Senior Engineer/Principal Engineer, External Manufacturing “Person-in-Plant” (BB-4C37F)
Trouvé dans: Neuvoo BE
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
We are seeking a Senior Engineer/Principal Engineer to fill a pivotal role in managing our contract manufacturers in a ‘Person-in-Plant’ role.
The successful candidate will interface with Contract Development and Manufacturing Organizations (CDMOs) that are part of our supply chain and primarily oversee activities related to GMP manufacture of our gene edited autologous drug products. The ideal candidate has deep early and late-stage process development experience, experience with transferring processes to Manufacturing and interfacing with in-house and/or external Manufacturing organizations. Experience with cell therapy manufacturing and process development, risk analysis, investigation methodologies, change control systems and related QA documentation is a plus.
- Provide scientific and technical support to CDMOs, particularly related to development and GMP manufacturing of gene-edited allogeneic cell therapy drug products.
- Handle multiple clinical to commercial stage programs at CDMOs, provide person-in-plant support and regularly interface with internal program teams and teams at the CDMO to ensure seamless delivery of the production or project plan.
- Support tech transfer activities as appropriate.
- Develop and communicate clear technical plans both for laboratory studies and scale-up and cGMP manufacturing scopes of work at CDMOs. Drive relationship with CDMO, oversee timely and effective closure of investigations and implementation of CAPAs, review of MBRs and batch disposition.
- Review CDMO documentation in a timely and effective fashion including MBRs, sampling plans, milestone reports, investigation/incident documentation, change control documentation and others to enable successful manufacturing of CRISPR’s product portfolio.
- Provide leadership during technical troubleshooting of manufacturing and testing issues, both in-house and at CDMOs. This will require leadership strong experience in root cause analysis and risk assessments.
- Participate in program teams as an SME and manufacturing expert. Maintain and communicate CDMO timelines and plans to enable creation of a program level integrated project view.
- Support strategic internal and external collaborators and suppliers.
- Support authoring and generation of CMC sections for regulatory filings (INDs, BLAs, etc).
- Support preparation, planning and support for process performance qualification (PPQ) activities as well as necessary scale-down validation and supporting studies to help prepare the filing package for commercial launch. Oversee CDMO’s progress towards a Master Validation Plan to enable successful commercialization of CRISPR’s product portfolio.
- Interface with Process and Analytical Development teams to understand process operations and key processing steps to enable successful technology transfer to CDMOs.
- Be a champion of a highly collaborate, transparent, data driven, ‘make it happen’, culture.
- BS/MS in Chemical/Biochemical Engineering or related discipline (e.g. Chemistry/Biochemistry), and Sr. Engineer with 5 or more years of industrial experience in the development and manufacturing of biopharmaceuticals for example proteins, vaccines, and/or cell and gene therapy products.
- Excellent knowledge of cell and gene therapy and/or biologics process development and manufacturing with tech transfer, scale-up and clinical/commercial manufacturing.
- Comprehensive knowledge of GMP, aseptic processing, ATMP requirements
- Has been involved in the development and scale-up of multiple products across different product lines, reflecting a breadth of understanding of cell culture process requirements.
- Experience in working with CDMOs and third parties for process development and cGMP manufacturing.
- Ability to effectively communicate and collaborate with internal and external stakeholders is essential.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute program timelines and follow-through to completion, including diligent follow up on action items/next steps, removing barriers, communicating risks, etc.
- Self-driven, independently motivated, data driven and excellent problem-solving ability.
- Fluent in English and French
- Gosselies, Belgium based, available to travel internationally.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
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