Manufacturing Lead Operator, Aseptic Process

BioSpace; Raritan (NJ); Sur place; USD 84 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Résumé du poste

Legend Biotech, based in Bridgewater, NJ, seeks a Manufacturing Lead Operator, Aseptic Process for the Manufacturing & Operations team in Raritan. This role supports CAR-T cell therapy production in ISO 5 and ISO 7 cleanrooms, performing unit operations and ensuring cGMP compliance on a fast-paced production floor.

You will work with Engineering and Quality groups, apply robust aseptic techniques, manage batch records, and participate in continuous improvement, troubleshooting, and change

Qualifications

• Bachelor's degree in life science/engineering or related field.
• Minimum of 2 years of operations experience in a cGMP biotech environment.
• Experience with aseptic manufacturing and batch records is preferred.

Responsabilités

• Perform core manufacturing unit operations (cell culture, purification, aseptic processing, cryopreservation).
• Maintain batch records and production data with accuracy and clarity.
• Support continuous improvement and change control activities.

Connaissances

Engineering degree

CAR-T knowledge

cGMP experience

Formation

Bachelor's degree in life science/engineering

Outils

ISO 5/ISO 7 cleanroom

Description du poste

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Manufacturing Lead Operator, Aseptic Process as part of the Manufacturing & Operations team based in Raritan, NJ.

Role Overview

CAR-T products and processes are a novel cell therapy, and thus are well supported by a degree in engineering or a related field where not only are valuable scientific and technical skills learned, but also the ability to connect ideas and analyze complex problems. This role will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule.

Key Responsibilities

This individual establishes effective time management skills and prioritization of various job requirements, supported by a degree in engineering or related field to better analyze and execute effective decision during critical times for positive outcomes.

To offer support in development of CAR-T manufacturing processes, this individual requires an understanding of the underlying technical requirements of the process and product must have, where complex risk analyses and change management techniques are utilized to establish a high quality and safe drug product through periods of improvement.

This individual with strong scientific and technical background, will support the development of manufacturing processes, and will work with technical support and engineering personnel to drive continuous improvements and implement corrective and preventative actions within cell therapy Technical Operations.

This individual will be responsible for general production floor oversight of Legend Biotech's BCMA CAR-T Cell Therapy Operations in both ISO 5 and ISO 7 environments, and support floor activities with extensive knowledge of CAR-T cell therapy processes, GMP quality systems and their regulatory requirements.

This individual requires prior in-depth knowledge of lab sciences, cellular lab techniques, and data analysis to complete daily responsibilities and assess the impacts and consequences in relation to other process areas, without jeopardizing quality, accuracy and efficiency.

This individual will perform process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) performed within specialized BSL2+ ISO 5 and ISO 7 cleanroom environments, according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.

This individual will require critical thinking and troubleshooting skills to respond to patient specific product issues to ensure continuous flow of operations, while performing tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements within particular manufacturing processes.

Establish key stakeholder relationships with internal and external stakeholders, as collaboration and understanding across functional stakeholders are essential to maintaining this dynamic, fast-paced environment, which is CAR-T manufacturing

With a degree in engineering and related scientific or technical field, this individual must have the ability to interact with all levels within the organization through scientific and technical expertise

Strong communicative skills and a broad technical understanding of complex systems are must haves, to build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional and matrixed team to successful manufacture CAR-T product in a safe and high quality manner.

Requirements

Bachelor's degree in life science/engineering, or related field or equivalent experience required.

A minimum of 2 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, maintenance, quality, testing, or engineering is required. Prior experience in an aseptic manufacturing environment is preferred.

An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.

Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.

Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.

Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.

Ability to lift a minimum of 50 lbs and stand for a long period of time.

Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records.

Ability to handle human derived materials in BSL-2 cleanroom facility.

Physical dexterity sufficient to use computers and documentation.

Ability to accommodate shift work including evenings and weekends as required by the manufacturing process.

Ability to accommodate unplanned overtime on little to no prior notice.

Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicalsDistance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.

Color Perception both eyes 5 slides out of 8.

AI Literacy: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay)

$83,711 - $109,870 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.