Senior Scientist, Biologics (Cell based Assay)

Confidential Company  •  Kansas City, KS

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 08/04/17 by Lisa Gabor
Kansas City, KS
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 08/04/17 by Lisa Gabor

Senior Scientist, Biologics (Cell based Assay)

In support of large molecule therapeutics, develop and execute laboratory work plans/schedules for self and junior members of team, using customer milestones and Division/site performance standards and metrics. Sample types include in-process, release or stability.  Techniques may include any or all of the following:

  • Mammalian cell culture
  • Sterile technique
  • In vitro cell based assays (e.g. reporter gene bioassay, cell titer glo proliferation bioassay, etc.)
  • ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD)
  • Molecular biology (e.g. qPCR, PCR, etc.)
  • Kinetic binding assessment (e.g. BLI or SPR)
  • Flow cytometry
  • Othertechnologies/methodologies as required by management

In support of large molecule therapeutics, perform and/or guide method validation or transfer activities.  Perform and/or guide method development activities

  • Perform activities under cGMP as appropriate.
  • Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures.
  • Review technical documents for accuracy, thoroughness and regulatory compliance
  • Trains, coaches or mentors others on technical, personal development or business issues
  • Supervises technical staff, including work assignments and performance and development management
  • Responsible as project technical lead on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business
  • Drives improvement projects at the department level.  Identifies opportunities for improvement projects.
  • Support development of business strategies across the business units.
  • All other duties as assigned.

Qualifications:

Bachelor's degree with >10 years related experience, or equivalent education, experience and training; Master's degree with >8years related experience; Doctorate Degree with >4 years related experience.

Experience:

  • Good project management/coordination skills; Scientific background in GMP analytical and/or business background desirable; experience with S&OP; Good organizational skills; Significant experience with excel and PowerPoint.
  • Actual position will be commensurate with experience
  • Advanced project management skills are routinely practiced for multiple concurrent projects of moderate complexity
  • Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
  • Ability to learn and retain technical information
  • Advanced project management skills are routinely practiced for multiple concurrent projects of moderate complexity
  • Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones
  • Has substantial breadth/depth of technical acumen in multiple techniques and can understand their application in context of pharmaceutical services offerings
  • Can provide reliable/defendable interpretations of regulatory guidance’s for the customer
  • Mathematical and scientific reasoning ability
  • Capable of rapid learning of unfamiliar principles or techniques with minimum training
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  • Ability to work effectively under pressure to meet deadlines
  • Well organized with ability to handle multiple activities simultaneously
  • Excellent written and verbal communications skills with internal and external customers
  • Ability to communicate moderately complex technical information to non-technical audiences
  • Leadership development/ supervisory skills are expected.
  • Recommends and assists in implementation of new technologies and understands their impact on company offerings
  • High personal credibility with peers and subordinates
  • Excellent motivator, well versed in team development
  • Lead by example according to company values and culture
  • Can assess training needs and formulate development plans for direct reports
  • Based on broad technical skills and drug development experience, anticipates and identifies unmet customer needs
  • Ability to interpret, provide and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups
  • Understands the details of regulatory CMC filing package and the analytical documentation required therein
  • Ability to work effectively under pressure to meet deadlines
  • May publish or present externally

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