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17 days old

Downstream Manufacturing Supervisor - El Segundo, CA

Kelly Services
El Segundo, CA 90245
**Downstream Manufacturing Supervisor - El Segundo, CA**



**Job Description:**



The Downstream Manufacturing Supervisor will be responsible for supervision of all downstream Purification day-to-day floor manufacturing operations as well as all preparation activities on and off the manufacturing floor. The candidate will also participate in cross-functional projects with Product Development (PD) and Process Engineering (PE) to develop, scale up and transfer new products.


**DUTIES AND RESPONSBILITIES:**




+ Performs manufacturing activities according to Current Good Manufacturing Practices (cGMP) guidelines, including batch record execution, product and equipment changeover, manufacturing equipment troubleshooting, and issue resolution.

+ Execute process operations in accordance to dynamic production timeline.

+ Develop or assist in developing a Purification operational schedule based on complete adherence to organizational time-lines.

+ Ensures safety and cGMP compliance in manufacturing area at all times.

+ Communicate transparently with management.

+ Ensure staff is trained and proficient to perform all aspects of Purification operations in accordance with cGMPs.

+ Develop and author necessary supporting cGMP documentation that supports all Purification manufacturing processes.

+ Author CAPA reports and drive implementation of actions according to the mandated timelines agreed upon in conjunction with the Quality Assurance group.

+ Successfully maintain aseptic gowning qualification status and participate in annual media fills.

+ Attend and drive value added meetings as necessary.

+ Mentor, train and develop Manufacturing Associates.

+ Cross-train on and assist with Upstream operations as required.

+ Effectively engage cross-functionally with other departments in order to stream-line all operations supporting cGMP manufacturing.

+ Communicate and facilitate effectively with external groups as applicable to support team success.

+ Develop and contribute process improvement initiatives with all Purification manufacturing equipment and operations.

+ Assist or execute ordering of material and ensure that equipment and materials are available for production runs.

+ Assist with On-The-Job (OJT) training of new Purification manufacturing operators.

+ Maintain current on all cGMP requirements.

+ Maintain and sustain all organizational training profile requirements.




**REQUIRED COMPETENCIES (KNOWLEDGE, SKILLS AND EXPERIENCE):**




+ MS with 2-5 years, or BS with 5-8 years of cGMP Biopharmaceutical manufacturing industry experience in multi-product facilities.

+ Prior experience in manufacturing is required.

+ Prior hands-on experience with chromatography systems, such as AKTA process skids, is required.

+ Experience in clinical and/or commercial scale production operations subject to cGMP regulations.

+ Strong interpersonal skills, a collaborator and team player, inclusive to the diverse opinions of others.

+ Fluency with MS Office (Word/Excel/PowerPoint/Project/Visio/OneNote).

+ Excellent oral and written communication skills.

+ Must be a self-starter and highly motivated.

+ Ability to multitask projects simultaneously, and prioritize projects.

+ Must have ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC).

+ Ability to work weekends occasionally to support the dynamic production schedule and relevant time-lines.

+ Ability to occasionally work extended shift hours to support the dynamic production schedule and relevant time-lines.

+ Must have the ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate clean room gowning material and appropriate personal protective equipment is required.



**_For immediate consideration apply today!_**



**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**




**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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2021-01-06 Expires: 2021-02-06

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Downstream Manufacturing Supervisor - El Segundo, CA

Kelly Services
El Segundo, CA 90245

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