Ultimate Staffing · 22 hours ago
Scientist III
Oakland, CA
Contract
Onsite
Entry, Mid Level
$55/hr - $69.70/hr
1+ years expUltimate Staffing is seeking a Scientist III for Biologics Downstream Process Development. The role involves conducting laboratory experiments to develop purification processes and support the manufacturing of biological drug candidates, requiring strong technical expertise in downstream process development.
EmploymentHuman ResourcesManufacturingStaffing Agency
Hiring Manager
Brianna Zhong
Responsibilities
Under minimal supervision, develop and execute laboratory studies in downstream process development (chromatography purification, viral filtration, TFF, etc) to support unit operation scale up and technology transfers to enable clinical production
Undertake production campaigns from Lab - Pilot Scale
Collaborate with internal and external partners in upstream process development, analytical development, and formulation development groups to advance CMC biologics programs
Maintain complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training
Provide detailed reviews of peer generated data as well as that generated from contracted service providers
Maintain the inventory of laboratory consumables and clean glassware
Coordinate vendors service calls for repair and maintenance of laboratory instruments, perform routine maintenance of laboratory instrumentation, and maintain complete and accurate records of instrument service and repairs in conformance with company SOPs and policies
Work to establish, maintain, and lead internal downstream process development and scale up lab capabilities at Exelixis in CMC Biologics
Qualification
Required
Bachelor's degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of three (3) years of relevant drug discovery/development experience; or
Master's degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of one (1) year of relevant drug discovery/development experience; or
Equivalent combination of education and experience
Experience applying their technical knowledge to drive critical objectives for CMC biologics across the product life cycle
Hands-on experience in recombinant protein purification and downstream process development
Familiarity with harvest and clarification unit operations
Hands-on experience with Fast Protein Liquid Chromatography (FPLC) systems (e.g. Akta Avant, Akta Pilot, Akta Ready, etc) for chromatography-based purification development
Experience developing scalable chromatography purification unit operations (Affinity, IEX, HIC, SEC, mixed mode, etc)
Experience developing scalable viral filtration and TFF unit operations
Working knowledge of CMC upstream process development, analytical development, formulation development, bioconjugation process development, technology transfer, and GMP quality requirements
Ability to run basic analytical purity assays (SEC-HPLC) and in-process impurity clearance assays (HCP, res DNA, res ProA) independently
Demonstrated capability to work independently on complex technical problems, effectively in cross-functional teams, and with external CDMOs and partners
Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives
Expertise in downstream (purification) process development
Broad and deep knowledge of CMC biologics downstream processes
Working knowledge of upstream process development, analytics, formulation development, and bioconjugation process development
Ability to apply technical knowledge to CMC development and manufacturing for biologics across the product life cycle
Ability to multi-task in a fast-paced dynamic environment while delivering high quality work
Strong understanding of cGMP quality and regulatory requirements for CMC biologics
Sets goals with understanding of priority and impact to the program, department, and organization
Excellent interpersonal, presentation, and written communication skills
Excellent organizational and documentation skills and habits
Creative thinker and complex problem solver
Preferred
Experience developing scalable chromatography purification unit operations (Affinity, IEX, HIC, SEC, mixed mode, etc)
Experience developing scalable viral filtration and TFF unit operations
Company
Ultimate Staffing
Ultimate Staffing specializes in clerical, administrative, customer service, and manufacturing and production positions.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Lisa Marez
Partnership Director
Company data provided by crunchbase