What are the responsibilities and job description for the Downstream Process Development Scientist Senior Scientist Engineer position at Engage Scientific?
Downstream Process Development Scientist/Engineer
, Manufacturing & Controls (CMC)
Reports ToVice President, CMC
Employment TypeContract
LocationCambridge, MA
Position Overview
Our client is seeking a highly motivated Downstream Process Development Scientist/Engineer to develop and optimize purification processes for therapeutic antibodies and recombinant proteins produced in mammalian cell culture. Reporting to the Head of CMC, this hands-on role will drive affinity capture resin screening, chromatography method development, and process optimization to enable robust and scalable downstream manufacturing process.
Key Responsibilities- Evaluate and optimize affinity capture resins (e.g., Protein A and alternative affinity ligands) to maximize antibody recovery, yield, and resin performance.
- Perform resin screening, condition optimization, and scale-down studies to establish robust and scalable purification processes.
- Develop and optimize chromatography purification steps, including ion exchange (IEX), hydrophobic interaction (HIC), and mixed-mode chromatography using systems such as ÄKTA.
- Design and optimize polishing steps to achieve target product purity and removal of process-related impurities (e.g., host cell proteins, aggregates, DNA).
- Analyze purification samples using common analytical techniques (e.g., HPLC/UPLC, SEC, CE-SDS, ELISA, HCP assays) and accurately interpret data to guide process development decisions.
- Maintain thorough experimental documentation and data records to support process development reports, regulatory documentation, and technology transfer.
- Collaborate with analytical development and external partners (e.g., CDMOs) to ensure integrated and efficient process development.
- Support technology transfer of downstream purification processes to manufacturing partners and assist with process troubleshooting during scale-up.
- B.S., M.S., or Ph.D. in Biotechnology, Chemical Engineering, Bioengineering, or a related field with relevant industry experience (B.S. 5 years, M.S. 3 years, or Ph.D. 1 year).
- Hands-on experience purifying antibodies or recombinant proteins from mammalian cell culture supernatant using chromatography systems (e.g., ÄKTA or equivalent).
- Proficiency with chromatography systems and multiple separation modes, including affinity, ion exchange (IEX), hydrophobic interaction (HIC), and size exclusion chromatography (SEC).
- Perform resin screening, condition optimization, and scale-down studies to establish robust and scalable purification processes.
- Experience working with downstream unit operations, such as harvest clarification, chromatography purification, and ultrafiltration/diafiltration (UF/DF); familiarity with viral clearance strategies is a plus.
- Experience working in cross-functional teams including upstream development, analytical development, quality and manufacturing.
- Strong data analysis and experimental design skills; experience with Design of Experiments (DoE) is a plus.
- Ability to analyze and interpret purification data to guide process optimization.
- Experience supporting process scale-up and technology transfer to CDMOs or manufacturing partners.
- Opportunity to make a direct impact in an innovative biotech and help develop a commercial product
- Highly collaborative, mission-driven culture
- Strong investor support