Senior QA Associate, GMP Drug Product
Amgen SA
Amgen in Thousand Oaks seeks a Sr. Associate Quality Assurance to support the Plant QA organization, providing daily oversight of Drug Product manufacturing and ensuring processes, procedures, and quality systems meet regulatory requirements. Duties include electronic batch review, GMP document revision, maintenance work order approvals, and evaluating deviations, with shifts to support 24/7 production in a clean room environment. #J-18808-Ljbffr Amgen SA
$104.29k - $141.09k
...while transforming your career.Drug Product Quality Assurance... ...organization the Drug Product QA Specialist provides Quality oversight... ...oversight to operational activities associated with the aseptic Drug Product... ...monitoring systems within GMP manufacturing environments...SuggestedFull timeFlexible hours- ...Amgen seeks a Drug Product Quality Assurance Specialist to provide quality oversight for aseptic drug product manufacturing operations at... ...contamination control, environmental monitoring, and utility systems in GMP manufacturing Excellent written and verbal communication...Suggested
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$111.94k - $151.45k
...transforming your career.Scientist/ Senior Engineer - Commercial Drug ProductWhat you will doLet’s do this.... ...this vital role you will serve as Drug Product SKU Lead providing technical and... ...filings, pre-approval inspections, and GMP documentation.Experience with non-conformance...SeniorFull timeContract workFlexible hours- Amgen’s Thousand Oaks site seeks a Drug Product Quality Assurance Specialist to provide quality oversight for aseptic manufacturing and inspection areas. You will ensure compliance with cGMP, quality systems, and regulatory expectations while partnering with Manufacturing...Flexible hours
- Amgen Inc. in Thousand Oaks seeks a Process Development Senior Scientist to advance drug product technologies for biologics, with emphasis on ADC formulation, stability, and scalable processes. You will collaborate across functions and apply data science to improve development...Senior
- ...Responsibilities Serve as process engineering lead and SKU owner for drug product formulation, fill/finish, and lifecycle management Design and execute laboratory and on-site studies for process development, characterization, and scale-up activities Lead technology...Senior
- Amgen is seeking a Process Development Principal Scientist to lead Biologics drug product formulation and process development in the Pre-Pivotal Drug Product Technologies group. You will design, develop, and optimize formulations for diverse modalities including ADCs and...
$126.07k - $170.56k
...part of the Amgen team. Join us and transform the lives of patients while transforming your career.Process Development Senior Scientist - Drug Product TechnologiesWhat you will doLet’s do this. Let’s change the world. In this vital role you will join Pre-Pivotal Drug Product...SeniorFull timeFlexible hours- Amgen seeks a Process Development Principal Scientist to lead early-stage biologics drug product formulation and process development, including ADCs and oligonucleotides. You will integrate formulation, analytical data, and stability insights to guide scalable, quality...
$141.84k - $191.9k
...Development Principal ScientistWhat you will doLet’s do this. Let’s change the world. In this vital role you will join the Pre-Pivotal Drug Product Technologies group, which is responsible for early-stage drug product development across diverse modalities, including antibody-...Full timeFlexible hours- Aditi Consulting is seeking a GMP-literate analytical chemist in Thousand Oaks, CA, to perform routine and non-routine GMP analytical testing of drug substances, products, and materials. You’ll independently execute established methods, document results, and ensure data...Senior
- Amgen in Thousand Oaks, CA, seeks an Associate Quality Assurance to ensure sampling and inspection of raw materials and components. The role... ...training records, and performing quality reviews within a GMP environment. Training can be provided for GMP exposure; ADA accommodations...
- Amgen in Thousand Oaks, CA seeks an Associate Quality Assurance to sample and inspect raw materials... ...in clean room sampling areas. Training on GMP will be provided; prior GMP is a plus.... ...include high school diploma with 2 years QA experience or an Associate's + 6 months, or...
- ...transforming your career. What You Will Do Let’s do this. Let’s change the world. In this vital role you will join the Pre-Pivotal Drug Product Technologies group, which is responsible for early-stage drug product development across diverse modalities, including antibody-...Flexible hours
- Duration: 06 months contract Shift: Standard Working Hours Job Summary: Perform GMP analytical testing in support of synthetic drug substance, drug product, raw material, stability, release, and/or investigational activities. Independently execute established analytical...SeniorContract workShift work
- ...Amgen seeks a Principal Product Quality Leader to provide technical expertise and product leadership... ...Teams Author, review, and maintain GMP and regulatory documentation; execute... ...Experience with synthetic pharmaceutical bulk and drug product development and analytical...
$138.64k - $187.57k
...transforming your career.Principal Product Quality Leader (Synthetics)... ..., and investigations associated with product manufacturing, in... ...ownership, authoring and review of GMP and regulatory documents, execution... ...pharmaceutical bulk and drug product development, manufacturing...Full timeRemote workFlexible hours$157.74k - $213.41k
...transforming your career.Process Development Senior Principal Scientist BioconjugatesWhat... ..., development, and implementation of drug substance manufacturing processes and technologies... ...and technology transfer to GMP production facilities Develop strategies to ensure...SeniorFull timeFlexible hours- Amgen is seeking a Principal Product Quality Leader (Synthetics) to provide technical expertise and lead quality initiatives across functions... ...on‑site leadership with some remote options, ownership of GMP processes, and ensuring product quality throughout development and...Remote work
$202.94k - $274.57k
...lives of patients while transforming your career.Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)What you will doLet’... ...with drafting regulatory filings (IND, MAA), annual product reviews (APR), briefing documents, and responses...SeniorFull timeContract workFlexible hours- Amgen in Thousand Oaks, CA seeks a Process Development Senior Associate to join the Drug Substance Technologies - Synthetics group, collaborating with chemists, engineers, and scientists to advance drug substance development from early to late-stage. The role emphasizes...Senior
- Sage Publishing is seeking a Product Owner to own the Dynamics CRM backlog and partner with Sales and business teams. You will translate needs into clearly defined work for delivery teams, lead discovery, and manage dependencies across Sage Technology. You will collaborate...SeniorRemote work
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Job DescriptionDirector of Product ManagementAt Guitar Center, Product Development builds... ...Champion deep empathy for customers and associates and ensure Product is a trusted, outcome... ...risks, and results to stakeholders and senior leadership.Strengthen roadmap quality by...SeniorWork at office- Amgen is seeking an Associate Director to lead the Clinical Data Hub (CDH) product within the CDA-DTI structure in Thousand Oaks. You will set the product vision, strategy, and roadmaps enabling discovery, integration, governance, and reuse of clinical data across studies...Senior
$198.33k - $268.33k
...transform the lives of patients while transforming your career. Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence What you... ...that evaluates actual execution, system effectiveness, product impact, data integrity, and broader applicability....SeniorContract workFlexible hours- Amgen in Thousand Oaks seeks an Associate Director of Information Systems for the Clinical Data Hub to lead a cross-functional product team and define a multi-year roadmap aligned with... ...teams, and communicate strategy to senior leadership while delivering measurable business...Senior
- Takeda is seeking a Quality Assurance Validation Associate in Thousand Oaks to oversee validation deliverables and change controls, ensuring GMP and GxP compliance across facilities, utilities, equipment, and computerized systems. The role emphasizes risk assessment, traceability...
$157.74k - $213.41k
...characterize critical quality attributes and advance product and process understanding. You will... ...characterization.Collaborate closely with drug substance and drug product process... ...impurities, etc.Solid understanding of GLP and GMP requirements and their application in a...SeniorFull timeContract workFlexible hours
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