Scientist II, Process Development

Cellipont Bioservices • The Woodlands, TX

6d

About The Position

"Bridging innovation to cure" Developing and manufacturing your cell therapies from benchtop to bedside Cellipont Bioservices is growing, and we are looking for a Scientist II, Process Development who believe in the potential bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and it's clients to the next level. The Scientist II, Process Development will be part of the Process Development team and will participate in process development initiatives for our current and future cell therapy programs. This position plays a key role demonstrating the values, culture, and deliverables for the site.

Requirements

• Bachelors or Masters degree with minimum 6-8 years 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
• Experience with mammalian tissue culture including both adherent and suspension cells.
• Experience with standard analytical methodologies (such as Flow Cytometry, ELISA, qPCR-based assays) is required.
• 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
• 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

Nice To Haves

• Experience with common equipment used in cell therapy manufacturing such as Sepax, LOVO, G-Rex, Wave, PBS Bioreactors, CliniMACs Plus, Prodigy, MaxCyte GT is a plus.
• Experience with nucleic acid/viral vector transduction/transfection, and hands-on experience with flow, PCR and cell-based assays is preferred.
• Prior working experience with magnetic cell enrichments and depletions in and closed system cell therapy manufacturing processes are a plus.
• Experience with CAR-T or other cell and gene therapy products and related functional assays a plus
• Experience working in a GMP environment preferred.

Responsibilities

• Design and perform experiments to optimize the processes for various cell therapy programs.
• Perform cell isolation, modification, expansion, 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.

Benefits

• Opportunities for career growth within an expanding team.
• Defined career path and annual performance review & feedback process.
• Cross-functional exposure to other areas 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees