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:
- Executes routine unit operations in Cell Culture, Cell Inoculum as assigned related to the manufacturing of bulk drug substance in a multi-product facility. This may include cell inoculation and transfer in shake flasks and wave bioreactors. Performs duties under limited supervision and according to standard operating and manufacturing procedures.
- Executes routine unit operations in Cell Culture such as Thaw, cell inoculation, cell separation and media batching.
- 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.
- Participates in training and development opportunities in order to gain an understanding of SOPs, GMPs, regulatory compliance requirements and departmental policies.
- 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.
- Collaborates within team and department in order to follow best practices and meet department goals.
- 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 experience
- 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.
- Must 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.