Supervising Principal Scientist, Process Development at Cellares

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Cell TherapyIndustries

Requirements

Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 6-20 years of process development experience in the cell and gene therapy field
Subject-matter expert in T cell, HSC, iPSC or other immune cell therapy modalities
Extensive hands-on experience with commercial cell processing instruments (Miltenyi Prodigy, Lonza Cocoon, Xuri Wave)
Familiarity with diverse cell editing and payload delivery technologies (LVV, RVV, LNP, CRISPR, TALENs, ZFNs, etc.)
Excellent verbal and written communication skills; Able to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical and non-technical audiences
Knowledge and understanding of cGMP regulations and ICH guidelines preferred
Self-awareness, integrity, authenticity, enthusiasm and a growth mindset

Responsibilities

Lead multifaceted process development efforts to drive continuous improvement of the Cellares platform
Interface directly with external partners to facilitate technology transfer, data reviews, and overall program governance
Develop and manage program timelines for process development
Perform gap assessments and develop thorough development plans, statements of work, test plans, protocols, and any other applicable documents
Coordinate day-to-day team efforts by managing, mentoring and providing technical training to junior team members
Prepare and present technical and organizational updates and forward-thinking proposals to Technical Operations leadership
Lead technology transfer efforts to implement new processes and technologies in collaboration with Analytical Development, MSAT, Quality, Manufacturing, Alliance Management and Engineering
Evaluate and recommend new technologies for benchmark testing with Cellares instruments
Author and review technical documents, procedures, reports and presentations to ensure accuracy and quality

Skills

Cell Therapy

Process Development

Technology Transfer

People Management

Mentoring

Gap Analysis

Program Management

Test Plans

Protocols

MSAT

Analytical Development

Quality

Manufacturing

Alliance Management

Benchmark Testing

Cellares

Develops and manufactures cell therapies efficiently

About Cellares

Cellares develops and manufactures cell therapies in the biotechnology sector, operating as an Integrated Development and Manufacturing Organization (IDMO). Its proprietary "Smart Factory" technology features an automated single-use cartridge system, which increases productivity and reduces costs and process failures compared to traditional methods. The company serves a range of clients, including pharmaceutical companies, and aims to provide efficient and cost-effective manufacturing services for cell therapies. Cellares stands out by combining development and manufacturing processes under one roof, making it a competitive option in the industry.

South San Francisco, CaliforniaHeadquarters

2019Year Founded

$345.3MTotal Funding

SERIES_CCompany Stage

Industrial & Manufacturing, BiotechnologyIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Stock Options

Risks

Emerging biotech startups threaten Cellares' market share with similar solutions.

Potential regulatory delays could impact scaling of new automated systems like Cell Q.

Supply chain vulnerabilities may disrupt production timelines for Cell Shuttle and Cell Q.

Differentiation

Cellares' Cell Shuttle offers 10x scalability over manual cell therapy manufacturing.

The Smart Factory technology integrates development and manufacturing, unlike traditional CDMOs.

Cell Q automates QC processes, addressing bottlenecks in cell therapy quality control.

Upsides

Partnership with Sony enhances precision in cell therapy manufacturing processes.

Strategic partnership with Bristol Myers Squibb provides financial boost and validation.

Ossama Eissa's appointment as COO accelerates global expansion and operational capabilities.

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