Danaher Corporation Senior Manufacturing Associate Upstream in Bothell, Washington
Job Title: Senior Manufacturing Associate Upstream
Job Location: Bothell
Date Written: May 6, 2021
Written By: Samuel Li
Job Profile (Level-Job Family): P2-Professional
Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer.
The successful applicant will work for the Department of Upstream Enzyme Manufacturing, with a focus delivering high quality microbial recombinant cell pastes to the downstream manufacturing group. The material is a key ingredient of our diagnostic kit production. He/She may also contribute to multiple phases of bioprocess development and production of enzymes and proteins. The position level depends on the experience and responsibilities.
ESSENTIAL JOB RESPONSIBILITIES:
Carry out upstream manufacturing processing including GMP production follow BPRs, bioreactor handling 10–50-liter scale, sampling, solution preparation, sterilization, harvesting. Perform process monitoring/trending evaluation and implement corrective and preventive actions when called upon. Actively collaborate with other functions such as Bioanalytical, QA and QC. Flexible with work hours. Team player.
Other responsibilities included but not limited to:
Collaborate with the upstream process development team to process batch production lots for development group to demonstrate reproducibility, as well as validate new candidate lines.
Embrace, evaluate and transfer new technologies from upstream process development group.
Maintain data record, and author/review SOPs, technical reports, manufacture documents, and document for process transfer.
Embrace our DBS Culture of constant improvement in the process and champion those processes.
Work with cross functional teams Quality, Facilities, Development, to optimize the protein engineering and production function.
TRAINING RESPONSIBILITIES: (REQUIRED)
Complete all assigned and required training satisfactorily and on time.
For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
Education and Experience (in years):
BS/MS in Biology/Biochemistry/bioengineering or related field.
4+ years (for BS) and >3+ years (for MS) of relevant industry experience in biologics development and/or manufacturing facility environment are minimal
Knowledge and skills:
Experience in cGMP facility.
Experience with microbial fermentation manufacturing, mammalian cell culture in bioreactors.
Familiarity in process scale-up, and process transfer.
Experience with equipment qualification (IQ/OQ/PQ) and experience in preventive maintenance program.
Excellent equipment and problem-solving skills are necessary.
Demonstrated ability to collaborate effectively on cross functional teams to achieve objectives.
Excellent communication, inter-personal and organizational skills are required.
Experience with CIP, SIP and SUBs.
- Must be able to lift 40 lbs.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid