Manager, Analytical Services
- 10 Finderne Ave, Bridgewater, NJ 08807, USA
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.
This position reports to the Associate Director of Analytical Services and is located at the Insmed Corporate Headquarters located in Bridgewater, New Jersey.
- Upholds the operations area to highest standards of quality, safety, and security
- Oversees testing being performed by contract laboratory(s) to ensure testing is completed within the contracted time frame, all investigations are properly closed out, and communicates delays to management and to the manufacturing sites
- Ensures stability samples are pulled and tested within the applicable time frame
- Compiles data received from contract laboratory, reviews, trends, and uploads data to Electronic Data Management System(s)
- Alerts Management of any out of trend or out of specification data immediately upon discovery
- Point person for stability software and LIMS (Laboratory Information Management System) / IT Systems. Works with IT staff, acts as subject matter expert and supports change control, as needed
- Stability software and LIMS user and eventual subject matter expert for the group
- Authors user requirements and manages new software version testing for release and stability trending
- Tracks Product programs schedule vs. Actual Timing
- Responsible for Stability Program status (study starts, workload distribution, metrics, etc).
- Monitors delivery of approved results in accordance with Quality Service Agreements
- Develops and manages continuous improvement projects
- Conducts problem solving and troubleshooting to resolve issues related to Operations, Quality, or LIMS
- Assists with quality investigations and implementation of CAPAs (Corrective and Preventative Actions) with the Quality Assurance Department
- Manages procedural document creation and revisions when required
- B.S. degree in the Life Sciences (Biology, Chemistry, Pharmacy), Engineering, or in a related science area, with a minimum of five (5) years of experience in the pharmaceutical industry.
- Broad experience and depth of knowledge in pharmaceutical quality control and stability operations, quality systems and LIMS operation. Statistical evaluation of data is a plus.
- The successful candidate will be a self-starter and have demonstrated ability to make decisions independently.
- 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
- Basic understanding of mechanical systems and electronics in order to communicate effectively with environmental chamber and monitoring equipment maintenance and metrology personnel
- Working knowledge of CFR 21Part 11
- Should demonstrate the ability to identify problems, understand potential sources of error, and perform troubleshooting where necessary
- Excellent communication skills (verbal and written).
- Highly organized with strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe.
All your information will be kept confidential according to EEO guidelines.