Upstream Principal Scientist
4560 Horton Street Bldg. R-431 Emeryville, CA 94608
Bayside Solutions is seeking an Upstream Principal Scientist to be part of our client’ s team in Emeryville. 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.
Upstream Principal Scientist:
- 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:
- Knowledge in area of protein & monoclonal antibodies production using mammalian host cell systems, experience with microbial based host cell systems for recombinant protein production is a plus.
- Responsible for design & execution of experiments regarding cell culture media screening/development, evaluate feeding strategies, process parameter optimization & scale-up to support large scale production.
- Candidate will monitor, explore & evaluate next generation technologies to speed up process development.
- Be responsible for technology transfer to third parties including partners & CMO.
- Supports process technology transfer & scale-up to commercial facilities.
- Individual will be accountable for scientific data review including data integrity verification, statistical analysis & technical report writing.
- Directly interfaces with other departmental groups (R&D, Quality Assurance, Regulatory Affairs, Supply Chain & Manufacturing).
- Provide technical leadership to staff with focus on verbal & written communications, teamwork & problem solving.
- Direct interaction & effective collaboration with other team members.
- Strong ability to set & meet deadlines & multitask based on project needs.
- Uses scientific knowledge to make decisions on projects.
- Analyzes data & results and makes recommendations that impact both the science & the business.
- Demonstrates critical judgment & strategic thinking to represent functional area concerns on cross-functional teams.
- Participates in cross-functional initiatives to advance & enable Grifols long term goals.
- Ensures safe working practices are followed in laboratories & pilot plants.
Summary of Qualifications:
- Master’ s or PhD in science or engineering preferred.
- Minimum of 10 yrs. experience in product development, manufacturing science & technology, process engineering within the pharmaceutical industry required.
- 7 yrs. experience working in a pharmaceutical manufacturing site.
- Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements.
- Technical/scientific knowledge of biopharmaceutical processes, both process development & manufacturing scales of operation
- Knowledge of process scale-up & scale-down methodologies, including process characterization & design of experiments
- Understanding/experience with wave bag systems & SUBs is essential.
- Familiarity with Finesse Delta V control systems & PI systems is highly desirable.
- Experience in process technology transfer within & between organizations, manufacturing support & troubleshooting
- Demonstrated teamwork, organizational & leadership skills
- Writes procedures & technical reports that include data interpretation.
- Extensive working knowledge of cGMP environments
- Attention to detail, strong organizational skills, ability to multitask, effective interpersonal & communication skills are required.
- Can identify & request needed resources within or across functional areas.
- Must have advanced written & oral communication skills.
- Independently applies sound scientific principles in development of innovative solutions to complex technical problems.
- Skilled in application of standardized root cause analysis, investigation tools & methodologies.
- Proficient with the use of MS Office (Excel, Word, PowerPoint), application software including Unicorn, JMP, Minitab, Design Expert, etc.