Senior Scientist, Process Development

Job Summary

Cellipont Bioservices is growing, and we are looking for aSenior Scientist, Process Development with experience inLentivirus, Extracellular vesicle (EV), Exosomes or EV/Exosome-based therapeutics who believes in the potential bridging clients discoveries to patient cures and who want to challenge the status quo and take Cellipont and it's clients to the next level. The Senior Scientist, Process Development will be part of the Process Development team and will participate in process development initiatives for our current and future therapy programs. This position plays a key role demonstrating the values, culture, and deliverables for the site.

The Role

• Design, optimize and perform experiments to optimize the 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.
• Assist in process gap analysis and provide process development recommendations/plan to close the gaps.
• Identify and implement appropriate equipment to develop highly robust and reproducible processes based on the cell type and unit operation.
• Develop scale-up and scale-out of processes based on the cell type and application.
• 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 the work to meet the timelines and deliverables.
• Provide support to the Business Development team by attending the technical calls with prospective clients.
• Assist in interaction with clients, key suppliers, and other external vendors.
• Successfully execute and document laboratory procedures and experiments 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.
• Performs other duties as assigned.

The Candidate

• Bachelors or Masters 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 is required.
• 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 is required.
• Experience working in a GMP environment preferred.
• 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.