Director of Enterprise Programs, 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 and Gene TherapyIndustries

Requirements

PhD, M.S. or B.S. in biological sciences (Molecular Biology, Immunology, Genetics)
Excellent organizational and communications skills and strong ability to lead and work with individuals across all levels in the organization
4+ years of experience in the cell and gene therapy manufacturing or process development space, with at least two years in an industry setting
Extensive experience with different modalities of genetically modified cell therapies (e.g. CAR-T, TCR, HSCs, CD34+)
Experience with both autologous and allogeneic cell therapy manufacturing workflows in preclinical, clinical and/or commercial environments
Experience representing companies externally, with strong client relationship management skills
Experience with managing and growing process development teams and processes
Strong experimental design and troubleshooting skills, able to distill complex scientific information into simple and actionable final reports
Experience working in a GMP environment and familiarity with quality requirements
Demonstrated experience in process optimization, characterization and tech transfer
Excellent data analysis skills and experience with a variety of scientific software applications
Great verbal and written communication skills and the ability to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical audiences

Responsibilities

Developing and leading the Enterprise Programs team within the PD department
Managing tech transfer and process development activities to enable regulatory filing
Serving as the company’s internal subject matter expert with regards to cell therapy manufacturing questions associated with all Enterprise Programs
Assuming responsibility for tracking and planning resource allocation, budgets, headcount and continuous team, process and technology improvements
Developing best practices, templates, and standards for transitioning processes from development into characterization and, ultimately, manufacturing
Planning the process development team’s work for the quarters to come with clearly defined goals and resourcing plans
Performing gap analyses and translating existing manual and/or automated processes onto the Cell Shuttle platform
Performing and supporting in the execution of verification, validation, and performance qualification
Authoring standard operating procedures, protocols, and batch records for the manufacturing of Enterprise Program cell therapies
Working with our Analytical Development team to assess and quantify the quality of cell therapy manufacturing process steps in meeting Enterprise Program client requirements
Authoring high-quality regulatory submissions and technical reports; independently prepare and present data/findings at department, project team, and senior management meetings

Skills

Key technologies and capabilities for this role

Cell Therapy ManufacturingProcess DevelopmentTechnology TransferMSATExperimental DesignProcess CharacterizationGene Therapy ManufacturingClient Relationship ManagementPersonnel ManagementResource AllocationBudget PlanningGap Analysis

Questions & Answers

Common questions about this position

What salary is offered for this position?

This information is not specified in the job description.

Is this a remote position, or is there a required location?

This information is not specified in the job description.

What education and experience are required for this role?

A PhD, M.S. or B.S. in biological sciences such as Molecular Biology, Immunology, or Genetics is required, along with 4+ years of experience in cell and gene therapy manufacturing or process development, including at least two years in an industry setting.

What is the work environment like at Cellares?

The role involves working in a fast-paced, mission-driven environment where candidates should be prepared to tackle a broad selection of challenges as the company grows.

What makes a strong candidate for this Director position?

Strong candidates will have extensive experience in cell therapy manufacturing, personnel oversight, client relationship management, experimental design, process development, process characterization, MSAT, and transferring scalable processes from development to manufacturing, along with excellent organizational and communication skills.

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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