Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 2/7/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Upstream Principal Scientist – MS&T
Location: Emeryville, CA
Employment Type: Full Time, Contract
Pay Range: Open
Duration: 1 Year
Upstream Principal Scientist -MS&T - Manufacturing Sciences and Technology
Successful candidate will provide technical or scientific expertise & leadership in the upstream process development of mammalian cell culture derived recombinant proteins & monoclonal antibodies.
In addition to upstream process development candidate will lead efforts for developing & optimizing cell culture processes including process parameter optimization, process characterization & scale-up/tech transfer for large scale product production.
Candidate will also have experience with microbial fermentation-based processes & associated process development, technical transfer & support successful implementation of production fermentation processes at commercial scale.
Has considerable 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)
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.
Education: 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
Skills and Experience:
ROOT CAUSE ANALYSIS
TECHNICAL REPORT WRITING
MAMMALIAN CELL CULTURE
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776