Manager / Senior Manager, Process Development, MSAT
Cirsium Biosciences
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Benefits offered by this job
Job summary
Cirsium Biosciences is seeking a hands-on Manager/Senior Manager, Process Development, MSAT & Technology Transfer to lead upstream and downstream development, tech transfer, and manufacturing readiness. You will collaborate across Research, Process Development, Analytical Development, QA, Regulatory, and Manufacturing to translate early-stage science into scalable, validated manufacturing processes.
The role emphasizes GMP/CMC readiness, cross-functional leadership, and the ability to drive
Qualifications
- Bachelor-level or higher experience in biopharmaceutical process development or related field.
- Experience leading upstream/downstream development and technology transfer.
- Strong GMP/CMC knowledge and regulatory readiness mindset.
- Ability to translate early-stage science into controlled, scalable processes.
- Demonstrated cross-functional collaboration across R&D, QA, Regulatory, and Manufacturing.
- Hands-on leadership with troubleshooting and scale-up activities.
- Experience with technology transfer to internal or external manufacturers.
Responsibilities
- Provide hands-on technical leadership for upstream and downstream process development.
- Lead MSAT activities and bridge Research, Process Development, and Manufacturing.
- Drive scale-up, process characterization, robustness, and process understanding.
- Identify critical parameters and controls; manage technology transfer packages.
- Collaborate with Quality, Regulatory, Analytical Development, and Partners.
- Support transfer to external manufacturing and continuous improvement initiatives.
Skills
Job description
Function: Process Development/Technical Operations
Level: Manager or Senior Manager, based on experience
Position: Full-time
Cirsium Biosciences is seeking a hands-on Manager/Senior Manager, Process Development, MSAT & Technology Transfer to provide technical leadership across upstream and downstream process development and help establish the bridge between Research, Process Development, and future manufacturing.
This is a boots-on-the-ground technical leadership role. The successful candidate will work directly with scientists and technical teams and will be actively involved in development activities, troubleshooting, scale-up, process characterization, and technology transfer.
We are looking for someone who understands how early-stage science becomes a controlled, reproducible, scalable, and transferable manufacturing process. This individual must be comfortable operating in a Research and Process Development environment while bringing strong knowledge of GMP, CMC, regulatory expectations, and manufacturing readiness.
The role will support the full process, including upstream production and downstream recovery, purification, and related unit operations. This individual will work cross-functionally to ensure process knowledge is appropriately developed, documented, and transferred as programs progress.
This position offers significant growth potential and the opportunity to help build Cirsium’s Process Development, MSAT, and Technology Transfer capabilities as the organization grows.
AAV or viral vector process development/manufacturing experience is highly desirable.
Upstream & Downstream Process Development
- Provide hands‑on technical leadership and day‑to‑day oversight of upstream and downstream Process Development activities.
- Partner closely with Research to transition promising early-stage processes and technologies into structured Process Development.
- Support development and optimization of upstream production processes and downstream recovery, clarification, purification, and related unit operations.
- Drive process optimization, scale-up, characterization, robustness, reproducibility, and process understanding.
- Guide identification and evaluation of critical process parameters, critical material attributes, process inputs, operating ranges, process controls, and sources of variability.
- Ensure upstream and downstream development strategies are integrated and evaluate the impact of process changes on subsequent unit operations and product quality.
- Partner with Analytical Development to ensure analytical methods and testing strategies support process understanding, characterization, development decisions, and technology transfer.
- Provide hands‑on troubleshooting and technical support during development, scale-up, and engineering activities.
- Identify technical and operational risks early and work cross-functionally to develop practical mitigation strategies.
- Develop and lead a structured approach for transferring processes from Research into Process Development and from Process Development into internal or external manufacturing.
- Assess process readiness prior to technology transfer and identify technical, analytical, equipment, material, documentation, training, facility, and process‑control gaps.
- Develop and maintain technology‑transfer plans, protocols, reports, process descriptions, and technical transfer packages.
- Ensure development history, process parameters, material and equipment requirements, analytical requirements, known risks, and lessons learned are effectively captured and transferred.
- Provide hands‑on support during engineering runs, scale-up activities, process implementation, troubleshooting, and transfer execution.
- Support technology transfer to other external manufacturing partners as programs advance.
MSAT & Manufacturing Readiness
- Help establish and build Cirsium’s MSAT capability as programs progress toward manufacturing.
- Serve as a technical bridge between Research, Process Development, Analytical Development, Quality, Regulatory, Manufacturing, Facilities/Engineering, and external partners.
- Translate development processes into practical, controlled, and transferable manufacturing processes.
- Support process scale-up, equipment selection, process-fit assessments, facility readiness, and manufacturing-readiness activities.
- Support technical investigations, root-cause analysis, troubleshooting, and corrective actions related to process performance and manufacturing.
- Support process monitoring, trending, continuous improvement, and lifecycle management as programs mature.
- Provide technical input into equipment requirements, qualification strategies, process controls, and manufacturing documentation.
GMP, CMC, & Regulatory Readiness
- Apply phase-appropriate GMP principles as programs transition from Research through Process Development and toward clinical manufacturing.
- Help establish the appropriate transition from exploratory scientific work to controlled development activities.
- Partner closely with Quality and Regulatory to ensure development strategies, process knowledge, and documentation support future CMC and regulatory expectations.
- Ensure appropriate documentation and traceability of development decisions, process changes, critical experiments, technical conclusions, and transfer decisions.
- Provide technical input into risk assessments, change controls, deviations, investigations, CAPAs, equipment qualification, and other quality-system activities as appropriate.
- Support development of process descriptions and technical content for CMC documentation and regulatory submissions.
- Identify development or manufacturing gaps that could create future regulatory, scale-up, technology-transfer, manufacturing, or clinical-supply risks.
Cross-Functional Leadership
- Build strong working relationships across Research, Process Development, Analytical, Quality, Regulatory, Manufacturing, Facilities/Engineering, and other technical functions.
- Provide practical technical leadership while maintaining the flexibility needed in an early-stage Research and Development environment.
- Help establish clear ownership, technical expectations, and handoffs as programs transition between functional groups.
- Mentor and develop technical team members.
- Promote scientific rigor, documentation, accountability, collaboration, and continuous improvement.
- Communicate technical issues, development gaps, and program risks clearly to technical teams and company leadership.
- Bachelor’s degree in Biology, Biochemistry, Biotechnology, Chemical/Biochemical Engineering, Pharmaceutical Sciences, or a related scientific or engineering discipline, or equivalent relevant industry experience.
- A minimum of 8+ years of relevant biopharmaceutical industry experience, with consideration given to the depth and relevance of the candidate’s experience.
- Demonstrated Process Development experience with upstream and/or downstream biologics processes.
- Experience with technology transfer, MSAT, scale-up, process sciences, or manufacturing support.
- Strong working knowledge of GMP, CMC, and phase-appropriate regulatory expectations for biologics or advanced therapies.
- Demonstrated ability to translate Research or early development processes into increasingly controlled, reproducible, scalable, and transferable processes.
- Experience with process characterization, technical troubleshooting, data interpretation, and risk-based decision-making.
- Ability to understand scientific data while recognizing manufacturing, quality, CMC, and regulatory implications.
- Demonstrated ability to work effectively across Research, Process Development, Analytical, Quality, Regulatory, Manufacturing, and Engineering/Facilities functions.
- Strong written and verbal communication skills.
- Willingness and ability to work directly with technical teams in laboratory and manufacturing environments.
- AAV or other viral vector process development or manufacturing experience.
- Cell and gene therapy or other advanced biologics experience.
- Experience spanning both upstream and downstream Process Development.
- Downstream recovery and purification experience.
- Process characterization, scale-up, and manufacturing-readiness experience.
- IND-enabling or early clinical CMC development experience.
- Experience contributing technical content to CMC regulatory submissions or responses.
- Technology transfer to CDMOs or external manufacturing partners.
- Experience helping build Process Development, MSAT, Process Sciences, or Technology Transfer capabilities in an early-stage biotechnology company.
The successful candidate will help Cirsium create a clear and effective pathway from:
This person will help ensure promising science can be translated into processes that are understood, reproducible, scalable, transferable, and ultimately capable of supporting clinical manufacturing.
They will be expected to identify gaps early, work alongside technical teams to solve problems, and bring the appropriate level of GMP, CMC, and regulatory thinking as programs mature.
This role is intended for someone who wants to build a function, not simply inherit one. The initial expectation is hands‑on technical leadership and close involvement with day‑to‑day development activities.
As Cirsium’s programs and manufacturing capabilities mature, this individual will have the opportunity to take on broader responsibility and grow into more senior leadership across Process Development, MSAT, Technology Transfer, and manufacturing support.
The right person will be equally comfortable discussing development strategy with leadership, reviewing data with scientists, troubleshooting a process at the bench, preparing a technology-transfer package, and working with Quality and Regulatory to determine what is needed to move a program forward.
Cirsium Biosciences is an emerging company located in San Diego, California. We offer highly competitive compensation and employee programs, including comprehensive health, dental and vision plans, generous time off, and equity in our early-stage company. We are dedicated to fostering a workplace that keeps our team inspired and engaged. We offer an inclusive company culture where employees feel respected and valued.
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