Manager, Analytical Services | BioNJ Talent Services

Manager, Analytical Services

Contact Information
Contact Name: 
Insmed
Organization Name: 
Insmed
Position Location: 
Bridgewater
Company Profile: 

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.

Job Description:

This position will provide analytical supervision and support for all development projects; manage external vendors, make recommendations to senior management and contribute to regulatory documents from an analytical perspective.

This position reports to the Director of CMC Development and is located at the Insmed Corporate Headquarters located in Bridgewater, New Jersey.

Responsibilities

· Manage and oversee external vendors, serving as primary contact for all activities related to raw materials, in-process, DS/DP lot release testing, analytical method transfers and analytical method validation.

· Manage and oversee the stability program for all Insmed’s development programs and apply statistical analysis for interpretation of analytical and stability data. Serves as point person for stability software and LIMS (Laboratory Information Management System) / IT Systems.

· Author and/or review the development, qualification, validation and transfer of documents.

· Support manufacturing investigations. Participate in review and peer proofing activities within and between departments.

· Lead incident/OOS investigations ensuring that the investigation is thorough and completed in a timely manner. Interact with QA to ensure closure of compliance gaps.

· Contribute to documents for regulatory filings.

Qualifications: 

· B.S. degree in the Life Sciences (Biology, Chemistry, Pharmacy), Engineering, or in a related science area, with a minimum of eight (8) years of experience in the pharmaceutical industry working in a CMC and GMP/GLP laboratory setting.

· 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.

· Strong organizational/follow-up and planning skills

· Good interpersonal and communication skills (verbal and written)

· An understanding and knowledge of quality systems, documentation practices, and equipment IQ/OQ/PQ in a cGMP regulated environment is required

· 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

· Ability to identify problems, understand potential sources of error, and perform troubleshooting where necessary

· Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Other