11 days old

GMP Biologics Supervisor (Downstream) - Irvine area, CA

Kelly Services
Tustin, CA 92781
**Downstream Biomanufacturing Supervisor, Irvine area, CA**

**Position Summary/Objective:** The Downstream Biomanufacturing Supervisor is responsible for the supervision of Downstream manufacturing staff and operations for mammalian cell culture, as well as regularly performing hands on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.

**Schedule/Shift:** Flexible schedule due to operations/scheduling. Work overtime and weekends as required. Perform shift work Sun-Wed or Wed-Sat, 4 day x 10 hours

**Essential Duties and Responsibilities:**

+ Schedule, plan and coordinate production activities for large scale cell culture.

+ Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required.

+ cGMP documentation.

+ Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).

+ Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.

+ Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.

+ Coordinate manufacturing, validation, and maintenance activities with supporting departments.

+ Oversee the setup of new manufacturing processes and critical equipment.

+ Identify the technical, procedural and equipment issues that hinder production and compliance.

+ Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.

+ Assist in the transfer of technology from Process Development to GMP Manufacturing.

+ Assist with technical and compliance investigations, inspections and audits.

+ Report all unsafe activities to department manager, EHS and/or Human Resources.

+ Participate in proactive team efforts to achieve departmental and company goals.

+ Manage direct reports and escalate issues to manager as needed.

**Job Requirements:**

+ Science-related, Bachelor's degree (BS) or equivalent from four-year college or university plus three (3) years related experience and/or training; or equivalent combination of education and experience.

+ Mammalian CHO Cell Manufacturing Experience in a GMP Biologics Environment.

****Potential bonuses and relocation assistance offered.**

**For immediate consideration apply today!**

**Questions? Please reach out to Dustin at**

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-02-15 Expires: 2021-03-18

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

GMP Biologics Supervisor (Downstream) - Irvine area, CA

Kelly Services
Tustin, CA 92781

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast