Manager, Process Development

4 months ago

Spring, United States Cellipont Bioservices Full time
Job DescriptionJob Description

"Bridging Innovation to Cure"

Developing and Manufacturing your cell therapies from benchtop to bedside

Job Summary:

Cellipont is a Contract Development and Manufacturing Organization (CDMO), seeking a highly motivated and experienced Cell Therapy Process Development Manager to lead a dynamic team focused on advancing cell therapy processes for our clients. In this critical role, you will be responsible for overseeing all aspects of process development and play a pivotal role in ensuring the success of our clients' cell therapy programs, from pre-clinical to commercial stages.

The Role

  • Provide scientific and technical leadership to the cell process development team.
  • Lead and empower a team of scientists in developing and optimizing robust, scalable, and cGMP-compliant cell therapy processes for a diverse client base.
  • Partner closely with clients to understand their unique needs. Develop and execute comprehensive process development plans, adhering to sound scientific principles and best practices.
  • Identify and implement novel technologies and equipment to improve process efficiency and cell product quality.
  • Champion the seamless transfer of technology from pre-clinical to clinical and potentially commercial manufacturing stages.
  • Spearhead process characterization studies to establish critical process parameters (CPPs) for consistent and reliable manufacturing.
  • Draft and review technical documents, including development reports, process descriptions, risk assessments, SOPs, and MBRs, and ensure that the process development activities comply with regulatory requirements (e.g., cGMP).
  • Support the business development team by attending technical calls with prospective clients.
  • Author and review proposals as needed.
  • Collaborate effectively with cross-functional teams (Analytical Development, MS&T, Manufacturing, and Quality) to ensure seamless process transfer into GMP.
  • Develop and maintain robust process documentation, including protocols, SOPs, and batch records.
  • Foster a collaborative and innovative work environment within the process development team.
  • Represent the cell therapy process development team at internal and external meetings.
  • Manage project timelines, budgets, and resources to ensure successful project execution.
  • Stay at the forefront of the cell therapy field, actively researching and implementing novel process development technologies.

The Candidate

  • MS/PhD in Cell Biology, Immunology, or a related field.
  • Minimum 10 years of experience in cell therapy process development, ideally within a CDMO environment, and a demonstrable track record of successful client project delivery.
  • Proven track record of leading and mentoring scientific teams.
  • Strong understanding of cell therapy manufacturing principles, including aseptic processing, cell expansion, and cryopreservation.
  • Experience in designing and executing experiments to optimize cell therapy processes.
  • Excellent knowledge of cGMP regulations and quality by design (QbD) principles.
  • Hands-on experience with standard cell therapy laboratory equipment and technology platforms
  • Demonstrated ability to manage projects, timelines, and budgets.
  • Adeptness at building strong relationships with clients, effectively managing expectations, and fostering trust.
  • Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific concepts to both technical and non-technical audiences.
  • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
  • Excellent organizational skills and attention to detail.
  • Excellent time management skills, with proven ability to meet deadlines.
  • Strong analytical and problem-solving skills.
  • Ability to critically analyze the data and present data in internal and external meetings.
  • Proficient with Microsoft Office Suite or related software.
  • Experience working in a fast-paced, client-centric CDMO environment is highly preferred.

Physical Requirements:

  • Prolonged periods of standing in a clean room and at times, sitting at a desk and working on a computer.
  • Ability to lift 15 pounds at a time
  • 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



"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here"


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.

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