Manufacturing Associate I (Downstream Purification)
35 Leveroni Ct Novato, CA 94949
Bayside Solutions is seeking a Manufacturing Associate I to be part of our client’ s team in Novato. 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 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:
- PROCESS KNOWLEDGE:
- 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.)
- TECHNICAL DOCUMENTATION:
- 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
- QUALITY AND COMPLIANCE:
- 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
- WORK ENVIRONMENT/PHYSICAL DEMANDS:
- Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
- Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
- May require work around loud equipment.
- The use of personal protective equipment will be required.
- Requires various shift based work and off hours
Summary of Qualifications:
- Bachelor’ s degree in science related area or engineering
- Associate’ s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
- Strong communication skills— verbal and written
- Ability to work in a team environment which includes good conflict resolution and collaboration
- Displays good initiative to identify areas for improvement and implement solutions