Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
This position is responsible for managing operational aspects of the ongoing stability program, as well as implementing new stability studies. In addition this position is responsible for data management and trending of all release data.
This includes management of stability samples and review of data from contract labs, ensuring policies and procedures are up to date and followed to provide an audit ready GMP work environment, and working with IT personnel to ensure LIMS and associated software meets the needs of the stability group. Coordination of testing for both release and stability samples, as well as subsequent data management.
- Upholding the operations area to highest standards of quality, safety, security
- Point person for stability software and LIMS / IT Systems. Subject matter expert and support change control, as needed, working with IT personnel
- Stability software and LIMS user and eventual subject matter expert for the group
- Authors user requirements and manages new software version testing
- Tracking Product programs schedule vs. Actual, Timing
- Program Status (study starts, workload distribution, metrics, etc.)
- Monitor delivery of approved results in accordance with Quality Service Agreements
- Developing and managing continuous improvement projects
- Problem solving and troubleshooting to resolve issues related to Operations, Quality, or LIMS;
- Assist with quality investigations and implementation of CAPAs, working with the Quality Unit
- Manages procedural document creation and revisions
- Candidates are sought with broad experience and depth of knowledge in pharmaceutical quality control and stability operations, quality systems and LIMS operation. Statistical evaluation of data a plus.
- The successful candidate will be a self-starter and have demonstrated ability to make decisions independently.
- A B.S. degree in the Life Sciences (Biology, Chemistry, Pharmacy), Engineering, or in a related science area, with a minimum five (5) years of experience in the pharmaceutical industry.
- Must have strong organizational/follow-up and planning skills
- Good interpersonal and communication skills (verbal and written)
- Attention to detail and ability to work within safety procedures.
- An understanding and knowledge of quality systems, documentation practices, and equipment IQ/OQ/PQ in a cGMP regulated environment is required.
- Functional understanding of the pharmaceutical product development process is desired.
- The candidate should have a basic understanding of mechanical systems and electronics in order to communicate effectively with environmental chamber and monitoring equipment maintenance and metrology personnel.
- Knowledge of CFR 21Part 11.
- Demonstrate the ability to identify problems, understand potential sources of error, and perform troubleshooting where necessary.
- Must have excellent communication skills (verbal and written). Highly organized with a strong attention to detail, clarity, accuracy and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).