Senior Director, Process Validation and Manufacturing Science and Technology

13 hours ago

Seattle, Washington, United States Vertex Pharmaceuticals Full time
Job Description

The Associate Director, Process Validation and Manufacturing Science Leadership will lead technical programs within the Vertex Biopharmaceutical Sciences and Manufacturing Operations (BSMO) network.

Key Responsibilities:
  • Manage and influence internal and external cross-functional teams to set strategic direction for late-stage development activities, leading to process performance qualification, associated CMC requirements, and regulatory submissions.
  • Manage and influence strategy for execution of process performance qualification (PPQ) and product life cycle, ensuring readiness and execution status for PPQ/CPV activities and deliverables.
  • Generate PPQ/PV and/or CPV documents (plans, protocols, reports) according to timelines and commitments/Quality Agreements.
  • Implement consistent process qualification, process validation, and CPV strategies.
  • Support the establishment of network strategies for drug substance/drug product manufacturing and testing.
  • Be an effective change agent and champion for continuous improvement and technical innovation within the BSMO network.
  • Collaborate with risk management and program management functions to articulate technical risks and develop/mitigate.
  • Liaise with tech leads from other programs to build collective biopharmaceutical operations knowledge.
  • Engage across industry forums to identify best practices and improvement opportunities.
Requirements:
  • 8+ years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience.
  • Master's or doctoral degree in a science or engineering field.
  • Experience in process validation at commercial scale and bench scale.
  • Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
  • Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management.
  • Advanced experience in a key technical leadership/management role in biologics process development, MSAT, and/or manufacturing.
  • Previous leadership experience working in a highly matrixed environment.
  • Experience with cGMP manufacturing, regulatory guidance, and health authority inspections.
  • Experience authoring/reviewing CMC product submissions and post-approval changes.
  • Experience working with external manufacturing partners (CDMOs), suppliers, and service providers.
  • Experience with operational excellence practices and root cause methodologies desirable.
  • Ability to travel, domestically and internationally, up to 25%.
Hybrid-Eligible:

This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

  • Associate Director, Process Validation, Manufacturing Science and Technology

    3 weeks ago

    Seattle, Washington, United States Vertex Pharmaceuticals Full time

    Job DescriptionThe Associate Director, Process Validation, Manufacturing Science and Technology (MSAT) role is a key leadership position within the Commercial Manufacturing and Supply Chain (CMSC) organization at Vertex Pharmaceuticals. This position will be responsible for leading technical programs within the Vertex Biopharmaceutical Sciences and...

  • Director of Process Development and Manufacturing

    3 weeks ago

    Seattle, Washington, United States SystImmune Full time

    Job Title: Director of Process Development and ManufacturingSystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). We are seeking a highly experienced Director of Process Development and Manufacturing to join our team in...

  • Director of Technology

    3 weeks ago

    Seattle, Washington, United States Global Information Technology Full time

    Job Title: Director of TechnologyGlobal Information Technology is seeking a highly experienced Director of Technology to lead our team of engineers and drive the development of our complex projects.Key Responsibilities:Lead and improve team development principles, reducing dependencies and accelerating production.Develop and implement technical strategies to...

  • Biotech Manufacturing Specialist

    7 hours ago

    Seattle, Washington, United States Validation & Engineering Group Full time

    Job SummaryThe Validation & Engineering Group is seeking a skilled Biotech Manufacturing Operator to join our team. As a key member of our production team, you will be responsible for executing and monitoring various steps in the production process of drug substances.This role involves working with bioreactors, filtration systems, chromatography equipment,...

  • Executive Director, Cell Therapy Process Development

    4 days ago

    Seattle, Washington, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking an experienced Executive Director to lead our Cell Therapy Process Development team.Role and ResponsibilitiesThe Executive Director, Cell Therapy Process Development will be...

  • Biotech Manufacturing Specialist

    3 weeks ago

    Seattle, Washington, United States Validation & Engineering Group Full time

    Job Title: Biotech Manufacturing OperatorJob Summary:The Biotech Manufacturing Operator is responsible for executing and monitoring various steps in the production process of drug substances. This role involves working with bioreactors, filtration systems, chromatography equipment, and other production technologies commonly used in the biotech industry.Key...

  • Associate Director Medical Science Liaison

    3 weeks ago

    Seattle, Washington, United States Eli Lilly and Company Full time

    Job Title: Associate Director Medical Science LiaisonEli Lilly and Company is seeking an Associate Director Medical Science Liaison to join our team in Seattle, WA. As a key member of our Medical Science Liaison team, you will play a critical role in building and maintaining relationships with external experts in the gastroenterology and immunology...

  • Vice President, Process Sciences and Development

    4 days ago

    Seattle, Washington, United States Lyell Immunopharma Full time

    Job SummaryWe are seeking a highly experienced and skilled Vice President, Process Sciences to join our team at Lyell Immunopharma. As a key member of our Technical Operations and CMC product development teams, you will be responsible for advancing cell therapy development, analytical development, and manufacturing.Key ResponsibilitiesAssure cell therapy...

  • Senior Materials and Process Engineer

    4 days ago

    Seattle, Washington, United States Blue Origin, LLC Full time

    Job SummaryWe are seeking a highly skilled Senior Materials and Process Engineer to join our team at Blue Origin, LLC. As a key member of our engineering team, you will be responsible for developing and implementing new manufacturing processes and materials for our aerospace systems.Key ResponsibilitiesDevelop and implement new manufacturing processes and...

  • Senior Manager/Director, Customer Quality Engineering

    3 days ago

    Seattle, Washington, United States Micron Technology Full time

    About the RoleMicron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence. We are seeking a senior leader to join our Global Quality team, which is a cornerstone of our reputation as a worldwide leader in the semiconductor industry.The ideal candidate will have experience...

  • Senior Process Development Engineer Composites Specialist

    16 hours ago

    Seattle, Washington, United States Blue Origin Full time

    Job SummaryWe are seeking a highly skilled Senior Process Development Engineer Composites to join our team at Blue Origin. As a key member of our composite manufacturing team, you will be responsible for developing and implementing new manufacturing processes for composite materials. Your expertise will be critical in ensuring the quality and reliability of...

  • Cell Therapy Process Development Director

    4 weeks ago

    Seattle, Washington, United States Dendreon Full time

    About the RoleWe are seeking a highly experienced and skilled Director of Process Sciences Cell Therapy to lead our Process Sciences group in the Research and Manufacturing Sciences Department. This role will be responsible for directing process tech transfer activities for our cell therapy internal and partner programs, as well as working closely with...

  • Senior Director, Biologics Formulation and Drug Product

    3 weeks ago

    Seattle, Washington, United States Vertex Pharmaceuticals Full time

    Job DescriptionVertex Pharmaceuticals is seeking a highly skilled Associate Director to lead the development of innovative formulations and drug delivery systems for biologic therapeutics. As a senior-level position, this role requires extensive expertise in protein chemistry, biophysics, and pharmaceutical sciences to optimize the stability, efficacy, and...

  • Senior Director Business Systems Transformation

    2 weeks ago

    Seattle, Washington, United States Blue Origin Full time

    About the RoleWe are seeking an experienced leader to join our Business Systems Transformation and Operations team as a Senior Director. This critical leadership role will report directly to the Senior Vice President of Enterprise Technology and will be responsible for leading the transformation and operation of our core business systems across Finance,...

  • Senior Validation Project Manager

    3 days ago

    Seattle, Washington, United States Omni Inclusive Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Validation Project Manager to join our team at Omni Inclusive. As a key member of our Analytical Sciences and Technology function, you will be responsible for the end-to-end management of method transfers and validations for our Cell Therapy Organization.This role requires a strong technical...

  • Project Manager

    3 days ago

    Seattle, Washington, United States NCMS: National Center for Manufacturing Sciences Full time

    Job SummaryWe are seeking a highly skilled Project Manager to join our team at the National Center for Manufacturing Sciences (NCMS). As a Project Manager, you will be responsible for planning and executing multiple projects simultaneously, while considering contingencies and alternatives.Key Responsibilities:Manage collaborative projects that meet...

  • Environmental Planner

    3 weeks ago

    Seattle, Washington, United States EA Engineering, Science, and Technology Full time

    Job Title: Environmental PlannerWe are seeking a highly skilled Environmental Planner to join our team at EA Engineering, Science, and Technology, Inc., PBC. As an Environmental Planner, you will play a key role in supporting our SEPA/NEPA planning consulting practice, working on a wide range of projects that promote environmental sustainability and...

  • Cell Therapy Process Development Director

    1 month ago

    Seattle, Washington, United States Dendreon Full time

    About DendreonDendreon is a leading biotechnology company dedicated to making a meaningful difference in the lives of patients with cancer. Our flagship product, PROVENGE, is a groundbreaking immunotherapy that harnesses the power of the patient's own immune cells to fight cancer.Job SummaryWe are seeking an experienced Director to lead our Process Sciences...

  • Science Educator

    1 month ago

    Seattle, Washington, United States Pacific Science Center Full time

    Outreach EducatorPacific Science Center is seeking a highly motivated and enthusiastic Outreach Educator to join our team. As an Outreach Educator, you will be responsible for delivering engaging and interactive science programs to schools and community events across Washington state.Key Responsibilities:Develop and implement hands-on science programs for...

  • Senior Director, Product Management

    5 days ago

    Seattle, Washington, United States Oracle Full time

    Job Title: Senior Director, Product ManagementOracle is seeking a highly experienced Senior Director to lead the Product Development organization for Oracle Cloud Infrastructure (OCI) Generative AI services and Data Science platform. As a key member of the OCI team, you will be responsible for defining the strategic direction and roadmap for our cloud-based...