Legend Biotech is seeking a Manager, Operations Training as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Manager, Operations Training, will be responsible for managing the training team who lead training activities for the overall plant operation team members who support cGMP Commercial Cell Therapy Manufacturing. This individual will oversee the Training team members in collaboration with department management in Operations and Quality to support personalized cell therapy production through safe and compliant operations according to cGMP requirements. This individual will support the organization door to floor program and ramp-up of commercial production. The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Leads, directs, coaches and develops a holistic, effective training program for all plant functions and personnel that support daily commercial production.
• Manages training team to plan, coordinate, prepare and deploy training curriculum.
• Perform training assessments for new and updated procedures.
• Oversee and schedule training skill checks and qualifications.
• Support evaluation of appropriate compliance courses.
• Leads and works with training team to manage training requirements for new hires.
• Work collaboratively with functional leads for procedure alignment based on roles.
• Serve as subject matter expert for Compliance & Training systems.
• Oversees onboarding for all new manufacturing operators.
• Knowledge of LMS system.
• Maintain and report quality training metrics.
• Prepares information for internal and external audits.
• Ensure productivity, timeliness, and quality of Change Controls and CAPA implementation.

Requirements

• A minimum of a Bachelor’s Degree in Science; advanced degree preferred.
• A minimum of 5-8 years relevant work and management experience is required. It is preferable that the candidate have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• 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.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Ability to effectively prioritize and execute tasks in a fast-paced environment.
• Works well in a team-oriented, collaborative environment.
• Demonstrated track record of driving continuous improvement initiatives.
• Proven leadership and team management skills.

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Legend Biotech is seeking a Sr. CQV Specialist as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV experience, represent CQV work in the regulator and internal audits, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.

Key Responsibilities

• Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
• Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Supports and/or owns technical and quality investigations, CAPAs and corrections.
• Develops and performs any required remediation efforts and associated CAPA plans.
• Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
• Train and support the junior team members on different CQV activities.
• Present CQV work to regulatory and internal audit teams.
• Other responsibilities as assigned.
• Making decision on corrective action in deviation events.
• Make decisions on technical approach, methodology per applicable procedure.
• Manager approval required for resource assignment, timeline shift, strategic shift and finance related events. 

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 7 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
• Ability to use following or similar systems for business needs: Microsoft suite & ERP systems: Maximo, Siemens EMS, Comet, Kneat & Testing system: Kaye AVS, Kaye Valprobe.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Ability to work with others in a team environment.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols. 

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About ProBio:

 ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017

Job Scope

The Senior Manager, Quality Operations is responsible for Manufacturing & QC Shop-Floor Quality, Batch Release, Document Control, and Training functions. He /She oversees the group responsible for quality functions related to Good Manufacturing Practices (GMP) and Phase-Appropriate compliance for both clinical and marketed Gene Therapy products and Plasmid DNA at the Hopewell manufacturing facility. He /She is expected to grow and develop the group commensurate with the business need.

Essential Responsibilities:

Lead Probio Quality Operations and Batch Release Program for Gene Therapy and Plasmid Manufacturing. This may include, but may not be limited to the following functions:

• Develops procedures for and performs local batch disposition for Gene Therapy Drug Substance, Drug Product, MCB (Master Cell Bank), Plasmid and Finished goods manufactured at the Hopewell, NJ site.
• Issues batch compliance documentation such as Certificates of Conformance/ Compliance / Quality (CoCs/COQs), Certificates of Analysis (CoAs), BSE/TSE Statements.
• Develops and manages QA functions related to Cell Bank and Plasmid disposition, usage, and lifecycle.
• Oversees ProBio QA Area Release/ Line Clearance Procedures and facility walkthroughs.
• Oversees the QA approval of calibration reports for GMP equipment/instruments in Maximo
• Supports internal and external audits to assure compliance with GMP regulations.
• Manages or performs QA “person-in-plant” type activities during cell bank receipt, manufacturing, filling, labeling, visual inspection, packaging, warehousing and shipping activities.

Directs Document Control, Records Management & training activities for the Gene Therapy Manufacturing Site Activities. This may include, but may not be limited to the following functions:

• Oversees Document control activities related to approval of local electronic documents such as SOPs, Standards, Forms, Work Instructions, Master Batch Records, and specifications.
• Develops and implements local procedures for control of drug product label proofs, printed labels, and reconciliation of unused/damaged labels.
• Manage Veeva Vault administration for all Veeva Vault applications.
• Supports interactions with regulatory authorities related to manufacturing quality and compliance policies, guidelines, and systems.
• Recommends Quality system changes to enhance overall job performance and Quality functions and partners with peers in overseeing the implementation of these changes.

Qualifications:

• Bachelor’s degree in a scientific discipline and a minimum 7 years of experience in Quality or related role(s) in a pharmaceutical, biotechnology or related environment, and at least 3 of which have been in a CMC-focused Quality position.
• Experience with Veeva Vault Quality Docs and Training
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Demonstrated knowledge of biologics, viral vector, and plasmid manufacturing and testing.        

The Pay range is estimated between $110000 - $150000, based on experience and skill set

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Seeking talent near: Princeton, NJ; San Diego, CA

Position Summary:

Responsible for coordination of packaging (package design), artwork, and serialization with commercial Drug Product Contract Manufacturing organizations (CMO’s), and other third party suppliers for products as identified. Subject matter expert in the field of serialization to oversee our CMOs running commercial and Acadia data management and integration.

Experienced in the technical aspects of product introduction into the EU and other global markets as related to serialization, package design, and local requirements.

Primary Responsibilities:

• Develops and maintains good working relationships with both internal stakeholders and contract manufacturers.
• Acquires and maintains scientific and technological knowledge and background of existing and new pharmaceutical (surface) serialization technologies to ensure our CMOs are aligned. Verifies CMO serialization technologies and ensures compliance with pharmaceutical regulatory requirements (EU FMD and DSCSA).
• Coordinate periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.
• Maintains and follow through a consolidated Acadia Manufacturing action log to ensure all manufacturing related actions are completed on time.
• Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings.
• Works with Quality Group and Acadia Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
• With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
• Provide onsite process coverage as person-in-plant as needed
• Develops, collects appropriate internal and external metrics to measure CMO and Acadia performance.
• Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.
• Supervise, train and mentor personnel as needed.

Education/Experience/Skills:

BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience.  Scientific advanced degree a plus.  A minimum of 8 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.

Must possess:

• Contract service provider experience.
• Strong understanding is required of the biopharmaceutical serialization and packaging process
• Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
• Extensive knowledge of current Good Manufacturing Practices (cGMPs)
• Able to operate effectively and with a strong sense of urgency in a fast-paced environment.
• Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
• Domestic and International travel is required for this role.
• Experience in a cGMP environment
• Capability to communicate efficiently and effective about issues of a complex (technological and scientific) nature
• Attention for detail

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.   Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.

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