Primary Responsibilities * Provide GMP quality oversight for internal operations and CMOs ... This position requires the ability to travel independently overnight and/or work after hours as ...
Primary Responsibilities * Provide GMP quality oversight for internal operations and CMOs ... This position requires the ability to travel independently overnight and/or work after hours as ...
Associate Director, Quality Operations
Princeton, NJ · On-site
$145K - $181K/yr
Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial ... This position requires the ability to travel independently overnight and/or work after hours as ...
Associate Director, Quality Operations
Princeton, NJ · On-site
$145K - $181K/yr
Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial ... This position requires the ability to travel independently overnight and/or work after hours as ...
Director, Manufacturing
Princeton, NJ · Hybrid
Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings ... This position requires the ability to travel independently overnight and/or work after hours as ...
Director, Manufacturing
Princeton, NJ · Hybrid
Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings ... This position requires the ability to travel independently overnight and/or work after hours as ...
Director, Manufacturing
Princeton, NJ · On-site
$173K - $216K/yr
Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings ... This position requires the ability to travel independently overnight and/or work after hours as ...
Director, Manufacturing
Princeton, NJ · On-site
$173K - $216K/yr
Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings ... This position requires the ability to travel independently overnight and/or work after hours as ...
... CMOs on a weekly or monthly basis as required by the CMOs Sends monthly reporting to various ... Must be able to drive a vehicle and daytime/overnight travel as required. BENEFITS 401K (4% Match ...
... CMOs on a weekly or monthly basis as required by the CMOs Sends monthly reporting to various ... Must be able to drive a vehicle and daytime/overnight travel as required. BENEFITS 401K (4% Match ...
Field Service Engineer II - Laboratory Instrument Services - SW USA
Albuquerque, NM · On-site
$130K/yr
... CMOs). Our comprehensive range of services includes laboratory consulting, real estate services ... Ability to travel up to 80% overnight. * Ability to lift up to 50lbs. * A valid U.S. drivers ...
Field Service Engineer II - Laboratory Instrument Services - SW USA
Albuquerque, NM · On-site
$130K/yr
... CMOs). Our comprehensive range of services includes laboratory consulting, real estate services ... Ability to travel up to 80% overnight. * Ability to lift up to 50lbs. * A valid U.S. drivers ...
Manager, Outsourced Manufacturing
Foster City, CA · On-site
$136K - $176K/yr
Executes the regular, tactical management of CMOs to ensure Gilead's products are manufactured in ... Ability to travel internationally, including overnight up to 10% of the time is required
Manager, Outsourced Manufacturing
Foster City, CA · On-site
$136K - $176K/yr
Executes the regular, tactical management of CMOs to ensure Gilead's products are manufactured in ... Ability to travel internationally, including overnight up to 10% of the time is required
Vice President, Quality
Cambridge, MA · Hybrid
Ability to work successfully with contract manufacturing (CMOs) and research organizations (CROs ... Ability to travel approximately 20% to various meetings including overnight trips. Some ...
Vice President, Quality
Cambridge, MA · Hybrid
Ability to work successfully with contract manufacturing (CMOs) and research organizations (CROs ... Ability to travel approximately 20% to various meetings including overnight trips. Some ...
Manufacturing Engineer
Madison, WI · On-site
$91K - $155K/yr
... CMOs) to drive continuous improvement efforts and ensure product quality that meets internal ... Ability and means to travel 10% between Exact Sciences locations may include overnight/weekend ...
Manufacturing Engineer
Madison, WI · On-site
$91K - $155K/yr
... CMOs) to drive continuous improvement efforts and ensure product quality that meets internal ... Ability and means to travel 10% between Exact Sciences locations may include overnight/weekend ...
Manager, Outsourced Manufacturing
$136K - $176K/yr
Executes the regular, tactical management of CMOs to ensure Gilead's products are manufactured in ... Ability to travel internationally, including overnight up to 10% of the time is required
Manager, Outsourced Manufacturing
$136K - $176K/yr
Executes the regular, tactical management of CMOs to ensure Gilead's products are manufactured in ... Ability to travel internationally, including overnight up to 10% of the time is required
Field Service Engineer
Los Angeles, CA · On-site
$130K/yr
... CMOs). Our comprehensive range of services includes laboratory consulting, real estate services ... Travel to various customer locations as required; overnight travel may be necessary. What you'll ...
Field Service Engineer
Los Angeles, CA · On-site
$130K/yr
... CMOs). Our comprehensive range of services includes laboratory consulting, real estate services ... Travel to various customer locations as required; overnight travel may be necessary. What you'll ...
... CMOs). Our comprehensive range of services includes laboratory consulting, real estate services ... Travel to various customer locations as required; overnight travel may be necessary. What you'll ...
... CMOs). Our comprehensive range of services includes laboratory consulting, real estate services ... Travel to various customer locations as required; overnight travel may be necessary. What you'll ...
Sr. Project Engineer, Contract Manufacturing Sciences
Madison, WI · On-site
$91K - $155K/yr
... CMOs) to drive continuous improvement efforts and ensure product quality that meets internal ... Ability and means to travel 10% between Exact Sciences locations may include overnight/weekend ...
Sr. Project Engineer, Contract Manufacturing Sciences
Madison, WI · On-site
$91K - $155K/yr
... CMOs) to drive continuous improvement efforts and ensure product quality that meets internal ... Ability and means to travel 10% between Exact Sciences locations may include overnight/weekend ...
Manufacturing Engineer
Madison, WI · On-site
$91K - $155K/yr
... CMOs) to drive continuous improvement efforts and ensure product quality that meets internal ... Ability and means to travel 10% between Exact Sciences locations may include overnight/weekend ...
Manufacturing Engineer
Madison, WI · On-site
$91K - $155K/yr
... CMOs) to drive continuous improvement efforts and ensure product quality that meets internal ... Ability and means to travel 10% between Exact Sciences locations may include overnight/weekend ...
Overnight Cmos information

Other
Posted 11 days ago
Job description
Please note that this position is based in San Diego, CA or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.
- Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products
- Manage batch review, disposition, and release activities for drug substance and drug product manufacturing and packaging
- Lead QA oversight of technology transfer, process validation, registration batches, deviations, and process changes at CMOs
- Serve as the primary quality interface with CMOs to ensure compliance with SOPs, Quality Agreements, and regulatory expectations
- Lead investigations, change control, CAPA activities, and risk assessments related to GMP operations
- Support complaint handling activities, including investigation and closure
- Support the design, implementation, and maintenance of Acadia's GMP quality management system in compliance with US and international regulations
- Provide on-site GMP quality support at CMOs, including participation in audits and inspections as required
- Represent Quality Assurance on crossfunctional GMP manufacturing, packaging, supply chain, and development teams
- Other duties as assigned
- Bachelor's degree in Chemistry, Biology, or a related life science
- Minimum of 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry
- Minimum of 5 years of experience in a Quality Assurance role supporting GMP operations
- Demonstrated experience with US FDA and international GMP regulations
- Experience overseeing CMOs and outsourced GMP manufacturing activities
- Ability to travel up to 15-20%
This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
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