Associate Scientist - MSAT

The Associate Scientist - Manufacturing Sciences and Technology will be working at the intersection of process development and clinical/commercial production.

The associate scientist will be responsible for supporting product and process optimization studies, technology transfer activities, and process characterization studies. This position will also involve routine data analysis in support of root cause analyses and experimental outcome interpretation.

DUTIES AND RESPONSIBILITIES:

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• Support technology transfer, process characterization, and technology evaluation of cell therapy manufacturing processes.
• Support deviation, out-of-specification (OOS), out-of-trend (OOT) investigations.
• Perform tech transfer activities, including process, instrumentation, documentation, facility, gap and risk assessments.
• Assist with data analysis of development and clinical/commercial production data to enable
• Asist with the preparation of technical documents, including
  -but not limited to-, standard operating procedures, process development and/or characterization reports, comparability assessments, risk assessments.
• Conduct routine laboratory maintenance and management including equipment maintenance, inventory, and organization.

QUALIFICATIONS:

Education:

• B.S. or M.S. in cell and/or molecular biology, engineering, or relevant discipline with 0-2 years working in the pharmaceutical industry,

Core competencies:

• Experience working with closed-system, manual, and automated cell processing platforms; bioreactor systems, harvest processes, and analytical equipment.
• Ability and aptitude for following established experimental procedures competently and independently, assisting with the interpretation of results.
• Learn and understand new experimental techniques, demonstrated ability to modify protocols depending on project need.

Soft skills:

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Effectively communicate scientific data and concepts to internal audiences through reports and presentations.
• Demonstrable ability to work independently
• Motivated and fast learner

Desirable:

• Experience in a biotechnology company with emphasis on immunological systems, cell therapy, gene therapy, and large-scale process development and improvement.
• Experience in a cGMP or GLP environment

COMPETENCIES:

• Adaptability - Adapts to changes in the work environment;
  Manages competing demands;
  Changes approach or method to best fit the situation;
  Able to deal with frequent change, delays, or unexpected events.
• Computer Skills - Skilled with computers;
  Takes advantage of new technology;
  Learns new tools quickly;
  Uses technology to enhance job performance.
• Initiative - Volunteers readily;
  Undertakes self-development activities;
  Seeks increased responsibilities;
  Takes independent actions and calculated risks;
  Looks for and takes advantage of opportunities;
  Asks for and offers help when needed.

• Motivation - Sets and achieves challenging goals;
  Demonstrates persistence and overcomes obstacles;
  Measures self against standard of excellence;
  Takes calculated risks to accomplish goals

• Teamwork - Balances team and individual responsibilities;
  Exhibits objectivity and openness to others' views;
  Gives and welcomes feedback;
  Contributes to building a positive team spirit;
  Puts success of team above own interests;
  Able to build morale and group commitments to goals and objectives;
  Supports everyone's efforts to succeed.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus

WORK ENVIRONMENT:

• The noise level in the work environment usually is quiet.