Associate Scientist II, Process Development

Worcester, Massachusetts, USA
May 08, 2018
Required Education
Bachelors Degree
Position Type
Full time

We are currently seeking an Associate Scientist II, Process Development to join our team at the AbbVie Bioresearch Center in Worcester, MA. The ideal protein purification manufacturing support engineer/scientist has both laboratory and manufacturing scale process support capabilities. The candidate must be able to conduct laboratory scale experiments for process troubleshooting, optimization and characterization. Commercial scale competencies include knowledge of protein purification unit operations. Responsibilities include providing on-floor support to Operations, troubleshooting, data entry, CPV-compliant trending, and frequent written and verbal updates to project teams and management. Excellent written and verbal communication skills are essential. Support commercial and near-commercial protein purification manufacturing operations utilizing both laboratory and manufacturing scale competencies.

Key Responsibilities Include:

· Execute experiments (e.g. resin lot evaluations for chromatography steps, depth and membrane filter area optimization, UF/DF process optimization, impurity clearance studies, etc.)

· Perform sample analysis (UV, HPLC, ELISA, etc.)

· Assist in process optimization / continuous improvement activities

· Interpret data accurately and independently, with supervisor input

· Document work appropriately in electronic notebook

· Write clear, concise and accurate reports, technical memos and presentations

· Maintain and troubleshoot lab equipment and identify and implement lab optimization projects

· Perform routine analytical methods

Manufacturing support responsibilities:

· Execute CPV-compliant trending program for commercial project(s): gather data from the manufacturing floor, enter/verify data in data trending systems, and assist in response to OOT and non-conforming events and other problems

· Regularly communicate manufacturing project status, including presentations to Project Team meetings and to upper management

· Apply scientific/engineering principles to troubleshoot and improve processes

· Develop technical proficiency with regard to assigned processes

· Assist with preparation of annual regulatory reports and other regulatory agency requests

· Assist with technical transfer of new processes to manufacturing scale

· Assist with implementation of continuous improvement projects

Position will be hired based on level of experience.

Educational Requirements:

  • Bachelor's Degree with typically 3+ years of relevant experience, or Master's Degree with 0+ years of relevant experience, in a biologics process development-related field.
Required Skills:
  • Excellent written and verbal communication
  • Practical knowledge of protein purification unit operations (chromatography, filtration and UF/DF)
  • Competent with Microsoft Office programs
  • Understanding of basic statistics
Preferred Skills:
  • Chromatography workstation experience (programming and running), esp. w/ AKTA / Avant
  • HPLC experience (running and peak integration), esp. w/ Agilent
  • Theoretical understanding of protein separation methods and DOE principles
Equal Opportunity Employer Minorities/Women/Veterans/Disabled