What are the responsibilities and job description for the Senior Scientist, Process Development position at Cellipont Bioservices?
Job Summary
Cellipont Bioservices is growing, and we are looking for a Senior Scientist, Process Development who believes in bridging client discoveries to patient cures.
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 cell therapy programs. This position plays a key role demonstrating the values, culture, and deliverables for the site.
The Senior Scientist will work independently as well as collaboratively within a high-functioning project team within the Process development and play a key role in driving process optimization, scale-up, and technology transfer for our cell therapy programs. As a senior-level scientist, you will also provide technical leadership, mentor junior staff, and ensure projects meet critical deliverables and timelines.
The Role
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.
Cellipont Bioservices is growing, and we are looking for a Senior Scientist, Process Development who believes in bridging client discoveries to patient cures.
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 cell therapy programs. This position plays a key role demonstrating the values, culture, and deliverables for the site.
The Senior Scientist will work independently as well as collaboratively within a high-functioning project team within the Process development and play a key role in driving process optimization, scale-up, and technology transfer for our cell therapy programs. As a senior-level scientist, you will also provide technical leadership, mentor junior staff, and ensure projects meet critical deliverables and timelines.
The Role
- Design, plan, and execute complex experiments to optimize processes for various cell therapy programs (e.g., CAR-T, MSCs, EVs and other cell and gene therapies).
- Serve as a subject matter expert for various cell therapy processes, providing guidance and technical oversight to junior scientists.
- Identify and implement new equipment or technologies to develop highly robust and reproducible processes.
- Develop and refine scale-up or scale-out approaches for different cell types and manufacturing platforms (e.g., bioreactors, functionally closed systems).
- Oversee process characterization, applying risk assessment tools (e.g., FMEA) and data analysis software (e.g., JMP, FlowJo, PRISM or similar) to ensure robust and well-understood processes.
- Coordinate cross-functional efforts with Analytical Development, Manufacturing, and Quality teams to ensure seamless technology transfer and alignment on process requirements.
- Manage multiple client campaigns, overseeing timelines, data review, troubleshooting, and resource allocation.
- Support internal development or initiatives, proposing innovative ideas for continuous improvement and evaluation of new technologies.
- Lead and support technical discussions with clients regarding process development strategies, progress updates, and data review.
- Participate in drafting proposals, budgets, and statements of work for new or expanded client projects.
- Ensure project milestones and deliverables are met, addressing any risks or challenges proactively.
- Review and approve technical reports, batch records, and SOPs; ensure compliance with regulatory guidelines and cGMP requirements.
- Perform thorough data analyses and interpretation, presenting findings in written reports and oral presentations to internal teams and clients.
- Maintain detailed records of all development work in compliance with cGMP, safety, and environmental standards.
- Provide training, guidance, and mentorship to junior staff members, fostering a collaborative and high-performing team culture.
- Participate in recruiting efforts to secure and onboard new scientists, contributing to team growth and development.
- Actively champion a safe work environment, ensuring compliance with all safety and environmental policies.
- Perform other duties as assigned in a fast-paced, evolving environment.
- Bachelor's or Master's degree in a relevant scientific discipline with 10 years of industry experience, OR
- PhD in a relevant scientific (molecular biology/Cell biology etc.) discipline with 4-6 years of industry experience in cell therapy, or biologics.
- Proven track record in process development for cell and gene therapy is required.
- Extensive experience with mammalian tissue culture (adherent and/or suspension) and common cell therapy equipment (e.g., Sepax, LOVO, G-Rex, Wave, CliniMACs etc.).
- Hands-on experience with development and optimization of cell therapies
- Familiarity with process characterization methodologies (e.g., FMEA) and statistical analysis software (e.g., JMP, PRISM, FlowJo, NOVO express) strongly preferred.
- Experience working in a GMP environment and with closed-system cell therapy processes is highly desirable.
- Demonstrated experience leading teams or projects, with strong organizational and time-management skills.
- Ability to work collaboratively across departments (e.g., PD, MS&T, QA/QC, Manufacturing) to drive process improvements and technology transfer.
- Excellent verbal and written communication skills, including the ability to present data effectively to both technical and non-technical audiences.
- Strong analytical and problem-solving abilities; comfortable troubleshooting complex scientific challenges.
- 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
- 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.
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.