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Senior Scientist

11 hours ago

Fremont, California, United States Buckeye Global Full time

Job Title: Scientist III (Senior Scientist)

Job Duration: 6+ Months Contract – W2

Job Location: Alameda California Onsite)

Note:

Must Have:

  • AKTA (Chromatography Technology)
  • Antibody Purification
  • Downstream Process Development
  • High-Performance Liquid Chromatography (HPLC)
  • Protein Purification
  • Tangential Flow Filtration (TFF)
  • AEX (Anion Exchange Chromatography), IEX (Cation Exchange Chromatography)
  • Protein A

Job Summary:

Scientist III, Biologics Downstream Process Development
will independently conduct laboratory experiments with limited supervision to develop purification processes and support technology transfer and manufacturing of biological drug candidates.

Essential Duties and Responsibilities:

  • Under minimial 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.

Education/Experience/Knowledge & Skills:

Education/Experience:

  • 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/The Ideal for Successful Entry into Job:

  • 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

Knowledge/Skills:

  • 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