- Latitude Inc. (Rockville, MD)
- …and experienced Director of Manufacturing Operations to help build our GMP manufacturing organization. This individual will be a key member of the manufacturing ... in cell and gene therapy operations. 10+ years of experience managing people in technical GMP roles. Experience in senior technical roles within a GMP … more
- AstraZeneca (Gaithersburg, MD)
- …the Associate Director of Engineering Technical Services supporting both GMP clinical manufacturing and non- GMP development scale-up manufacturing. This ... Owns and executes Quality and Safety CAPAs. Performs complex GMP change control activities. Senior Engineers may...Instructs staff on process systems and operation. Supports ETS training and the ETS apprentice program. Mentors more junior… more
- PureTech Health (Boston, MA)
- Labs and Corporate Offices 6 Tide Street Boston, MA 02210 Senior Director / Director Quality Assurance The Senior Director / Director of Quality ... Critical Quality Events, etc. Establish and maintain adequate and appropriate GMP , GCP and GLP training programs for the Company Oversee the planning and conduct… more
- MyoKardia, Inc. (Brisbane, CA)
- SUMMARY: The Senior Director , Quality Assurance will be accountable for maintaining the QA Operations and Quality Systems functions at MyoKardia. This team will ... be responsible for managing all aspects of Quality Assurance GMP compliance from drug process development through commercialization. This leader will maintain &… more
- Global Blood Therapeutics (San Francisco, CA)
- SENIOR DIRECTOR , REGULATORY AFFAIRS CMC Position Summary: The Senior Director Regulatory Affairs CMC will report to the Vice President Regulatory Affairs ... defined timelines Lead regulatory CMC intelligence activities and provide counsel, training , and interpretation of FDA and other health authority feedback, policies… more
- Decibel Therapeutics (Boston, MA)
- Senior Scientistassociate Director Aav Biology And Production - Decibel Therapeutics Description:Decibel is seeking a qualified scientist with extensive ... and downstream purification methods.* Strong leadership skills and history of training and mentoring junior scientists to create an effective and collaborative… more
- Nektar Therapeutics (San Francisco, CA)
- …to the business in the development of promotional materials and the training of product representatives. Oversees and performs medical monitoring. Drives the ... have responsibility for internal staffing and performance management, including hiring, training , coaching and performance reviews. A minimum of a Bachelors degree… more
- Lever (Redwood City, CA)
- …one field can tackle alone. We are searching for an innovative leader as Director of Quality to manage and be responsible for the Quality Assurance, Quality Control, ... position reports to the Chief Operating Officer. Must have worked in a GMP environment. What You'll Do Serve as the site Management Representative responsible for… more
- Intellia Therapeutics (Cambridge, MA)
- …and many more. We are seeking a highly motivated individual to join us as Sr. Director and Head of AAV and Cell Therapy Process Development, reporting to the SVP of ... up/scaling out manufacturing processes and transferring those processes from to GMP manufacturing. Proficiency using DOE tools A thorough understanding of quality… more
- Zymeworks Inc. (Seattle, WA)
- Director , Quality Assurance Technical & Manufacturing Operations . Seattle, Washington Zymeworks is a clinical-stage biopharmaceutical company dedicated to the ... to precisely engineer and develop highly-differentiated product candidates. Associate Director / Director , Clinical Operations is responsible for the oversight… more
- Quotient Sciences (Miami, FL)
- …qualified research participant cohorts according to protocol stipulations Works in concert with Senior Director of Operations and the Clinical Leads to provide ... in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality… more
- Miltenyi Biotec, Inc. (Sunnyvale, CA)
- …while developing a motivated, informed and efficient workforce through training , mentoring, sharing of critical underpinning knowledge and other initiatives, ... discipline and a minimum of 8 years' of direct QC experience related to GMP manufacturing in the biotechnology industry with demonstrated leadership and senior … more
- Grey Search + Strategy (Minneapolis, MN)
- …of medical products. About the opportunity The Global Regulatory and Quality Assurance Director is a strategic business partner to the Business Unit (BU) President ... and maintain records of all activities. Ensure that proper communication with senior management is maintained by coordinating periodic Management Reviews with Core… more
- Juul Labs (San Francisco, CA)
- …growing companies is compelling, read on for more details. ROLE AND RESPONSIBILITIES: The Senior Director of Pre-Clinical will be a key member of JUUL Labs ... with the expansion and maintenance of a GLP and GMP quality system Act as the project leader for...assays and in vivo pharmacology models Solid background and training in molecular, cellular biology, biochemistry toxicology or analytical… more
- Nektar Therapeutics (San Francisco, CA)
- …activities for major functional areas. Interacts internally and externally with senior level management on critical development matters that influence policymaking. ... methods, techniques and evaluation criteria for projects, programs and people. Supports Senior Management in directing the design of pivotal clinical studies for… more
- Nektar Therapeutics (San Francisco, CA)
- Position Overview The Associate Director , Clinical Operations will manage all aspects of clinical operations for assigned project(s). This includes contributing to ... interpretation of clinical programs and the data collection activities. Works with senior Clinical Operations management to establish and approve (with CRO, Program… more
- IGM Biosciences (New York, NY)
- …antibodies. Contact: Our Preclinical Sciences group is looking for a Scientist/ Senior Scientist with a strong background in Immunology, Immuno-Oncology, Pharmacology ... of a team. In this position, you will report to the Director , Antibody Pharmacology. Qualifications: PhD in Immunology/Cancer Biology/Pharmacology or a related… more
- Bachem (Vista, CA)
- …of the entire process. He/she will also be deputized to act on behalf of the Senior Director , Director , Assistant Director or Manager at Production ... of cGMP compliance at all times Assist in the training and evaluation of new hires to the required...HPLC or lyophilizers on a commercial scale ERP & training systems such as SAP and Master Controls We… more
- Intellia Therapeutics (Cambridge, MA)
- …disorders, viral infections, inflammatory disorders and many more. Summary: Reporting to the Senior Director of Quality, the (Sr) QA Manager, Ex Vivo will ... field with 7+ years of Quality Assurance experience in a GMP regulated environment. Solid understanding and application of regional regulatory requirements… more
- Cresco Labs (Chicago, IL)
- …Manager, you will be responsible for supporting the Manufacturing Quality Director in overseeing manufacturing process controls and parameters across the enterprise, ... that meets all specifications and brand consistency. Under the direction of the MQA Director , you will also assist with efforts to track and trend manufacturing and… more
