Process Development Scientist II

2019 PD001

Job Description

Reporting to the VP of Operations, this position will be responsible for development of downstream processes (DSPs) required for the preparation of our UNITE™ pDNA products. In this role, the incumbent will use his/her working knowledge of product recovery, chromatographic purification and TFF to enrich UNITE™-based vaccine products. Process improvements using Design of Experiments (DOE) should be considered to develop more robust methods and will serve as the basis to generate MBRs for internal production or Tech Transfer to a qualified CMO. Strong background in biochemistry and molecular biology as it pertains to product development is required.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Work with minimal supervision toward achieving Strategic Goals against agreed upon timelines
  • Develop, direct and execute work as technical lead for down-stream process optimization
  • Develop SOP’s, batch records and provide technical support and training to others
  • Working knowledge of Purification Methods
    • Recovery by centrifugation or phase separation
    • Chromatographic purification (IEX, HIC)
    • Significant experience in Affinity Resin preparation and purification preferred
    • Tangential Flow Filtration (TFF)
    • Conductivity, Osmolality and Viscosity testing
    • Gel electrophoresis (Agarose, PAGE) and Western blotting
    • HPLC evaluation (IEX, HIC)
    • gPCR Method development
    • Molecular cloning a plus
  • Personnel development (motivated self-starter)
  • Analyze, interpret and present data to project teams and management
  • Strong communication and presentation skills

Competencies & Skills

  • Customer Focus
  • Communication/Presentation Skills
  • Integrity/Ethics
  • Initiative
  • Sense of Urgency
  • Teamwork
  • Collaboration Skills
  • Innovation

Organization Relationships/Supervision/Other

  • Can interact directly with R&D, Quality, Regulatory Affairs and Project Management as an integral part of product development
  • Can interact with external organizations (e.g. Contract Manufacturing, Contract Testing, Contract Development, Equipment vendors)
  • Can have direct supervisory responsibilities
  • Work with Supervisor to establish Departmental Goals
  • Position will require some travel to Conferences and/or Training opportunities
  • Appropriate training and certification as needed in the role

Physical Demands

  • Requires both office and laboratory work
  • Able to lift a minimum of 35 lbs, disassemble and reassemble equipment
  • Exposure to chemicals used in plasmid DNA preparation

Work Environment

  • This job operates in a professional office and laboratory work environment
  • This role requires hands-on laboratory work employing aseptic technique, standard molecular and biochemical process with limited exposure to inorganic and organic compounds
  • This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m.

Required Education and Experience

  • Doctorate degree in Science (Biochemistry, Molecular Biology, Microbiology) with 3 – 5 years of relevant experience
  • Master’s degree in Science (Biochemistry, Molecular Biology, Microbiology) with 5 – 8 years of relevant experience
  • Prior Supervisory experience a plus
  • Able to introduce new technologies to improve downstream process efficiency
  • Independently break down complex problems, propose experimental approach and provide definitive solutions
  • Knowledge in statistical Design of Experiments (DOE) and data analysis
  • Understanding of the cGMPs as it related to documentation and Process Development practices

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Send your cover letter and credentials as described above, along with the Job Code: 2019 PD001 in the subject line, to

Equal Opportunity Employer