Manufacturing Associate II - Upstream, San Diego, CA

Manufacturing Associate II - Upstream, San Diego, CA

Essential Duties and Responsibilities:

  • Perform work in a cGMP manufacturing environment.
  • Operate in a Class 10,000 and Class 100,000 rooms.
  • Perform cell vial thaw and flask expansion inside a Bio-Safety Cabinet (BSC) as well as generating Cell Banks for clients.
  • Operate and maintain equipment designed for single-use technology as it relates to cell culture such as the GE RTP WAVE 25 and Sartorius STR Systems (50 L to 2000 L).
  • Conduct activities in support of production schedules as directed by senior staff.
  • Obtain and stock supplies as directed.
  • Prepare media supplementation and salt solutions for cell culture production.
  • Maintain GMP records to comply with regulatory requirements and assist with in-process testing.
  • Work is closely supervised, until fully trained in GMP procedures.
  • Revise and review SOPs, master batch records, specifications, and other applicable cGMP documentation for Manufacturing.
  • Support multiple projects simultaneously.
  • Initiate deviations as required during GMP process execution.
  • Perform manufacturing and process development activities for projects and products in collaboration with others.
  • May provide training to new personnel for Upstream technical processes and equipment.
  • May cross-train on various tasks including Downstream cGMP manufacturing and PD processes as needed to support overall success of the Biologics group.
  • Review completed batch records daily for GMP compliance and completeness.

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with company's policies and procedures.
  • Adheres to quality standards set by regulations and company policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of company¿s business.
  • Travels as needed to attend professional conferences, train on new technologies or travel between GMP facilities.
  • Work requires occasional days of more than the standard eight-hour shift, and weekend duty.

Job Requirements:

  • Minimum Associate's (AS) degree that that included laboratory work in a Chemistry, Biology, Chemical Engineering or related field.
  • Bachelor's degree (BA / BS) in Chemistry, Biology, Chemical Engineering or related field, preferred.
  • Minimum 2 to 4 years of experience in a GMP pharmaceutical or biotech environment.
  • Skill with aseptic handling required, including BSC operations to maintain the integrity of open cell culture operations.
  • Knowledge of mammalian cell culture processes.
  • Knowledge and understanding of cGMPs and how they apply to duties and responsibilities.
  • Skilled with using single-use technologies, including tube welding, tube sealing, and disposable systems
  • Ability to follow detailed instructions and to maintain accurate records.
  • Ability to effectively communicate status of floor operations to leads and senior staff.
  • Able to efficiently track and operate multiple projects, and multitask when required.
  • Ability to safely operate production equipment in accordance with established practices.

For immediate consideration, apply today!  Questions?  Call Jason at 714.971.0721

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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