Senior Manufacturing Associate
Principia Biopharma, Inc.
Position Overview/Department Description
Operates manufacturing processing equipment inside environmentally controlled areas in accordance to established SOP’s and safety regulations.
Documents production operations in corresponding batch records and log sheets according to cGMP's and established SOPs.
Performs routine cleaning procedures for equipment and the manufacturing-controlled area. Follow safety guidelines
Assists in Validation activities and process improvements.
Works independently with little supervision.
Interacts with support groups.
Trains new employees.
Works on deviations and CAPA’s
Authors and revises documents.
Maintains the production schedule based on the production plan.
Acts as supervisor and reports department metrics as needed.
Serves as a technical resource for troubleshooting activities. 3.0
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products. Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Bachelor’s Degree or 8 + years’ experience in a cGMP manufacturing environment.
Strong leadership skills.
Excellent documentation skills.
Works with a team of 10-12 Associates and Technicians to complete daily production schedule and manufacturing responsibilities.
Understanding of GXP and how it applies to specific responsibilities.
Excellent written and oral English language skills.
Technical writing skills.
Experience with Pheinix.
Experience operating in gowning and clean room environments.
Experience in troubles shooting investigation, and root cause analysis in a GXP environment.
Special Working Conditions:
Requires working with hazardous materials. Requires physical demands of lifting to 30 pounds.
Some weekends/holidays work required.
Overtime available to meet production demands.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.ID:uDnQdo