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Lead Process Engineer
2 months ago
Position Overview
Cellares Corporation is on the lookout for a dynamic and highly skilled Senior Process Engineer to become a vital part of our MSAT team, playing a crucial role in the advancement of our cutting-edge cell therapy manufacturing platform.
This role encompasses a range of responsibilities related to the development, transfer, compliance, and scalability of Cellares' manufacturing operations. The selected candidate will primarily focus on facilitating technology transfers from Process Development to cGMP manufacturing while also spearheading the development of process automation aimed at enhancing reliability, safety, cost-efficiency, scalability, and compliance. Additionally, this individual will provide shop floor support and act as a subject matter expert (SME) across all facets of the manufacturing process.
This position requires a multidisciplinary approach, necessitating effective collaboration with both internal and external stakeholders across various functional areas to devise optimal solutions. The ideal candidate will be recognized as an expert in technology transfer and Manufacturing Science and Technology, working closely with diverse teams to ensure all deliverables are achieved.
We seek candidates who thrive in a fast-paced, mission-oriented environment and are ready to address a wide array of challenges as the organization expands.
Key Responsibilities- Convert client requirements into actionable project plans.
- Oversee technology transfer initiatives at the site level, including scale-up and process adaptations.
- Lead and support late-stage process development activities, including characterization and validation efforts.
- Manage the transition of technology from Process Development to cGMP Manufacturing, including authoring change records and drafting SOPs.
- Assist in the development of manufacturing operations and business processes, ensuring GMP system readiness.
- Contribute to labor and equipment capacity modeling and engage in sales and operations planning (S&OP).
- Define user requirements for process equipment across multiple facilities for cell therapy production.
- Provide support for the implementation and user acceptance testing of Cellares software solutions.
- Conduct root cause investigations and train personnel to ensure robust analysis.
- Recommend and implement corrective and preventive actions (CAPAs) as necessary.
- Facilitate the creation of process-related Failure Modes and Effects Analysis (FMEA) and corresponding action plans.
- Develop training materials and onboarding content for new employees.
- Maintain and report on process run summaries and ongoing process verification.
- Prepare and present manufacturing process data to internal and external stakeholders.
- Support process qualification and validation activities.
- Collaborate with clients on mapping manufacturing processes.
- Bachelor's Degree in a scientific or related discipline is essential.
- A minimum of 5 years of experience in the biotech or biopharma sector, particularly in cGMP Operations related to cell and gene therapy.
- Proven experience in technology transfer within the Pharma/Biotech industry.
- Experience in drafting and reviewing GMP documentation is required.
- Strong analytical, problem-solving, and critical thinking abilities, with a capacity to lead change initiatives.
- Excellent teamwork and interpersonal skills, capable of influencing and building relationships at all organizational levels.
- Familiarity with Operational Excellence and Lean Manufacturing principles is advantageous.
- Outstanding planning, organizational, technical writing, and time-management skills, with the ability to manage multiple projects effectively.
Compensation and Benefits
The total compensation package at Cellares includes competitive base salaries, comprehensive Medical, Dental, and Vision Plans, 401(k) Matching, and Stock options.
About Cellares
Cellares is pioneering the Integrated Development and Manufacturing Organization (IDMO) model, utilizing an Industry 4.0 approach to mass-produce the living drugs of the future. Our innovative Cell Shuttle technology integrates all necessary components for the entire manufacturing process, enabling high-throughput automation. Cellares aims to partner with academic institutions, biotechs, and pharmaceutical companies to expedite drug development and enhance manufacturing scalability.
The company is headquartered in South San Francisco, California, with a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Cellares is supported by leading investors and has successfully raised substantial financing.
