Fremont, CA | Contract
Bayside Solutions is seeking a Manufacturing Associate- 1st Shift to be part of our client’ s team in the East Bay. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
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- 1st Shift
- 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 such as bioreactor inoculation, cell separation, 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, 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.
- Bachelors Degree or > 1 years’ experience with a focus in Biopharmaceuticals
- 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 skills with equipment and/or process.