Process Development Scientist - Downstream

Position Opportunity

Seeking multiple Process Development scientist roles for Downstream. The Process Development scientist will develop, optimize, and scale downstream purification processes for biologics, including viral vectors and bacteriophages, to support client programs and manufacturing technology transfer. Responsibilities include clarification, chromatography, tangential flow filtration and final filtration, with emphasis on product recovery, purity and process consistency.

This opening may be filled at the Associate Scientist, Scientist I, Scientist II or Scientist III level based on relevant education, experience, and demonstrated technical capability. Scope, independence and technical leadership will be commensurate with the appointed level.

This position is in the Bryan-College Station area and requires on-site work five business days per week, with off-shift and weekend work as required.

How you will make an impact

• Execute downstream studies in clarification, chromatography, ultrafiltration/diafiltration and final filtration; analyze recovery, impurity clearance and process performance, and propose solutions.
• Author or assist with protocols, SOPs, process descriptions, technical reports and manufacturing batch record content; present findings to team members, leadership and clients as appropriate to level.
• At Associate Scientist / Scientist I levels, execute assigned studies with guidance appropriate to experience. At Scientist II / III levels, independently design and lead studies, troubleshoot processes and train colleagues.
• At Scientist III level, serve as a downstream technical SME, assess client processes for GMP suitability and scale-up needs, and lead downstream technology transfer with technical support to Manufacturing.
• At Scientist III level, lead onboarding and training, assist with recruitment and interviews, and propose improvements to methods, documentation, procedures and safety.
• Operate and maintain automated chromatography systems (e.g., AKTA), TFF systems, clarification and filtration equipment, pumps, balances, tubing welders/sealers and pH/conductivity meters; prepare buffers and solutions.
• Maintain laboratory readiness, equipment records, consumables and reagents; follow cleaning, contamination control and safe material-handling procedures.
• Collaborate with PD, Analytical Development, Manufacturing, Quality and other stakeholders; support study planning, scheduling and resource estimates as appropriate to level.
• Maintain clear communication with the team and leadership. Perform other duties as required.

Education

All levels: Bachelor's degree in a relevant scientific or engineering discipline, such as Biology, Biochemistry, Microbiology, Biotechnology, Chemical Engineering or Bioengineering. An advanced degree is not required.

Experience

• Associate Scientist: 0-2 years of relevant laboratory experience. Academic research and internships will be considered; foundational knowledge of purification and laboratory techniques is required.
• Scientist I: 2+ years of relevant process development experience in a cGMP, cGLP and/or FDA-regulated environment, with hands-on downstream purification capability.
• Scientist II: 3-4+ years of relevant process development experience in a cGMP and/or FDA-regulated environment, with independent study execution, data interpretation, troubleshooting, scale-up and technology transfer experience.
• Scientist III: 6+ years in a biotechnology process development role with cGMP experience. Demonstrated downstream technical expertise, experimental design, process assessment, scale-up and technology transfer capability.
• Level placement will prioritize the relevance and quality of hands-on experience and demonstrated technical capability. Work ethic, reliability and willingness to learn are valued at every level.
• Experience purifying products from bacterial or other microbial processes is preferred, including clarification, chromatography, membrane processing and host-cell impurity/endotoxin removal. Bacteriophage purification experience is an advantage. Relevant viral-vector or other biologics purification experience will also be considered.

Skills

• Purification principles, aseptic handling and downstream equipment proficiency appropriate to the appointed level.
• For Scientist II / III: experimental design, data analysis and technical writing; familiarity with DoE and statistical tools (e.g., JMP) is preferred.
• Collaboration, attention to detail, verbal and written communication, organization, record keeping and planning.
• Integrity, discretion and confidentiality; ability to wear appropriate PPE and follow laboratory safety and contamination control procedures.

Qualities & Attitude

Strong work ethic, reliability, initiative and willingness to learn through hands-on training and feedback. Proactive and self-motivated, with good written and oral communication and the ability to work collaboratively within a team and across departments.