Senior Scientist Process Development

Secretome Therapeutics • Plano, TX

2d

About The Position

Secretome is seeking a highly motivated Senior Scientist, Process Development, to lead process development and optimization in support of novel allogeneic cell therapies. Reporting directly to the Head of Process Sciences, this role designs, optimizes, and scales cell-processing workflows; executes cell-processing runs; and helps ensure high yield, product quality, and regulatory compliance.

The role works closely with Analytical Development, cross-functional teams, and external organizations to establish fit-for-purpose processes, generate high-quality data, support process understanding and product characterization, and transfer processes into a GMP environment. It also contributes to technology development, laboratory operations, regulatory filing materials, and GMP manufacturing plans.

Requirements

• Ph.D. with at least 4 years, or master's degree with at least 6 years, of relevant industry experience in cell therapy process development.
• Strong hands-on experience with stirred-tank bioreactors at various scales.
• Innovative, problem-solving, and organizational skills.
• Ability to design and execute cell process development, assist with process gap analysis, and provide scientific guidance and recommendations on process optimization.
• Hands-on experience in upstream and downstream bioprocessing.
• Familiarity with FDA regulatory requirements for drug products and IND filings.
• Knowledge of cGMP requirements for processes and technology transfer.
• Ability to troubleshoot technical challenges and resolve them to produce cell therapy products at a high-performance rate.
• Strong interpersonal and communication skills, ability to work as a team player, and willingness to work cross-functionally.

Nice To Haves

• In-depth knowledge of biotherapeutics processes.
• Experience using small- and medium-scale stirred-tank bioreactors for cell therapies.

Responsibilities

• Optimize cell therapy workflows from cell expansion through harvest and formulation.
• Execute small- to medium-scale cell processing in 3D bioreactors.
• Resolve process challenges and explore alternative equipment or production units.
• Coordinate in-process sampling and characterization of cell products and relevant product attributes with the Analytics team.
• Troubleshoot existing processes and experimental challenges, identify root causes, implement scientifically sound solutions, and propose improvements to senior management.
• Develop protocols, reports, technical summaries, and other scientific documentation in accordance with company procedures and applicable regulatory expectations.
• Maintain accurate laboratory records and ensure work follows safety and compliance requirements.
• Present results, scientific conclusions, and process improvements to cross-functional project teams.
• Support laboratory operations and ensure materials and equipment are ready.
• Develop and implement novel technologies for integration into new and existing drug products.
• Develop platforms to support current and new product formats, increase product control, and reduce cost and laboratory operational complexity.
• Participate in project team meetings and decisions, collaborating with Research, Analytical, Manufacturing, Program Management, and other functions.
• Prepare and present plans and roadmaps to collaborators and external entities, including CDMOs, to meet GMP manufacturing goals.
• Support process technology transfer and serve as a subject matter expert with external organizations.
• Support Chemistry, Manufacturing, and Controls (CMC) sections for IND and BLA regulatory filings.
• Support the generation of batch records and technical transfer packages.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior