Senior Director, IDMO Site Quality at Cellares

Bridgewater, New Jersey, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

Bachelor's degree in science, engineering, or related field required
10+ years of Quality Management experience within a cGMP environment in the biotech/biopharma industry
Minimum of 5 years of senior leadership experience
Cell/Gene Therapy and CDMO experience preferred
Work effectively with US FDA and other regulatory agencies
Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards
Proven experience implementing continuous improvement initiatives to drive Quality programs and ensure maximum productivity
Ensure Quality systems meet the needs of all internal and external stakeholders with an emphasis on process, quality, productivity, budget control, and profitability
Past experience developing, implementing, and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines
Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels, and regulatory authority interaction
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
History of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization

Responsibilities

Lead, direct, coach, and develop an effective QA and QC team responsible for daily clinical and commercial production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements
Provide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely manner
Oversee the hiring, development, and performance management of staff within QA and QC
Develop a Quality Culture and compliance related manufacturing and process controls to improve quality systems
Establish critical KPIs, monitor progress and keep critical stakeholders informed of progress
Lead and actively participate in all regulatory and internal audits of the facility
Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
Establish key stakeholder relationships with internal and external stakeholders

Skills

cGMP

QMS

Cell Therapy

Manufacturing

Regulatory Compliance

GMP Operations

Quality Assurance

Quality Control

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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