Manufacturing Associate I, Purification - 1st Shift

Fremont, CA 94555

Posted: 08/17/2020 Employment Type: Contract Industry: Clinical & Scientific Job Number: 17797

Job Description


Bayside Solutions is seeking a Manufacturing Associate I, Purification - 1st Shift to be part of our client’ s team in the East Bay. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.

Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

Manufacturing Associate I, Purification - 3rd Shift

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.  
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.

Summary of Responsibilities:
  • Executes routine unit operations in Cell Culture /Purification such as bioreactor inoculation, cell separation, chromatography and tangential flow filtration as well as Clean-In-Place (CIP) and Steam-In-Place (SIP) operations.
  • Practices ergonomic safety and use appropriate personal protective equipment (PPE) in all operations.
  • Performs in-process analytical instrument measurements of e.g. pH, cell viability and viable cell density, osmolality, gas content, metabolites, spectrophotometry, or conductivity.
  • Documents execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP).
  • Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
  • Reports any issues related to manufacturing performance, process and safety to the team lead or Manager in order to ensure safety and compliance with regulations and cGMPs and to facilitate continuous process improvement.
  • Adherence to GMP training schedule and responsible for achieving all training requirements within acceptable timelines.
  • Performs routine housekeeping of the manufacturing plant using the 5S organization methodology by using appropriate equipment safety signage, labeling of parts-in-process, sweeping water pools to the floor drain, and picking up parts from the floor.
  • Unit operations described in standard operating procedures and batch records.
  • Recognizes and corrects errors in bioprocess operations prior to failure.
  • Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.
  • Performs review of GMP documentation.
  • Completes required processing documentation including, product change over and other documentation.
  • Reviews and signs executed process and solution MBRs.
  • Ensures acceptable quality and quantity of work executed.
  • Ensures that standard operating procedures (SOPs) are followed and are correct for bioprocess operations and equipment.
  • Ensures compliance with company quality systems, safety procedures, and other company policies.
  • Judgment required to apply industry practices and company policies to daily operations.

Required Qualifications:
  • Requires a High School Diploma or equivalent plus four (4) years closely related technical experience, preferably in a pharmaceutical or chemicals manufacturing environment. An Associate’ s Degree with a minimum of two (2) years closely related technical experience, preferably in a pharmaceutical or chemicals manufacturing environment; or a Bachelors’ degree, preferably in a science or engineering field is preferred with 1+ years of GMP exp.
  • Experiences in related biotechnology/pharmaceutical industry strongly preferred
  • Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer-based software
  • Preferred skills include experience in: Current Good Manufacturing Practices, Mammalian cell culture, Bio Manufacturing Execution System (BioMES), Process Control System DeltaV, Laboratory Management Information System (LIMS)
  • Experience working with established GMP procedures and bulk manufacturing.
  • Technical knowledge of manufacturing systems, methods and procedures.
  • Understanding of purification/cell culture processes.
  • Possess effective troubleshooting.
  • Experience working with established GMP procedures and bulk manufacturing.
  • Technical knowledge of manufacturing systems, methods and procedures.
  • Understanding of cell culture processes.
  • Possess effective troubleshooting skills with equipment and/or process.
  • Demonstrated ability to be organized and work well in small work groups.
  • Be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
  • Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
  • Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
  • Demonstrated written and verbal communication skills are required.
  • Must be able to work in a team environment.

Meet Your Recruiter

Allison Glogovac

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