Current jobs related to Associate Director, Manufacturing Science - California - Insmed Incorporated

  • Associate Director of Pharmacovigilance Science

    4 weeks ago

    California, United States BioPhase Full time

    Job Title: Associate Director of Pharmacovigilance ScienceBioPhase Solutions is seeking a highly skilled Associate Director of Pharmacovigilance Science to join our team in Southern California. As a key member of our Life Sciences community, you will be responsible for managing pharmacovigilance activities for assigned products or therapeutic areas.Key...

  • Manufacturing Director

    4 weeks ago

    California, United States Proclinical Staffing Full time

    {"title": "Director of Manufacturing", "subtitle": "Join Proclinical Staffing in the San Francisco Bay Area, CA", "content": "We are seeking a highly experienced Director of Manufacturing to lead our pharmaceutical manufacturing operations in the San Francisco Bay Area, CA.The successful candidate will have significant experience in managing Contract...

  • Business Development Manager

    3 weeks ago

    California, United States Life Science People Full time

    Job Title: Business Development ManagerWe are seeking a highly motivated and experienced Business Development Manager to join our team at Life Science People. As a key member of our sales team, you will be responsible for driving revenue growth and expanding our client base within the pharmaceutical and biotech contract manufacturing sectors.Key...

  • Biomedical Sciences Professor

    4 weeks ago

    California, Missouri, United States Western University of Health Sciences Full time

    Job Title: Assistant/Associate/Professor of Biomedical SciencesWestern University of Health Sciences is seeking a highly qualified individual to join our faculty as an Assistant/Associate/Professor of Biomedical Sciences. As a member of our team, you will have the opportunity to contribute to the development of our students and advance the field of...

  • Project Director

    2 months ago

    California, United States Mace Full time

    About MaceMace is a leading global consultancy and construction company that delivers projects across the globe. Our purpose is to redefine the boundaries of ambition, creating places that are responsible and bringing transformative impact to our people, communities, and societies.Job SummaryWe are seeking a highly experienced and skilled Project Director to...

  • Senior CMC Director

    2 months ago

    California, United States Meet Full time

    Title: Senior Director, CMCOverview: A forward-thinking clinical-stage biopharmaceutical organization is in search of a highly skilled and driven Senior Director, CMC. The ideal candidate will be instrumental in guiding and managing CMC initiatives pertaining to the development, manufacturing, and supply chain of drug substances and products. This position...

  • Director of CMC Operations

    2 months ago

    California, United States Meet Full time

    Title: Senior Director, CMCOverview: A forward-thinking clinical-stage biopharmaceutical organization is in search of a highly skilled and driven Senior Director, CMC. The ideal candidate will be instrumental in directing and managing CMC functions associated with the development, manufacturing, and supply chain of drug substances and products. This position...

  • Associate Director Statistical Programming

    1 month ago

    California, United States Barrington James Full time

    Associate Director Statistical ProgrammingWe are seeking a highly skilled Associate Director, Statistical Programming to join our team at Barrington James. This is an exciting opportunity to work with a rare disease focused Biotech in San Francisco.The ideal candidate will have a strong background in Statistical Programming, with a minimum of 5 years of...

  • Strategic Business Development Leader

    2 months ago

    California, United States Life Science People Full time

    About the CompanyLife Science People is a leading organization in contract development and manufacturing, recognized for its exceptional clinical trial supply solutions. The company is dedicated to delivering innovative and flexible approaches to product lifecycle management, spanning from clinical trials to market introduction. With advanced pharmaceutical...

  • Associate Director Biosample Operations

    1 week ago

    California, Missouri, United States Vir Biotechnology, Inc. Full time

    Job SummaryVir Biotechnology, Inc. is seeking an experienced Associate Director, Biosample Operations to join our team. The successful candidate will be responsible for planning and executing clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas.Key ResponsibilitiesDrive the...

  • Associate Director of Development, School of Law

    3 weeks ago

    California, United States University of San Francisco Full time

    About the RoleWe are seeking a highly skilled and experienced Associate Director of Development to join our team at the University of San Francisco School of Law. As a key member of our development team, you will be responsible for developing and managing relationships with our law school's donors, with a focus on expanding the major gift pipeline.Key...

  • Executive Director Business Development Lead

    1 month ago

    California, United States Celito Tech, Inc. Full time

    Job Title: Executive Director Business DevelopmentCelito Tech, Inc. is a leading partner in the biotech industry, specializing in helping companies scale from early clinical phases to pivotal trials and commercialization. Our team is dedicated to advancing the biotech industry with innovative solutions, a commitment to excellence, and fostering long-term...

  • Regulatory Affairs Director

    1 month ago

    California, USA, United States Planet Pharma Full time

    Job Title: Regulatory Affairs Associate Director/DirectorPlanet Pharma is seeking a highly skilled Regulatory Affairs Associate Director/Director to join our team in South San Francisco, CA. This is a 6-month contract opportunity.Key Responsibilities:Develop and implement competitive and effective global regulatory strategies for oncology products, including...

  • Director of Engineering

    1 month ago

    California, United States Shaw Bakers Full time

    Job Title: Director of EngineeringWe are seeking a highly experienced and skilled Director of Engineering to join our team at Shaw Bakers. As a key member of our Operations Team, you will be responsible for providing strategic leadership and direction to our engineering and maintenance teams.Key Responsibilities:Lead the engineering and maintenance teams to...

  • Clinical Program Director

    2 months ago

    California, United States EPM Scientific Full time

    Job SummaryEPM Scientific is seeking a highly motivated and experienced Clinical Program Lead to join our team. As a Clinical Program Lead, you will be responsible for managing a Phase III global study and leading the design, monitoring, data interpretation, and reporting activities related to the conduct of clinical studies.Key ResponsibilitiesStudy...

  • Material Handler

    4 weeks ago

    California, USA, United States Kelly Science, Engineering, Technology & Telecom Full time

    Clinical Material Handler Job DescriptionKelly Science & Clinical is seeking a highly organized and detail-oriented Material Handler to join our team in San Diego. As a Material Handler, you will play a critical role in ensuring the accurate receipt, storage, and distribution of clinical materials.Key Responsibilities:Receive, inspect, and process incoming...

  • Senior Director Business Development

    1 month ago

    California, USA, United States Leaman Life Sciences Full time

    Job Title: Senior Director Business DevelopmentWe are seeking a highly experienced Senior Director Business Development to join our team at Leaman Life Sciences. This is a brand new hire, to grow out the team in the US within Business Development.The Senior Director for Business Development will support global lead generation, manage customer information...

  • Director of Oncology Forecasting

    3 weeks ago

    California, United States EPM Scientific Full time

    EPM Scientific is seeking a seasoned professional to lead their Portfolio team as a Director of Oncology Forecasting. This role will be responsible for mentoring and developing a team of forecasters and commercial analytics professionals.Key Responsibilities:Develop and implement a US Forecasting strategy, acting as the primary liaison with therapeutic area...

  • Senior Director, CMC

    1 month ago

    California, USA, United States Meet Full time

    Senior Director, CMC Job DescriptionMeet is seeking a highly experienced Senior Director, CMC to lead and oversee CMC activities related to drug substance and drug product development, manufacturing, and supply chain. This role requires deep expertise in small molecules pharmaceutical development and commercialization, as well as a strong understanding of...

  • Semiconductor Manufacturing Process Lead

    2 months ago

    California, USA, United States Raytheon Full time

    About the RoleWe are seeking a highly skilled and experienced Process Engineering Manager to join our team at Raytheon. As a key member of our Focal Plane Operations Process Engineering department, you will be responsible for leading a team of process engineers in the development and implementation of semiconductor manufacturing processes.Key...

Associate Director, Manufacturing Science

3 months ago

California, United States Insmed Incorporated Full time



Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.



Recognitions

Named Science's Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for three years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in BiopharmaTM, Best Workplaces in New YorkTM, PEOPLE Companies That Care, Best Workplaces for WomenTM, Best Workplaces for MillennialsTM, and Best Medium WorkplacesTM lists.



Overview

Join the Technical Operations team as Associate Director of MSAT where you will support pipeline programs that change lives. At Insmed Gene Therapy you will be part of a collaborative team that works in a face paced and dynamic environment to bring viral vector gene therapies to market. Supporting our external manufacturing partners, you will be the process and data expert and work to further improve the process of manufacturing AAV based therapies. Working closely with Process Development and CMC teams you will be the bridge between the laboratory and GMP manufacturing.



Responsibilities

Works with management to plan and execute the MSAT department strategy for technology transfer from process development through to commercial manufacturing. Facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities. Supports manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements and scientific expertise in the Drug Substance and Drug Product. Provides strong technical leadership to process engineers, scientists, and associates for clinical and commercial production. May represent Insmed Gene Therapy as subject matter expert during external and internal regulatory submissions and compliance inspections. Travel will be required to support person-in-plant activities during production campaigns. Completes impact assessments for supplier change notifications and authors campaign summary reports. Will lead planning activities for process characterization and PPQ planning activities. Review batch records, SOPs, raw material specifications, development reports and GMP protocols. Support change control and the change management of different process versions and comparability assessments for process changes. Job Requirements: BS, MS, or PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field alongside significant leadership experience across Bioprocessing leadership and 8-10 years of work experienceBroad experience in all process areas (Upstream cell culture, downstream processing, and buffer) as well as drug product.Experience leading and/or interacting with GMP manufacturing, process validation, and tech transfer teams.Domestic and/or International travel required (20-40%)

Salary Range



Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

Flexible approach to where and how we work, regionally basedCompetitive compensation package including bonus Stock options and RSU awardsEmployee Stock Purchase Plan (ESPP)Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS:401(k) plan with company matchMedical, dental, and vision plansCompany-provided Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance Program (EAP)Mental Health on-line digital resourceWell-being reimbursementPaid leave benefits for new parentsPaid time off to volunteerOn-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.