Manufacturing Bioprocess Technician
44 DNA Way, SSF03 South San Francisco, CA 94080
Bayside Solutions is seeking a Manufacturing Bioprocess Technician to be part of our client’ s team in South San Francisco. 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 Bioprocess Technician
- 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:
- Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Responsible for being proficient in one functional area. Understands and applies biological, chemical and mechanical principles and techniques.
- Operate systems that clean and sterilize tanks and filtration systems.
- Prepare solutions for the production process.
- Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
- Trouble shoot equipment and process problems.
- Comply with safety requirements, cGMP, SOP and manufacturing documentation.
- Use of automation to perform production operations.
- Provide support to Manufacturing to meet production demands.
- Operate automated systems for equipment operation.
- Assemble and prepare equipment for production.
- Exhibit detail oriented documentation skills
- Communicate effectively and ability to work in a team environment.
- Exhibit professional interpersonal skills.
- Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
- Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.
- Supplementary Responsibilities:
- Operate bioreactors, centrifuges, other harvest systems and protein purifications units.
- Operate and clean fixed tank and filtration systems
- Operate large scale column chromatography systems.
- Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
- Perform Solution Preparation activities (media and buffer make-up)
- Clean, assemble, and sterilize equipment using glass washers and autoclaves.
- Perform automated CIP and SIP of fixed equipment.
- Job Matrix
- A good working knowledge of biopharm technology and processes.
- Trained and skilled in all operational procedures of at least one manufacturing department.
- Demonstrated ability to independently document and record information related to the process.
- Occasionally makes routine decisions based on experience. Identifies and suggests solutions to common basic problems.
- Recognizes non-routine problems, investigates and suggests potential solutions.
- Judgment is required in resolving problems and making routine recommendations.
- Ability to recognize deviation from accepted practices is required.
Summary of Qualifications:
- Degree in Life Sciences or engineering and 1 year related experience
- Or Associate Degree and 3 year experience
- Or High school and 5 years’ experience
- Biotech certificate from approved program
- Strong oral and written communication skills.
- Familiarity of computer-based systems
- Background in fermentation
- Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
- Work Environment/Physical Demands/Safety Considerations
- Schedule could include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours.
- Expected to be on feet for 8 to 10 hours a day.
- Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
- Lift up to 25lbs may be required. Environment requires approved gowning based on QS38 standards, gloves and steel toe boots to be worn.
- No make up or jewelry can be worn when working in the clean room environment.
- Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
- Work with hazardous materials and chemicals.