Downstream Process Scientist
Job Title: Senior Research Associate I – Downstream Process Development (Protein Purification)
Job Summary
We are seeking a highly motivatedSenior Research Associate Ito supportprocess development activitiesfocused onbiologics purification . This role involves hands-on laboratory work, execution of purification experiments, data analysis, and collaboration with cross-functional teams to support process optimization, characterization, and technology transfer to GMP manufacturing.
Key Responsibilities
Plan and execute laboratory experiments to supportdownstream process developmentand project goals
Perform protein purification using techniques such aschromatography, tangential flow filtration (UF/DF), and filtration
Analyze and interpret experimental data, ensuring data quality and identifying anomalies
Contribute toprocess optimization, characterization, and scale-up activities
Collaborate with cross-functional teams including Process Development, Analytical, and Manufacturing
Supporttechnology transfer activitiesfrom development to GMP manufacturing
Assist in troubleshooting purification processes and recommending improvements
Document experimental results and contribute totechnical reports, validation documents, and regulatory filings
Present data, results, and conclusions in team meetings
Maintain compliance withcGMP and safety standards , including handling potent compounds upon training
Required Qualifications
BS degreein Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, or related field with2+ years of relevant experience , OR
MS degreein a relevant scientific discipline
Preferred Qualifications
Hands-on experience inbiologics purification / downstream process development
Experience withtangential flow filtration (TFF/UFDF), chromatography, and filtration techniques
Familiarity with purification ofmonoclonal antibodies (mAbs)or other biologics (e.g., bispecifics, fusion proteins, ADCs)
Exposure toanalytical techniquessuch as SEC-HPLC, CE (reducing/non-reducing), or HCP testing
Knowledge ofcGMP environments, process scale-up, and technology transfer
Understanding of downstream unit operations including centrifugation, filtration, chromatography, and virus clearance
Skills & Competencies
Strong experimental design and problem-solving skills
Ability to analyze and interpret complex scientific data
Excellenttechnical writing and documentation skills
Effective communication and collaboration in ateam-oriented environment
Self-motivated, detail-oriented, and eager to learn
Work Environment
On-site laboratory role
Requires adherence to safety protocols and handling ofpotent compounds
Nice to Have
Experience with multiple expression systems (mammalian and microbial)
Exposure to regulatory documentation and process validation