Senior Scientist, Process Development with experience in Lentivirus, Extracellular Vesicle (EV), Exosomes or EV/Exosome-based therapeutics

Job Summary

Cellipont Bioservices is seeking a Senior Scientist, Process Development with experience in Lentivirus, Extracellular vesicle (EV), Exosomes or EV/Exosome-based therapeutics. The ideal candidate is passionate about bridging client discoveries to patient cures and eager to contribute to the company's growth.

About the role

The Senior Scientist, Process Development will be part of the Process Development team and will participate in process development initiatives for current and future therapy programs. This role requires a deep understanding of mammalian cell culture processes, purification workflows, and formulation techniques.

Responsibilities

• Design, optimize, and perform experiments to optimize processes for various therapy programs.
• Design, optimize, and perform mammalian cell culture processes using bench-scale to high-scale bioreactors.
• Design, optimize, and perform harvest and clarification strategies using depth filtration, tangential flow filtration (TFF), or centrifugation.
• Design, optimize, and perform purification workflows using chromatography (e.g., size-exclusion, ion-exchange, affinity) for isolation while removing host cell proteins (HCP) and DNA.
• Design, optimize, and perform ultrafiltration/diafiltration (UF/DF) parameters for final concentration and buffer exchange into stable formulations.
• Perform cell isolation, modification, expansion, feeding and cryopreservation utilizing functionally closed systems.
• Avoid process gaps through identification and implementation of appropriate equipment and process development recommendations.
• Coordinate with analytical development to test and characterize the product that is in development.
• Lead and support discussions with clients for process development projects.
• Prioritize work to meet timelines and deliverables.
• Support the Business Development team by attending technical calls with prospective clients.
• Assist in interaction with clients, key suppliers, and other external vendors.
• Execute and document laboratory procedures with great attention to detail.
• Maintain detailed records in compliance with applicable cGMP, safety, and environmental requirements.
• Develop internal documentation, protocols, and reports to support transfer of processes to Manufacturing group.
• Perform data analysis and basic statistical analyses.
• Monitor and perform lab preventive maintenance activities as needed.
• Contribute at an individual level as well as part of an organized team in a fast-paced environment.
• Perform other duties as assigned.

Requirements

• Bachelor's or Master's degree with 4-6 years minimum of industry experience OR PhD with 1-2 years minimum of industry experience within pharmaceutical or biotech environment.
• Prior experience in Process Development for Cell and Gene Therapy.
• Prior experience with Lentiviral or EV upstream processing, including hands-on experience with mammalian tissue culture including both adherent and suspension cells, and bioreactors (e.g., stirred-tank and rocking-motion).
• Prior experience with Lentiviral or EV downstream processing, including purification unit operations such as preparative chromatography (affinity, ion-exchange), tangential flow filtration (TFF), and filtration.
• Experience with Formulation & Concentration, including ultrafiltration/diafiltration (UF/DF) parameters for final EV concentration and buffer exchange into stable formulations.
• Experience with common equipment used in lentivirus or EV therapy manufacturing such as Bioreactors, filtration, Tangential Flow Filtration (TFF) and Chromatography Systems.
• Experience working in a GMP environment preferred.

Qualifications

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills, with proven ability to meet deadlines.
• Ability to design and execute experiments with minimal technical supervision.
• Strong analytical and problem-solving skills.
• Proficient with Microsoft Office Suite or related software.

Physical Requirements

• Prolonged periods of standing in clean room and at times, sitting at a desk and working on a computer.
• Must be able to lift 15 pounds at times.
• Manual dexterity to evaluate, install, and modify equipment.

Position Benefits

• Opportunities for career growth within an expanding team.
• Defined career path and annual performance review & feedback process.
• Cross-functional exposure to other areas of within the organization.
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members.
• 401K strong employer match.
• Tuition Reimbursement.
• Employee Referral Bonuses.
• Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays.
• Gain experience in the cutting-edge cell therapy space.

Notice to Agency and Search Firm Representatives

Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.