Cell Therapy Manufacturing Specialist at Cellares

Bridgewater, New Jersey, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotech, Biopharma, Cell TherapyIndustries

Requirements

Bachelor’s Degree or diploma in a scientific or related field
1+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
Adherence to cGMPs at all times during the manufacturing of Cell Therapy products
Proficiency in Drug Product-related process equipment
Experience following protocols, SOPs, and/or GMP documentation
Excellent verbal, written, presentation, and interpersonal skills
Strong analytical and problem-solving skills
Self-motivated and passionate about advancing the field of cell therapy

Responsibilities

Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
Execute manufacturing processes in both an R&D and GMP environments, following protocols and/or standard operating procedures (SOPs)
Provide user feedback to engineering and process teams, support with requirements gathering and review
Contribute to analysis and presentation of technical results at departmental meetings
Support reagent preparation, leukopak processing, and sample testing in an R&D and GMP environment
Perform routine clean room and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
Assist in the execution of process, equipment, and cleaning validation
Initiate and support the closure of Deviation Reports and CAPAs
Revise and originate production records, standard operating procedures, protocols, and reports
Work with Quality Control, Facilities, Materials Management, Quality Assurance, and Validation to complete assignments
Ensure batch records are turned in to area management within specified days of completion
Train and mentor new manufacturing associates on procedures, aseptic techniques, equipment, and trouble-shooting skills
Review in-process and completed documents for accuracy
Other duties as assigned

Skills

Key technologies and capabilities for this role

cGMPGMP OperationsSOPsBatch RecordsCell Therapy ManufacturingLeukopak ProcessingReagent PreparationClean Room OperationsSample TestingProcess Equipment

Questions & Answers

Common questions about this position

What is the salary for the Cell Therapy Manufacturing Specialist position?

This information is not specified in the job description.

Is this position remote or does it require on-site work?

This information is not specified in the job description.

What skills are required for this role?

Required skills include proficiency in Drug Product-related process equipment, experience following protocols, SOPs, and GMP documentation, excellent verbal, written, presentation, and interpersonal skills, and strong analytical and problem-solving skills.

What is the company culture like for this position?

The role is within a fast-paced, mission-driven environment where candidates enjoy tackling challenges as the company grows, on the Process Sciences team.

What makes a strong candidate for this Cell Therapy Manufacturing Specialist role?

Strong candidates have a Bachelor’s Degree in a scientific field, 1+ years of biotech/biopharma experience in cGMP Operations (preferably cell and gene therapy), GMP knowledge, and are self-motivated with passion for cell therapy.

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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