The Sterility Assurance Lead is a critical member of the Quality Control & Analytical Sciences team. This role serves as the SME for Sterility Assurance topics including but not limited to aseptic process simulation (APS), EM isolate program, gowning and aseptic qualifications, disinfectant efficacy program, viral inactivation studies, utility sampling, and excursion investigations. She/he will be responsible for:
- Day to day oversight and operations of the QC Environmental Monitoring Program at Spark Therapeutics, Inc. to support Technical Operations (Quality Control, Facilities and Manufacturing) and Quality Assurance.
- Authoring and supporting regulatory submissions and responses, maintaining audit readiness of the EM program, and participating in audit activities.
- Serving as the point of contact for CMO and CTL partners that maintain clean rooms, utilities, and EM programs in support for Spark products.
- Authoring and reviewing SOP’s, Technical Documents, Technical Protocols and Reports for the Technical Development and Operations team.
- Developing contamination control program and associated risk assessments for new facility and products.
- Developing and maintaining a disinfectant efficacy program.
- Supporting cycle development and qualification of utilities and systems requiring biological indicator challenges.
- Leading EM excursion investigations and determining root cause and appropriate corrective actions.
- Reviewing data, trend reporting, and presenting EM Program metrics at Quality Management Review.
- Following all EH&S safety requirements for site and QC laboratories and manufacturing spaces.
- Additional responsibilities will include:
- EM Program development, planning, and implementation for the new Gene Therapy Innovation Center (GTIC).
- Routine surveillance of current guidelines and regulatory opinion to identify potential gaps and develop strategy to address any gaps appropriately to ensure compliance of the EM Program.
- Oversight of the EM program at Spark’s 3737 facility, excursion investigations, and trend reports.
- Foster Sparks Culture and lead by example. Create an environment where team members thrive in Spark’s culture by living our truths, always in compliance with applicable laws and regulations. Demonstrate to team members that how they achieve performance objectives is just as important as hat they accomplish.
- Working with the GTIC team and consulting with the QC Microbiological Control and Compendial Testing Leader in the planning and establishment of an EM program at GTIC, including recommendations for equipment and process.
- Generate policies and procedures related to the EM Program including surface, viable air, non-viable particulate, and any other testing required by USP/EP/JP as applicable
- Lead non-conformance investigations, risk assessments, and other required QA documentation related to the EM program.
- Generate reporting of metrics and quarterly trending.
- Support QC Microbiological Control and Compendial Testing Leader during Management Review and operational meetings.
- Support and review of regulatory submissions.
- Support Spark during audits and regulatory submissions.
- Routine surveillance of current guidelines and regulatory opinion.
Education and Experience Requirements
- BS or MS degree required, in the biological or chemical sciences preferred.
- 10 years of related experience in the Bio/Pharmaceutical industry with biopharmaceutical products, biologics or vaccines required, including demonstrated experience with APS.
- Demonstrated strong working knowledge of GMP manufacturing.
- Demonstrated broad working knowledge and experience of regulatory guidance and industry best practice quality control.
- Leading and supporting investigations and making decisions around issues that arise in the facility, laboratory, and manufacturing related to the area of responsibility.
- Trend monitoring and reporting.
Key Skills, Abilities, and Competencies
- Hands on experience and demonstrated technical knowledge of environmental monitoring of classified clean rooms and utilities sampling, including new site planning, commissioning, and qualification activities.
- Independent decision maker using technical knowledge, skills, and experience to develop solutions to a variety of problems of high complexity, exercising judgment within defined procedures and practices to determine appropriate action or escalation.
- Interprets and understands environmental monitoring data and potential impact to environment and product
- Exceptional written and verbal communication and interpersonal skills within the QC department and cross functionally
- Uses sound judgement regarding complex issues and escalates when necessary
- Trains new staff within immediate team and other cross functional teams
- Mentors and couches junior team members and assists in development planning
- Ability to build productive working relationships internally and externally
- Ability to work with limited supervision
- Ability to interpret regulatory guidance and assess against current industry best-practice to develop policies and procedures.
Complexity and Problem Solving
This position requires advanced experience and knowledge of regulatory guidance and industry best practice in sterility assurance, including environmental monitoring, to establish policies and procedures. Proactive identification of potential product and environmental issues and communication of solutions/recommendations to site management is imperative.
It is also expected to identify potential regulatory concerns and assess risk from routine analysis of sample data, deviations, and excursions, as well as audits and review of information from laboratory service providers. The employee supports investigations and assists the QC Microbiological Contamination and Compendial Testing Leader to make decisions around issues that arise in the facility, laboratory, and manufacturing related to the area of responsibility
This job advises the QC Microbiological Contamination and Compendial Testing Leader and Head of Quality Control & Analytical Sciences on matters related to facility impacts to the EM Program.
This job works directly with the GTIC team to develop an environmental and utility monitoring program for a new construction.
The job supports the CMDOs and CTLs in all Sterility Assurance matters.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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