JOB SUMMARY

Responsible for driving all aspects of the Analytical and Microbiological Quality Control (QC) laboratories at Genezen. This individual provides leadership, scientific and technical expertise for all QC activities, as well as support to Analytical Development for all method qualification/validation activities. This person is also the facility aseptic subject matter expert, including responsibilities for the environmental monitoring program. The ideal candidate must have in-depth knowledge and experience in a cGMP/ GLP testing lab.

ESSENTIAL JOB FUNCTIONS

• Ensure timely in-process and release testing of early clinical grade biopharmaceuticals
• Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, and cell-based assays)
• Monitor, maintain and continuously improve the environmental monitoring program, including conducting Environmental Monitoring Performance Qualifications as needed
• Develop, implement and maintain EM trending program and metrics, including Annual Reports and evaluation of alert levels
• Develop, implement and maintain an in-house isolates program
• Responsible for Disinfectant Efficacy Program
• Responsible for the Analytical laboratory equipment systems and software (e.g., ddPCR, Flow, etc.) including purchase, calibration, IOPQ activities, etc. to meet the compliance (data integrity) requirements and project timelines.
• Support the Analytical Development team in qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
• Support the tech transfer of bioassays from clients to cGMP QC testing lab
• Represent QC Analytical and Microbiological in client meetings and programs
• Establish and maintain the stability program
• Oversee LIMS development, implementation, operation, troubleshooting and maintenance
• Responsible for all laboratory logistics activities including, but not limited to sample management, test/release schedule, cycle time matrix, capacity management, etc.
• Manage outside contract laboratory relationships, including method qualification/validations, investigations, audits, cost and invoices to meet project timelines and business requirements
• Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
• Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of cell and gene products
• Develop, implement and present metrics for monitoring of lab operations and stability program
• Participation in client audits and regulatory inspections as SME and development of responses to observations
• Responsible for hiring and development of team members, conduct performance review and disciplinary actions.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area

 KNOWLEDGE, SKILLS, AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

•  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

PURPOSE

Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

ESSENTIAL JOB FUNCTIONS / DUTIES

• Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
• Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
• Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
• Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
• Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
• Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
• Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications.
• Review, assess, and release quality control tests and Certificates of Analysis
• Review and approve executed batch records. Provide guidance and support to departments on errors to ensure error reduction.
• Assist in the final disposition of master cell banks and viral vector products.
• Review and approve qualification/validation protocols and reports and technology transfer reports.
• Provides site GMP and GDP training (annually, for new-hires, and as needed).
• Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events.
• Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
• Drive Quality Events to closure within on-time closure deadlines.
• Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products,
• Review and approve Master Batch Records.
• Review and approve Media Fill Protocols and Reports, as well as participate as a Quality observer as needed.
• Review and approve Stability Protocols.
• Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas
• Initiate, review, approve and monitor Change Management activities
• Work with the other functional areas to give guidance on use of quality systems.
• Assist the Lead Auditors to perform site internal audits.
• Lead and/or support customer audits and regulatory inspections by participating in either front or back room.
• Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Occasionally exposed to loud noise levels
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

Provide maintenance, calibration, and technical support to the manufacturing process and facility equipment.  Coordinate and perform testing and calibration on electrical, mechanical, and analytical equipment for conformance to established standards. Request purchase order requisitions for 3^rd party maintenance requirements.

ESSENTIAL JOB FUNCTIONS

• Assist in creating/establishing a Maintenance and Calibration Program including recommendation of Maintenance and Calibration activities and frequencies based upon system/equipment assessments
• Plan, schedule, and perform planned and unplanned maintenance and calibration on process and facility equipment/utilities including but not limited to HVAC, freezers, cold rooms, bioreactors, filling systems, analytical testing instruments, and building management control systems
• Coordinate and support external calibration service providers
• Build relationships with customers, colleagues, and service partners to provide a collaborative approach to the operational management of lab spaces.
• Track and report on calibration status of all equipment/instruments in the facility
• Ensure timely completion of calibrations/preventive maintenance and compliant record keeping.
• Obtain required documentation and approval prior to creation of purchase order requisition for service requests to be completed by 3^rd party vendors.
• After purchase order has been issued, ensure service delivery dates are correct and revise as necessary, per follow-up with suppliers and customers.
• Source, qualify, negotiate, and procure service contracts in support of lab operations.
• Ensure purchase requisitions are requisitions closed within 180 days and confirm that associated purchase orders are closed as well.
• Enter and maintain records in the Computerized Maintenance Management System (CMMS)
• Meet regularly with key stakeholders (lab staff, service partners, management) to identify, review and resolve issues in a timely manner and/or escalate as necessary.
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

• Associates Degree
• Bachelor's degree 
• EET
• 3-5 years related Calibration/Metrology work experience
• Ability to understand user manuals/specifications, wiring diagrams, equipment Piping & Instrumentation Diagrams (P&ID), and Standard Operating Procedures (SOP)
• Mechanically inclined/knowledge of hand tools
• Proficient with advanced computer systems including the use of a CMMS
• Excellent interpersonal skills and communication skills with ability to act as a change agent

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication 

• Frequently required to communicate by talking, hearing, using telephone and e-mail