Manufacturing Associate III & IV

　　Downstream/Upstream

　　Kelly Science & Clinical is currently recruiting for a Manufacturing Associate III & IV, Downstream/Upstream for a contract research, development, and biomanufacturing company.

　　Job Responsibilities:

　　Supports daily manufacturing responsibilities for clinical and commercial manufacturing programs.

　　Executes and documents batch records in compliance with current Good Documentation Practices.

　　Revise and review SOPs, batch records, and other documentation to support manufacturing.

　　Microbial fermentation and/or Mammalian cell culture in Upstream/Downstream processing.

　　Support deviation and CAPA resolution with SME and quality teams.

　　Provide input and support to MSAT/PD during development and scale up activities as necessary.

　　Support facilities in ensuring proper functionality of the equipment calibration and preventative maintenance as part of the equipment control program.

　　Job Qualifications:

　　Requires an Associate’s, BS or MS from an accredited college or university with major coursework in a Scientific or Engineering discipline.

　　Experience working in a GMP manufacturing environment is essential.

　　Manufacturing processes in microbial systems is highly desirable.

　　Requires 2+ year (Associate’s), 3+ years (BS), 1+ years (MS) of biomanufacturing experience.

　　Requires a strong background in cGMP principles and Quality Management Systems.

　　Downstream knowledge and experience with the following:

　　Bench-scale to Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration

　　Bench-scale to Large-scale Chromatographic (AKTA) and HPLC systems (Agilent)

　　Packing and evaluating columns

　　Drug Substance Bulk fill or vial fill and aseptic handling techniques

　　Upstream knowledge and experience with the following:

　　Bacterial fermentation and Mammalian single-use systems up to 1000L

　　Continuous flow centrifuges

　　Homogenization and depth filtration operations

　　Single-Use temperature controlled mixing systems

　　Job Details:

　　Monday-Friday; Day Shift; Flexible to work overtime

　　Mammalian and Microbial experience preferred

　　Direct Hire; Full-Line of Benefits

　　For immediate consideration, please forward your updated resume to [email protected].

　　As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Science & Clinical?

　　Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.