Manufacturing Science and Technology Tech Transfer Scientist/Process Engineer
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania
- Salary
- Salary not provided
- Closing date
- Feb 17, 2022
View more
- Discipline
- Physical Sciences, Engineering, Health Sciences, Drug Development, Other, Manufacturing/QA/QC
- Job Type
- Staff Scientist
- Organization Type
- Biotech
Job Details
- Translation of process requirements from source documents into tech transfer (sending) requirements into protocols and batch records (receiving)
- Identification and technical review of alternative materials and consumables relative to process requirements.
- Review of executed GLP & GMP manufacturing records
- Participate in daily tech transfer meetings as scribe, SME and action owner.
- Process scale up, support and trouble shooting
- investigation support to close deviations (non-conformance)
- During the manufacturing preparation phase, this role will lead delivery of pre-run deliverables such as Materials List, Process Transfer Documents, NORs and Targets for process control parameters in the Manufacturing Batch Records, Process Monitoring plans, etc. To meet these deliverables the MS&T lab will both generate data and compile data from external sources, e.g. CDMOs, CMOs.
- During the manufacturing execution phase, lead selected manufacturing investigations related to product impact, change control justifications, and implementation related to process and equipment adequacy and efficiency, process monitoring, and general troubleshooting.
- During the Campaign Close-out phase, complete investigations, auxiliary studies and data analysis to ensure timely product disposition. In addition, contribute to playbooks in anticipation of regular Agency and Partner interactions.
- Throughout all phases, this position will execute Root Cause Analysis, as well as drive continuous improvement and process improvement opportunities.
- Write, Review deviations pertaining to manufacturing processes and perform product impact assessments for facility, and raw material deviations.
- Design process characterization protocols as needed, and oversee that Process Monitoring regulatory requirements are being met.
- Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments in preparation for GMP Manufacturing
- Approvals of any Manufacturing Change Controls, Validation protocols, and CAPAs, collaborate with Manufacturing on CAPA effectiveness.
- As needed, be present at CMOs & CDMOs to monitor execution of production and studies, as well provide technical guidance as needed.
- Manage performance: know what is expected, what it takes to be successful, and self-monitor progress. Be accountable to achieve results while demonstrating the Spark Values. Periodically review individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
- Commit to collaborate. Be a strong team player and business partner cross functionally. Understand the development goals, strengths and motivators of your colleagues and partner to achieve mutual success and continuous improvement as well as professional development.
- Foster Spark’s Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
- BS in Life Science/Engineering or related field required.
- Minimum 2 years of experience in the Biotechnology or Pharmaceutical industry.
- Experience in biopharmaceutical based GMP manufacturing science and technology.
- Direct experience in cell culture and/or purification (downstream) in development and/or production environments.
- Proven track record of contributions to manufacturing technology platform development, in a GLP/GMP Pilot Plant and/or development lab facility.
- Demonstrated technical project management experience to develop project goals, deliverables, timelines, budget management and ongoing prioritization.
- Experience with accelerated CMC development pathways a plus
- Knowledge of GXP compliance
- The position requires knowledge and experience with cGMP upstream manufacturing of biopharmaceuticals or biologics and the life cycle management of these processes. Experience with virus or vaccine manufacturing a plus.
- Demonstrated ability to lead investigations, study execution, and produce high quality technical documentation.
- Proven ability to productively collaborate cross functionally to deliver results. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Encourages or facilitates a beneficial resolution of purpose. Resolve conflicts in a constructive manner that allows win/win solution
- Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
- Experience with data analytic tools such as SAS JMP a plus.
- Efficiently complete true root cause analysis, corrective action plan development and execution, including effectiveness verification.
- Ability to prepare contingency plans and logically work through complex technical issues in a pressure filled atmosphere
- Ensure resolution to all organizational, technical and product lifecycle management issues.
- Erroneous decisions or failure to achieve results may have significant financial implications or cause delays in schedules.
- Regular cross functional interactions internally with Process Development, Analytical Sciences, QA, QC, RA CM, PMO Functions.
- Regular cross functional interactions with external CDMP and CMO organizations
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.
Nearest Major Market: Philadelphia
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.
We don't follow footsteps. We create the path.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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