Unigene Laboratories Inc. Work Values

Daily Duties at Unigene Laboratories Inc.:

Oversee the planning, design, execution, assessment, and documentation of analytical method development and validation experiments using a wide variety of analytical instrumentation and techniques to meet regulatory requirements. Lead method development and validation projects and Quality Control project teams of up to 4 people. Troubleshoot analytical method and instrumentation problems, write and revise analytical procedures, lead and document analytical investigations, and provide technical assistance to Quality Control and Quality Assurance in OOS/Laboratory Investigations. • Managed stability testing for a client’s post Phase 3 solid oral dosage product in support of an NDA application. • Improved efficiency and managed project alterations under strict time constraints. • Lead development and validation of analytical methods, and subsequently trained the QC staff in those methods. • Effectively initiated changes to validated dissolution procedure that resulted in double output and made difficult deadlines consistently achievable; acted as the liaison between QC, QA, and the Client/Sponsor. • Led an extensive study that involved performing a variety of dissolution analyses to generate F2 curves to demonstrate equivalency between manufacturers according to SUPAC guidelines. • Successfully developed and validated an oral dosage form dissolution method utilizing a novel non-compendial apparatus, cutting raw material costs for testing by 60%, and reducing assay analysis time by approximately 70%. • Maximized efficiency during development processes which allowed one analyst to complete both the testing phase and the documentation within one day, a process that normally took 3 analysts 2-3 days to complete in the past. Resulted in increased productivity of 2 junior quality control analysts by 300%. Senior Quality Control Associate (March 2008 – March 2009): Performed quality control analytical testing on a variety of dosage forms following company SOPs. Participated in preparation of assay development reports, SOPs, analytical procedures, and method/stability protocols. Performed and ensured product release, and conducted stability testing activities within given timeframes, as well as method development studies, scale up, and post-approval testing for solid oral dosage forms. Maintained laboratory inventory. • Contributed to the creation and execution of numerous method development, equipment qualification, and validations for HPLC analyses and dissolutions. • Ensured quality control laboratory and equipment compliance with cGMPs by updating and reviewing equipment qualifications, standard operating procedures, analytical methods, and stability studies. • Initiated, investigated, and proposed corrective actions for laboratory investigation reports for out-of-specification results to ensure the timely completion and submission for supervisory review. • Achieved accuracy, completeness, and compliance with departmental SOPs by reviewing work of colleagues. • Consistently promoted into leadership positions with increased responsibilities due to superior performance.

What they like about Unigene Laboratories Inc.:

The social vibrance of a hiring firm is very important to you. Your ability to make and maintain friendships there is a critical part of your decision. You would likely be dissatisfied with a workplace that is quiet, cold, or otherwise not particularly social. When you investigate a new hiring company, ask recruiters, managers, and potential co-workers about the social life and opportunities there. This is especially important when you are relocating; moving dramatically alters your social sphere both inside and outside the workplace.

Tags

CMC, Project Manager, NDA , Post Approval, Supervisor, CTD, Regulatory Affairs, RAC, Consultant, IND, Specialist

Skills

CMC, Management, Project Planning, Document Management Softwares, Cross-functional team management, CTD, eCTD, Regulatory Affairs, Post approval changes

These are some of the questions we asked our climbers about their experiences with Unigene Laboratories Inc.: