Seeking a detail-oriented person to work with members of the Quality Stability Program Management team to support the design, development, implementation and maintenance of stability protocols and studies for a commercial product and a variety of late phase clinical products both internal and at external manufacturing facilities. This position will include the comprehensive review and assessment of stability data (including trending and analysis), providing quality stability reports suitable for regulatory submission, and authoring stability sections of regulatory documents in support of IND's, BLA's, PMA's, MAA's, etc. In addition, the candidate may be required to represent the department at internal meetings or during regulatory regarding product stability information and data . The Stability Specialist IV has a strong understanding of corporate and regulatory requirements necessary to support stability programs. Independently analyzes stability data to assure product specification and conformance to regulations are met. Recognizes atypical or out-of-specifications test results and notifies management immediately. The Stability Specialist IV has knowledge of stability procedures and systems, performs a variety of complex tasks in compliance with cGMP's. Analyzes and interprets stability data and test results, as well as prepares data for statistical analysis and writes stability reports and annual reports. Leads investigations and troubleshoots stability issues. Interacts with others to support stability activities and mentors team members. What You Will Achieve Responsible for development, implementation and maintenance of stability protocols and studies for a variety of late phase clinical as well as commercial products Responsible for enrollment of new and existing products for annual commitment and Process Validation Stability Studies Responsible to author cGMP stability protocols, reports and request forms Responsible for managing stability of products produced internally as well as by a contract manufacturing facility Responsible for change controls, annual reports, APQRs, YBPRs, regulatory filings and technical reports. Managing stability studies and data in LabWare LIMS Preparing information for and supporting regulatory audits. Identifying stability related issues and solve these under the guidance of the Manager. Analyzing and interpreting stability data and test results and participates in the decision if follow-up actions are required The successful candidate must be able to work independently on multiple projects and meet established timelines. Represent the department on inter-departmental project teams that are developing/improving processes and systems to ensure compliance with cGMPs and anticipate the introduction of new requirements With a strong knowledge of stability procedures and systems, independently perform a variety of routine and non-routine tasks in compliance with cGMP’s Lead/co-lead stability projects for new product introduction, change controls for shelf life extension and regulatory responses Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team Act as a stability subject matter expert (SME) within the stability team and on cross functional teams Independently identify new ideas and lead/co-lead the work to evaluate and implement A decision maker for stability impact assessments on investigations, temperature excursions and change controls. Partner with members of QC, QA, Pharmaceutical Sciences on stability program design and post market changes. Identifies areas of improvement within the business and may lead continuous improvement activities Promote a culture of innovation and continuous improvement. Serve as a stability SME to review work completed by other colleagues in other areas. Provide guidance and training to more junior staff members on stability guidance and procedures. Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience 2-4 years of stability program experience required. Relevant Quality experience, preferably in the bio/pharmaceutical industry. General knowledge of stability and cGMPs. An understanding of biologics stability testing, FDA, ICH, and applicable stability regulations is required.