Associate Manufacturing Technical Specialist
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking an Associate Manufacturing Technical Specialist to be part of our client’ s team in Vacaville. 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.
Associate Manufacturing Technical Specialist:
- 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:
- Provide technical support and stewardship for cell culture operations of the process, which focuses on mammalian cell culture growth and production of drug substance.
- Play a key role during all aspects of the product lifecycle, from transfer into the manufacturing facility through commercialization and ongoing monitoring of operations, to ensure consistent process performance.
- Working with engineers and specialists to learn the science behind the cell culture operations of the manufacturing process.
- Responsible for writing protocols, executing studies (small scale and large scale), and writing reports to support process characterization and validation activities per Validation Project Plan and Tech Transfer Activities.
- Assisting in laboratory operations, including media and bioreactor preparation, maintaining analytical equipment and monitoring of cell culture step performance.
- Completing small scale experiments for scale down bioreactor operations.
- Responsible for coordinating technical meetings (ie. setting up the meetings, communicating agenda, and drafting minutes).
- Assist in review of User Requirement Specifications, Critically Assessments, System Impact Assessments, and Risk Assessments.
- Project debug and implementation support.
Summary of Qualifications:
- Bachelor’ s degree or higher degree at an accredited college or university.
- 0-3 years of experience in process validation and/or cell culture operations.
- Must possess good problem solving, interpersonal, communication, and team skills.
- Contractor must be a self-starter with a strong focus on quality, details, and results.