Newark Metro Area, NJ
Responsibilities include, but are not limited to, the following:
- Performs the daily operations of the Stability Program under the direction of the Director, Analytical Development.
- Assists the Stability Scientists in the performance of their responsibilities for the organization, maintenance, operation, and data review required for the Drug Stability Program which is utilized for the evaluation of the stability of developmental pharmaceutical drug substances and drug products. This program maintains the stability protocols for all developmental and clinical drug substances and drug products according to ICH/FDA guidelines and approved submissions/commitments.
- Is well-versed in the operation of a Stability function and able to independently undertake major project assignments and drive them to completion with a minimum of supervision.
- Is technically experienced and is a valued resource within the department.
- Assures that stability samples for all projects have been properly placed on stability at the correct stability conditions. Follows the requirements of the Stability Protocols and helps maintain all required timelines (sample maintenance and documentation of test results). Helps maintain stability documentation, as required. Interacts with the QC and R&D laboratories as well as with the appropriate Quality Assurance, Technical Operations and Regulatory areas as necessary.
- Is responsible for the accurate and timely tracking of stability data. Has a background in the statistical evaluation of Stability data and can effectively trend this data utilizing programs designed for this function.
- Helps maintain Stability data evaluation and the timely delivery of customer-oriented data and documentation.
- Is able to effectively review analytical data to recognize potential trends and alert the Stability Director.
- Compliance Systems: Helps maintain the activities of the Stability Area in compliance with cGMPs, SOPs, good documentation practices and safety standards in accordance with Corporate, Regulatory and timeline expectations.
- Stores, maintains inventory and requalification schedules, creates and updates Purity Statements, performs distribution of Reference Standards and Reference Materials for developmental and commercial products.
- Creates Stability Reports to summarize stability data for developmental drug substances and drug products and facilitates the joint review and approval by the SMEs from Analytical Development and Quality Assurance.
- Responsible to streamline and continuously improve stability operations including stability reports, creation, revision of Stability SOPs and processes for efficiency and cGMP compliance.
- Ensures maintenance of continuous cGMP compliance in day to day Stability Operations by themselves and others below their level such as Associates Scientists.
- BS in Analytical Chemistry or related scientific discipline with 10+ yrs, MS with 8-10 yrs, or Ph.D. with 5+ yrs. of work experience within a Stability function in pharmaceutical industry is required.
- Experienced in the evaluation of analytical data including statistical interpretation of Stability data for shelf-life/re-test period determination and trending.
- Working knowledge in stability LIMS (e.g.- LabWare) is strongly desired
- Well-versed in cGMP requirements
- Good working knowledge of common MS software
- Excellent verbal and written communication skills