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Upstream Principal Scientist - Biopharmaceuticals
Emeryville, CA 94608
Our client is seeking a highly motivated and innovative Upstream Principal Scientist to join the Manufacturing Sciences and Technology group. The successful candidate will provide technical or scientific expertise and leadership in the upstream process development of mammalian cell culture derived recombinant proteins and monoclonal antibodies. In addition to upstream process development the candidate will lead the efforts for developing and optimizing cell culture processes including process parameter optimization, process characterization and scale-up/tech transfer for large scale product production. As a plus the candidate will also have experience with microbial fermentation based processes and associated process development, technical transfer and support successful implementation of production fermentation processes at commercial scale.
PRIMARY RESPONSIBILITIES FOR ROLE
- Has considerable knowledge in area of protein and monoclonal antibodies production using mammalian host cell systems, experience with microbial based host cell systems for recombinant protein production is a plus.
- Responsible for the design and execution of experiments with regards to cell culture media screening/development, evaluate feeding strategies, process parameter optimization, and scale-up to support large scale production
- The candidate will monitor, explore and evaluate next generation technologies to speed up process development. This individual will also be responsible for technology transfer to third parties including partners and CMO
- Supports process technology transfer and scale-up to commercial facilities
- The individual will be accountable for scientific data review including data integrity verification, statistical analysis and technical report writing.
- Directly interfaces with other departmental groups such as R&D, Quality Assurance, Regulatory Affairs, Supply Chain and Manufacturing
- Provide technical leadership to staff with focus on verbal and written communications, teamwork, and problem solving
- Direct interaction and effective collaboration with other team members
- Strong ability to set and meet deadlines and multitask based on project needs.
- Uses scientific knowledge to make decisions on projects. Analyzes data and results and makes recommendations that impact both the science and the business
- Demonstrates critical judgment and strategic thinking sufficient to represent functional area concerns on cross-functional teams.
- Participates in cross-functional initiatives to advance and enable long term goals
- Ensures that safe working practices are followed in laboratories and pilot plants
KNOWLEDGE, SKILLS, AND ABILITIES
- Technical/scientific knowledge of biopharmaceutical processes, at both process development and manufacturing scales of operation
- Knowledge of process scale-up and scale-down methodologies, including process characterization and design of experiments
- Understanding/experience with wave bag systems and SUBs is essential.
- Familiarity with Finesse Delta V control systems and PI systems is highly desirable.
- Experience in process technology transfer within and between organizations, manufacturing support and troubleshooting
- Demonstrated teamwork, organizational, and leadership skills
- Writes procedures and technical reports that include data interpretation.
- Extensive working knowledge of cGMP environments
- Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
- Can identify and request needed resources within or across functional areas.
- Must have advanced written and 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 and methodologies.
- Proficient with the use of MS Office software(MS Excel, MS Word, MSPowerpoint) and application software including Unicorn,JMP,Minitab, Design Expert etc).
- Master’s or PhD degree in science or engineering preferred
- Minimum of 10 years of experience in product development, manufacturing science and technology, process engineering within the pharmaceutical industry required
- 7 years of experience working in a pharmaceutical manufacturing site
- Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements
- Excellent communication skills and attention to details