60% of time Review of executed batch records, solution preparation forms, and other executed controlled GMP documents used within Manufacturing Operations. 20% of time Complete cGMP document revisions, execute CAPAs and completion of change control actions as needed. 10% of time Investigate manufacturing deviations. 10% of time Support continuous improvement initiatives w

Build the requisite project team to include key stakeholders that will support all aspects of project delivery including Safety/EHS, Project Controls, Engineering, Design, Construction, Commissioning, Qualification, and Validation. This will include overseeing the selection and contracting of the Engineering/Procurement/construction/CQV resources. Leverage Roche resources

Primary point of contact for CDMO program management. Responsible for managing the day to day deliverables associated with technology transfer execution associated with the SOW and project plans. Interfaces between the Spark technology transfer teams and the CDMO. Responsible for ensuring protocols, batch records, quality records, and other technical documents are managed

As a manager, is responsible for GTIC project related activities. Acts as an advisor to cross functional team members to meet schedules (routine Manufacturing and/or special projects) and resolve technical or operational concerns. Directs, prioritizes, and coordinates the daily activities of the GTIC Validation staff for new (start up) utilities, process, and support equi

Lead a team of scientists initiating and developing discovery programs through to preclinical development. Mentor and develop staff. Ensure individual goals and objectives are aligned to departmental and organizational goals and objectives. Devise and evaluate novel strategies to address limitations of current non viral gene therapy approaches through novel design, engine

Advise and provide legal guidance to support business initiatives for stakeholders in the patient supply organization and other business functions in a manner that advances the company's strategy, addresses legal/regulatory risks and maintains the company's integrity and reputation. Provide transactional support for manufacturing, supply, logistics, real estate, facilitie

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 unlock the power of gene therapy to accelerate healthcare transformation. We don't follow footsteps. We create the path. The Attending Veterinarian will be responsible for the operations of S

% of Time Job Function and Description 25% Serve as company SME for CDx strategy and knowledge, working to embed precision medicine principles in the Spark development culture 25% Assemble and lead cross functional (bioanalytical, regulatory, quality, commercial) teams supporting the strategic and technical development of CDx for Spark gene therapy assets. Partner with re

As a key member of the Development SubTeam (DevST), the incumbent will be responsible for implementing the Clinical Development Plan (CDP) for assigned programs to include Collaborating with cross functional project team members in planning, conducting and evaluating clinical trials for assigned programmes. This includes being responsible for the preparation and review of

(to include but not limited to) Job Function and Description Provide oversight for the governance, management and coordination of activities related to the data integrity including implementing and maintaining data integrity compliance activities across the end to end product lifecycle and across all internal functions in alignment with relevant governmental regulations an

Rotational 2 year post PharmD industry fellowship Goal To gain work experience within biotechnology industry and a thorough understanding of rare conditions while collaborating cross functionally as an integral member of the Medical Affairs team. This unique opportunity will prepare the candidates for a position within Medical Affairs, such as an in house role within Medi

50% of time Implement the GCP / GVP quality strategy for Spark Therapeutics' gene therapy assets Define, implement, and optimize risk based quality management plans for clinical assets Provide global GCP and GVP guidance for cross functional development teams inclusive of the review of critical documents (e.g., study protocols, investigator's brochure, periodic reports) S

55% of time Assumes responsibility for strategic planning, execution, and reporting of research work in alignment with the Ocular therapeutic area 20% of time In the partnership with ocular program development teams, supports immunogenicity risk assessment, preclinical and clinical immunomonitoring design and interpretation of the clinical immune readouts. 5% of time Over

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 unlock the power of gene therapy to accelerate healthcare transformation. We don't follow footsteps. We create the path. The Alliance Management Operations Specialist will work closely with t

reports. Responsibilities Job Function and Description Participate in and lead operational excellence activities, including but not limited to GEMBA walks, safety inspections and self inspections, 5S exercises, visual boards, Kaizen. Assist with data collection for departmental metrics and reporting of metrics to department management and the manufacturing team. Administr