- Lilly (Lebanon, IN)
- …operations._ **OVERVIEW:** Main Purpose and Objectives of Position: The Senior Director Quality is directly responsible for providing technical understanding ... quality objectives, priorities, and roadmap. The QA Senior Director leads and/or participates in the assessment, development, and...controls, testing, and monitoring are carried out with the quality control function in accordance with the… more
- Kelly Services (Burlington, MA)
- **Sr. Manager/ Associate Director - Quality Assurance** **Burlington, MA** **Direct Hire** **Compensation: $125k-165k base + 10-15% annual bonus** **Candidate ... an experienced QA professional to support and evolve the quality management systems and processes at our US Site...serving leading pharma in biologic development and cell & gene therapy. This is a unique opportunity to join… more
- Editas Medicine (Cambridge, MA)
- …and Analytical Development, Internal and External Manufacturing, Validation and Metrology, Quality Control and Analytical Technologies (QCAT), Quality ... allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at the core of everything we do,… more
- University of Southern California (Los Angeles, CA)
- …development and support the transfer of processes to cGMP manufacturing and quality control . + develops and reviews standard operating procedures, protocols, ... and support to effectively carry out projects. + Offers training to manufacturing and quality control teams during the tech transfer process. + Designs and… more
- Sumitomo Pharma (Morrisville, NC)
- **Sr. Director , Cell Quality ** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need ... oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed...motivated, and experienced individual for the position of Sr. Director , Cell Quality . The Sr. Director… more
- Lilly (Indianapolis, IN)
- …+ Demonstrated experience in elucidating mechanism of action of molecules, understanding gene expression control , signal transduction pathways in fields on ... insulins, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, peptides and gene therapy systems. This organization is a multidisciplinary group that… more
- Bristol Myers Squibb (Bothell, WA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Quality Assurance (QA) Associate Director (AD) will be responsible for ... including Quality review and approval of document changes, deviations, change control assessments, and Quality risk management assessments. The QA AD has… more
- Catalent Pharma Solutions (Harmans, MD)
- …externally developed processes. + Works cross functionally with process development, manufacturing, quality assurance, quality control , supply chain, and ... **Job Title: Director , Manufacturing Sciences & Technology (MS&T)** **Location: Harmans,...the facility fit and technical transfer of mammalian, microbial, Gene and Cell Therapy and viral vector biologic processes,… more
- Astellas Pharma (Westborough, MA)
- …act as subject matter expert (SME) for manufacturing operations + Join forces with Quality Assurance, Validation, and Quality Control to maintain the ... ** Director , Manufacturing Operations** Do you want to be...as required to enable timely and compliant release of quality material that meets all release requirements. + Partner… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …of Advanced Therapies industry such as product development, R&D, project management, quality control and regulatory. + Experience in large biomedical industries ... School of Medicine (Atlanta, GA), invites applications for a **faculty program director ** of the newly formed Masters of Biomedical Innovation and Development… more
- Lilly (Lebanon, IN)
- …development, review, approval, and delivery of training meet corporate and site quality standards. Additionally, the Associate Director will oversee performance ... constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. Located in Lebanon, Indiana, this facility, Lebanon Plant 2 (LP2),… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …of Advanced Therapies industry such as product development, R&D, project management, quality control and regulatory. + Experience in large biomedical industries, ... excellence of our academic community. **Description** JOB DESCRIPTION: + The Director Masters of Biomedical Innovation and Development in Advance Therapeutics, will… more
- Beth Israel Lahey Health (Boston, MA)
- …team will support researchers across the research community with their data management, quality control , analysis of data and presentation of results and will ... does not intimidate you. **Job Description:** **Job Summary:** The Bioinformatics Core Director will have strategic and tactical responsibility for the operations of… more
- Lilly (Indianapolis, IN)
- …laboratory experience + Hand-on experience in process characterization and crafting manufacturing control strategy for emerging modalities such as gene therapy ... monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy modalities. This organization is a multidisciplinary group… more
- Sanofi Group (Cambridge, MA)
- …help patients improve their quality of life by empowering them to take control of their disease. Our specific mission is to support the Sanofi business units and ... such as In-vitro diagnostics, IV at home, and targeted delivery systems for Gene therapy. The successful candidate will be responsible for leading and coordinating… more
- Alaka'ina Foundation Family of Companies (Fort Detrick, MD)
- …BSL-4 after attaining independent access. REQUIRED SKILLS AND EXPERIENCE: + Working knowledge of quality assurance and quality control systems, such as Good ... Molecular Virology Associate Study Director Location MD - Fort Detrick Job Code...(eg, viral pseudotyping, VLPs, minigenome and budding systems) + Gene knock-in/knock-out studies + Mechanisms-of-action studies + Enzymatic assays… more
- Astellas Pharma (Sanford, NC)
- …Process Sciences, Regulatory, CMC teams, Facilities, Validation, Supply Chain, Quality Control , and various vendors. **Responsibilities:** + Responsible ... please visit our website at **www.astellas.com** . **About Astellas Gene Therapies** Astellas Gene Therapies is an...supply of materials at the phase appropriate level of quality and grade + Drive risk assessments as required… more
- Sumitomo Pharma (Columbus, OH)
- **Executive Director , Commercial Supply Chain** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical ... & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a… more
- Lilly (Indianapolis, IN)
- …in Oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in ... for use in clinical trial manufacturing. + Lead to develop manufacturing process control strategies for clinical and commercial products. + Lead the preparation of… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …induced pluripotent stem cells, epigenetic and transcriptional regulation of gene expression + Hematopoietic stem cell transplantation: reduced toxicity ... immunology and immune modulation, mechanisms controlling engraftment and rejection + Therapeutic gene manipulation: gene addition, gene editing, fetal… more