Full-Time
Senior Process Engineer
Cellares
201-500 employees
Develops and manufactures cell therapies
Compensation Overview
$90k - $210k/yr
Senior
San Bruno, CA, USA
- Bachelor’s Degree in a scientific or related field is required
- A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
- Experience with technology transfer in the Pharma/Biotech industry
- Direct experience writing and reviewing cGMP documentation
- Strong analytical, problem-solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
- Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization
- Excellent planning, organization, technical writing, and time-management skills, including the ability to support, problem-solve, and prioritize multiple projects and deadlines
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
- Lead and/or support technology transfer activities at the site level (within, inbound, and outbound), including any scale-up or other process adaptations
- Lead and/or support late stage process development activities including process characterization, comparability, and qualification/validation activities
- Own the technology transfer from Process Development to cGMP Manufacturing operations - author change controls, draft/review/approve SOPs and batch records, train manufacturing personnel
- Support development of manufacturing operations and business processes, including GMP system implementation and tasks related to GMP readiness
- Support labor and equipment capacity modeling and participate in sales and operations planning process (S&OP) for supply review
- Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies
- Provide user needs, requirements, and support implementation and UAT of Cellares software solutions (in-house or enterprise)
- Oversee root cause investigations and train manufacturing personnel to support robust root cause analysis. Facilitate complex cross-functional investigations
- Propose and implement corrective and preventive actions (CAPAs) as necessary and own respective effectiveness checks to ensure recurrence was prevented
- Facilitate and/or own the generation of process or operational-related Failure Modes and Effects Analysis (FMEA) and resulting mitigations and actions
- Develop training and onboarding content and curriculum for new hires and new methods
- Maintain and report process run summaries and continued process verification reports
- Prepare and present data associated with manufacturing processes to internal and external partners, as well as health authority inspectors
- Work with clients on process mapping of the manufacturing processes
- Advanced degree (Masters, PhD) in a scientific or related field
- Experience with Operational Excellence and/or Lean Manufacturing
- Direct experience designing, executing, and supporting process characterization studies
- Direct experience performing root cause analysis and leading complex investigations
Cellares develops and manufactures cell therapies in the biotechnology sector, operating as an Integrated Development and Manufacturing Organization (IDMO) that combines both processes in one facility. Its proprietary "Smart Factory" technology features an automated single-use cartridge system, which boosts productivity by ten times, cuts costs per batch by 50%, and reduces process failure rates by 75% compared to traditional methods. The company serves clients at various stages of cell therapy development and has formed partnerships with major pharmaceutical companies to enhance the manufacturing of CAR-T cell therapies. Cellares aims to streamline the production of cell therapies, making them more efficient and affordable.
Company Size
201-500
Company Stage
Series C
Total Funding
$355M
Headquarters
South San Francisco, California
Founded
2019
Simplify's Take
What believers are saying
- Strategic partnerships, like with Bristol Myers Squibb, enhance scalability and efficiency.
- Expansion into Japan with Mitsui Fudosan boosts international manufacturing capabilities.
- Automated systems reduce costs by up to 70% and increase productivity 10-fold.
What critics are saying
- Over-reliance on partnerships could impact revenue if agreements change.
- International expansion exposes Cellares to geopolitical and regulatory challenges.
- New executive appointments may lead to strategic misalignment or leadership conflicts.
What makes Cellares unique
- Cellares' Cell Shuttle offers 10x scalability over manual cell therapy manufacturing.
- The Smart Factory model integrates development and manufacturing, unlike traditional CDMOs.
- Cell Q automates QC for up to 6,000 cell therapy batches annually.
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Growth & Insights and Company News
6 month growth
↑ 2%1 year growth
↑ 2%2 year growth
↑ 6%Cellares, in collaboration with Mitsui Fudosan, a Japanese real estate developer, established Japan's first next-gen commercial production site for CAR-T cell therapies.
bluebird bio announced on 21 February 2025 that it had entered into a definitive agreement to be acquired global investment firms Carlyle (DC, USA) and SK Capital (NY, USA) for US$3.00 per share in cash, plus a contingent value right of $6.84 per share if certain sales targets are met.
Cellares, a Bridgewater-based leader in automated cell therapy manufacturing, on Monday announced it appointed Ossama Eissa, former executive at Novartis, Lonza Biologics, and Legend Biotech, as chief operating officer.
Cellares, a Bridgewater-based leader in automated cell therapy manufacturing, on Monday announced it appointed Ossama Eissa, former executive at Novartis, Lonza Biologics, and Legend Biotech, as chief operating officer.Eissa’s extensive experience will support the expansion of Cellares’ Smart Factory network in the United States, Europe, Japan and other international markets, addressing the challenges of scalability, cost, and quality that have long hindered patient access. Through these advancements, Cellares will work to ensure that life-saving treatments are accessible for oncology and autoimmune patients globally.This appointment strengthens the Cellares leadership team in a time of rapid global expansion of the company’s IDMO manufacturing services, in response to the growing global demand for cell therapy manufacturing capacity.Eissa brings more than 20 years of experience in pharmaceutical and biotech manufacturing.He formerly served as vice president and general manager at Legend Biotech, where he led the Raritan production site through the global launch of Carvykti, a CAR-T cell therapy.At Lonza Biologics, Eissa managed Global Strategic Projects, contributing significantly to the Cell and Gene Technologies Business Unit by boosting manufacturing efficiency and driving commercial scale-up. He also oversaw U.S. manufacturing operations at Novartis, scaling production and supporting regulatory approval for Kymriah, the first FDA-approved CAR-T cell therapy.“Joining Cellares is an opportunity to address one of the biggest challenges in healthcare today: making cell therapies accessible to all of those who need them,” Eissa said. “The mission aligns closely with my experience in scaling complex manufacturing systems to benefit patients directly. I’ve witnessed the profound impact these treatments have, and I’m committed to ensuring that we reach more patients, especially those facing cancer and autoimmune diseases, with the reliability and speed they deserve.”
Self-acclaimed integrated development and manufacturing organization (IDMO) Cellares has partnered with Sony Corporation, a technology firm focused on the field of flow cytometry, to integrate advanced flow cytometry-based cell analysis and sorting solutions into the Cellares Cell Shuttle platform.