300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a Manufacturing Associate to be part of our client’ s team in the North 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.
- 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:
- Understanding of process theory and equipment operation
- Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
- Support initiatives for process optimization
- Identify and elevate processing issues and support solutions
- Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.)
- Provide feedback and/or suggested changes to operational procedures
- Assist in the incorporation of new technologies, practices and standards into procedures
- Capable of writing and reviewing process documents
- Understanding of cGMPs as related to Commercial Operations
- Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.
- Ability to participate on projects and contribute to outcomes
- Capability to learn and support new business systems (Track wise, ERP, etc.)
- Support trending of defined department metrics
Summary of Qualifications:
- Bachelor’ s degree in science related area or engineering or Associate’ s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
- Operate large scale bioprocess equipment for the cell culture and purification processing
- Perform all aspects of processing with a broad understanding of science, compliance and technical aspect
- Display competency with process equipment and automated control systems
- Perform cleaning and sterilization of parts and equipment used with manufacturing process
- Broad knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation
- Ability to understand, apply, and evaluate basic chemistry, biology and scientific principles as appropriate for the position
- Proficiency with compliance; adherence to standard operating procedures, batch record, good documentation practices and data capturing