Manufacturing Associate I
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a Manufacturing Associate I 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
- 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:
- Performs production processes for GMP manufacturing operations.
- Operates large-scale and small-scale bioprocess equipment for purification processing.
- Executes routine unit operations in Purification related to the manufacturing of bulk drug substance in a multi-product facility, as assigned. This may include tank CIP/SIP, transfer, harvest, chromatography, and tangential flow filtration. Performs duties under limited supervision and according to standard operating procedures and batch records.
- Executes routine unit operations in Purification such as chromatography, tangential flow filtration, Clean-In-Place (CIP), and Steam-In-Place (SIP) operations. Practices ergonomic safety and uses appropriate personal protective equipment (PPE) in all operations.
- Performs in-process analytical instrument measurements e.g. pH, conductivity, temperature, pressure, among others.
- 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.
- Escalates to the team lead or Manager any manufacturing performance, process, or safety issues to ensure safety, regulation compliance, 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 appropriate equipment safety signage, labeling of in-process parts & equipment, squeegeeing liquids to the floor drains, and picking up parts that have fallen on the floor.
- Performs unit operations described in standard operating procedures and batch records.
- Recognizes and proactively 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.
- Demonstrates good judgment in applying industry practices and company policies to daily operations.
- Performs other duties as assigned.
- The position will require shift-work; including weekends, off hours, holidays, and potentially being on-call, as needed.
- Bachelor’ s Degree, preferred.
- 1+ years of experience in a biotech manufacturing environment or other regulated cGMP manufacturing facility and a Bachelor’ s degree in science related area or engineering or Associate’ s degree in science related area or Biotech certificate or in lieu of Education requirements 3 years of experience in cGMP manufacturing environment.
- Competency with process equipment and automated control systems
- Working experience with GMP manufacturing regulations.
- Working knowledge of manufacturing equipment and technology
- Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation
- Experience in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
- Ability to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position.
- Communication abilities: to read, speak, and write legibly in English.
- Proficiency in computer skills, including work with spreadsheet programs (Excel) and word processing (Word).
- Effective time management skills.
- Detail orientation with the ability to complete written and verbally assigned tasks following specific instructions and procedures.
- Ability to interact constructively with peers and support groups.
- Organizational and communication skills necessary to ensure daily work plan is executed