Biologist Purification Process Development Biologics

Position Details: 

Core Responsibilities

• Develop and optimize protein purification processes for recombinant proteins


• Execute purification workflows using:


• Chromatography (primary)


• Clarification


• Membrane filtration


• Design and run process development and characterization studies
  (including impurity and viral clearance where applicable)


• Perform hands-on lab work (~60%) using purification systems (AKTA/FPLC)


• Support technology transfer (~40%) to pilot-scale and GMP manufacturing


• Troubleshoot purification processes and resolve technical issues


• Analyze and document experimental data using electronic lab notebooks


• Collaborate cross-functionally with:


• Upstream (cell culture / cell line teams)


• Analytical teams


• Present results and participate in technical discussions

Must-Have Requirements 

• Strong hands-on chromatography experience (core requirement)


• Proven experience in protein purification, specifically recombinant proteins


• Direct experience in purification process development (lab-based)


• Background in biologics / biopharmaceutical development


• Hands-on experience with AKTA / FPLC systems


• Education:


• PhD (0-2 years experience) OR


• MS with 5 years relevant industry experience


• Degree in Chemical Engineering, Biochemical Engineering, or related applied field


• Membrane filtration experience (e.g., PendoTech)


• HPLC or similar analytical instrumentation


• DOE / statistical modeling


• Experience with tech transfer to GMP or pilot scale


• Viral clearance / impurity removal studies


• Currently working in biologics purification / downstream process development


• Has personally executed chromatography-based purification workflows


• Comfortable working full-time in lab environment


• Able to collaborate across teams and communicate technical results clearly

Hard Rejection Criteria

• No chromatography experience


• No protein purification experience


• Only upstream / analytical / QC background


• No hands-on lab work


• Non-biologics domain (e.g., small molecules)


• Overqualified (10 years post-PhD)

Required Skills & Qualifications

• Strong scientific understanding of protein separation technologies with the ability to explore and develop new purification approaches


• Experience in chromatography and membrane filtration for biologics purification


• MS or PhD in Chemical Engineering, Biochemical Engineering, or related discipline

Minimum experience:

• MS: 5 years


• PhD: 0-2 years


• Hands-on laboratory experience with AKTA FPLC, PendoTech filtration, and HPLC is a plus

• This role involves working within a biologics purification development team supporting biopharmaceutical process development.


• The candidate will contribute to all aspects of protein purification.

• Develop purification processes using clarification, chromatography, and membrane filtration technologies for recombinant proteins


• Design and execute process development and characterization studies, including impurity and viral clearance studies


• Support technology transfer to scale-up labs and manufacturing facilities


• Perform troubleshooting and investigation activities


• Conduct data acquisition, analysis, and documentation using electronic lab notebooks


• Communicate experimental procedures and results effectively through strong oral and written skills


• Provide technical support for pilot and/or GMP manufacturing of clinical materials


• Evaluate new technologies and innovations for purification processes

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - These all are subject to applicable eligibility).