14 days old

Scientist – Analytical Development and Manufacturing

Object Pharma, Inc.
Madison, Wisconsin 53719
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

Object Pharma is a biotech company located in Aliso Viejo, California, with GMP facilities in Madison, Wisconsin. Object is developing novel neurotoxin products for aesthetic and therapeutic applications. We offer our employees competitive compensation, a flexible, fast-paced environment, and the opportunity to learn a diverse skill set in an expanding company.

We are an equal opportunity employer.

The Company: Object Pharma owns Clostridium botulinum serotypes A through G and has a pipeline of neurotoxin candidates that will expand the clinical application of neurotoxins.

  • Our employees have the unique opportunity to develop broad expertise in a small, inclusive company.
  • We believe that every member is critical to building a strong company and generating superior products.

The Position: We are looking for a Scientist with experience in analytical method development for protein therapeutics to join a group responsible for process development and GMP manufacturing of clinical protein drug substance and product for use in clinical trials. The candidate will use a diverse set of skills to perform analytical development work, GMP manufacturing of DS (upstream and downstream) and aseptic DP manufacturing.

Responsibilities:

  • Develop, implement, and run analytical methods for protein characterization and testing.
  • Identify, develop, and implement analytical methods for drug substance and product to meet requirements for in-process testing and release of GMP material.
  • Work with a team of multiskilled researchers to develop and produce drug substance and drug product for therapeutic use working in a BSL 2 or 3 enhanced environment.
  • Develop and execute protocols for purification of proteins from conditioned media or extracts of microbial extracts.
  • Perform, develop, and implement protocols for microbial processes.
  • Perform work in Biological Safety Level (BSL) 2 and 3 environments
  • Work with other team members to implement requirements and documentation to meet cGMP standards.
  • Train team members on analytical methods and GMP requirements for test methods.
  • Develop and implement documentations such as batch records, protocols, scientific reports, and SOP’s.
  • Crosstrain in relevant areas and train other laboratory members in various tasks
  • Team player capable of working closely with people across disciplines to troubleshoot scientific work.
  • Perform other tasks as assigned from time to time.
  • Identify and implement new technologies for development and manufacturing of therapeutics.

Requirements:

  • A Ph.D. in Biochemistry, Microbiology, Molecular Biology, Biochemical engineering, or a relevant field with 5 years of experience in analytical development in a process development and GMP manufacturing environment.
  • Ability to work with a talented team of professionals to implement company and project goals.
  • Hands-on experience in the purification of proteins from microbial cultures.
  • Hands-on experience with chromatography techniques, including HPLC and FPLC, and various other chromatography methods such as reverse phase, ion exchange and hydrophobic interaction chromatography.
  • Experience with separation methods used in protein purification, such as filtration, concentration, and precipitation.
  • Experience with and knowledge of current protein detection and characterization techniques like SDS-PAGE, ELISA, mass spectrometry, UV, visible and fluorescence spectrophotometry, capillary electrophoresis, and chromatography methods.
  • Experience in writing SOP’s, batch records, research reports, data analysis, investigation reports (CAPA).
  • Team player with demonstrated willingness to learn new skills across relevant specialties to fit the broad needs of a small biotechnology company.
  • Physical ability to work regularly in a laboratory environment, including walking/standing for long periods of time, using standard laboratory equipment, using standard office equipment, and occasionally lifting up to 40 pounds.
  • Employees must pass a background check and receive CDC approval to work with Select Agents and toxins. Previous CDC approval is an advantage.

The Location: This position is located at Object Pharma in Madison, Wisconsin.

Equal Employment Opportunity


Object Pharma is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to any legally protected characteristic in compliance with U.S. and State of Wisconsin employment laws.

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Posted: 2020-07-20 Expires: 2020-08-19

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Scientist – Analytical Development and Manufacturing

Object Pharma, Inc.
Madison, Wisconsin 53719

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