Supervisor, Manufacturing at Cellares

Bridgewater, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Cell Therapy, Pharmaceutical ManufacturingIndustries

Requirements

Proven leadership to drive effective communication, coordination, and collaboration across cross-functional groups
Ability to interface with all levels of the organization, including Manufacturing, Quality, MSAT, QC, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, and EH&S
Experience in a fast-paced, mission-driven environment
Ability to operate in a controlled GMP environment and perform gowning as per procedure
Ability to perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
Ability to execute manufacturing processes in both R&D and GMP environments, following protocols and/or SOPs
Understanding of all operations, functions, capability of equipment and ancillary support, with ability to operate equipment and perform complex troubleshooting
Knowledge of compliance and regulatory requirements, current Good Manufacturing Practices (cGMPs), and the rationale behind regulations
Ability to coach and mentor others on compliance

Responsibilities

Lead, direct, coach, and develop an effective manufacturing team responsible for daily clinical and commercial/clinical production of autologous and allogeneic cell therapy products, ensuring safe and compliant operations according to cGMP requirements
Provide technical and managerial leadership by interfacing and collaborating with key stakeholders and functions to manufacture and disposition products to patients in a timely manner
Lead and oversee manufacturing processes including engineering runs, PPQ, and APS
Ensure manufacturing processes in R&D and GMP environments follow appropriate protocols and/or SOPs
Responsible for on-the-floor operation performance, aseptic technique, process execution, and compliance with standards
Make spot corrections and provide feedback on process and procedure adherence to employees in the cleanroom
Review in-process and completed documents for accuracy, including SAP issuance of materials, and ensure documentation is turned in within specified days
Initiate, investigate, and support closure of Deviation Reports, CAPAs, and Change Controls
Revise and originate production records, SOPs, protocols, and reports
Accountable for schedule preparation, adjustments, and performance of work assignments for the team
Coordinate and perform routine cleanroom and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
Oversee hiring, development, and performance management of staff
Train and mentor new manufacturing associates on procedures, aseptic techniques, equipment, and troubleshooting skills
Ensure team’s training status is compliant
Actively participate in health authority, customer, and internal audits
Work closely with other functions

Skills

cGMP

Cell Therapy Manufacturing

Autologous Cell Therapy

Allogeneic Cell Therapy

Manufacturing Leadership

SOP

PPQ

GMP

MSAT

Supply Chain

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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