Senior QA Lead, Drug Substance GMP & CDMO Oversight
$186k - $225kStructure Therapeutics Inc.
Structure Therapeutics Inc. in South San Francisco is looking for an Associate Director of Quality Assurance. This role is pivotal for overseeing late-phase drug substance manufacturing and ensuring compliance with GMP regulations. The ideal candidate will have over 10 years of experience in the pharmaceutical or biotechnology sectors, with proven leadership abilities and the capacity to collaborate cross-functionally. The position includes a robust compensation package, and the estimated salary range is $186,000 - $225,000, depending on qualifications and experience. #J-18808-Ljbffr Structure Therapeutics Inc.
$186k - $225k
...and computational drug discovery technology... ...operational quality oversight of late‑phase drug substance (DS) manufacturing... ...serve as the primary QA point of contact... ...vendors, ensuring GMP compliance, regulatory... ...Serve as the QA lead for drug substance CDMO oversight, ensuring...SuggestedContract workWork at office$174k - $227k
...and no longer the leading cause of death in... .... Position Title Senior Manager, CMC Quality... ...small molecule drug substance, drug product, placebo... ...and specification oversight, with additional... ...tracking and trending of CDMO generated... ...Ensure alignment with GMP, GDP, and...Senior- ...created with the belief that drug discovery and... ...oriented GxP and Regulatory QA Lead to join our fast-... ...assignments, GxP (GLP/GCP/GMP) compliance and FDA 21... ...Operations, Engineering, CRO, CDMO, CMC, etc.) to ensure... ...or related fields. Seniority Level Mid-Senior level...SuggestedFull timeWork at office
- A leading biotech company is seeking a self-motivated GxP and Regulatory QA Lead to oversee compliance within clinical and non-clinical operations. The role requires at... ...detail. This full-time position supports innovative drug development processes and offers the...SeniorFull time
$161.11k - $185.62k
...frontier in innovative drug design aimed at improving... ...seeks an experienced Senior Scientist to join the Analytical... ...method development, oversight of method validation at... ...conducted at external CDMO/CRO partners. The... .... Key Responsibilities Lead analytical method development...SeniorContract work$175k - $190k
Position Summary The Senior Drug Product Process... ...is responsible for leading all CGMP drug product... ...commercial launch at CDMO’s with a primary... ...with CDMOs, CMC, CSM, QA, RA, and subject... ...process knowledge and oversight for new product... ...experience supporting GMP manufacturing and...SeniorContract workLocal area- IDEAYA is seeking a Senior Manager, Drug Safety Operations to oversee ICSR management at our South San Francisco office. This role involves operational excellence, vendor oversight, and regulatory compliance as you manage Individual Case Safety Reports across the development...SeniorWork at office
- ...medicine company in South San Francisco is seeking a Senior Manager, Drug Safety Operations to lead ICSR management. This role requires operational excellence... ...pharmacovigilance experience and strong operational oversight skills. With a passion for oncology, you'll...Senior
- ...be responsible for managing GMP release and stability testing... ...will be responsible for leading, facilitating and supporting... ...bridging. Manage and provide oversight for CDMO placebo, DS, and DP stability... ...release/stability testing of drug substance and drug products. Manage...Contract work
$67 - $76 per hour
...modalities including antibody-drug conjugates (“ADCs”), T... ...for managing GMP release and stability... ...will be responsible for leading, facilitating and supporting... .... Manage and provide oversight for CDMO placebo, DS, and DP... ...testing of drug substance and drug products. Manage...Hourly payFull timeContract workTemporary workSummer work- Director/Senior Director Drug Product Development and Manufacturing Department... ...Define and lead drug product development strategy... ...functions to define optimal drug substance properties and control strategies... ...including FDA, EMA, ICH, GCP, and GMP Provide person-in-plant...SeniorFull timeImmediate start
$167.4k - $310.8k
...and computational sciences are transforming drug discovery and development. Roche's... ...learning (ML) techniques. We are seeking a Senior or Principal Machine Learning Scientist to... ...you will: Technical Leadership & Strategy: Lead the design and evolution of scientific reasoning...SeniorLocal areaWorldwideRelocation package$275k - $310k
...functional project plans, leading the integrated CMC... ...driven recommendations to senior leadership. Define... .... 3. Strategic CMO/CDMO Oversight & External... ...with functional leads (Drug Substance, Drug Product, and Analytical... ...systems in conjunction with QA leadership such as...Senior$247k
A leading biotechnology company is looking for a Project Team Leader to oversee cross-functional teams in the development of oncology therapies... ...in life sciences or medicine and over 10 years of experience in drug development. Responsibilities include guiding projects from...Senior$184k - $227k
...integrates expertise in small‑molecule drug discovery, structural biology... ...Summary We are seeking a Senior Manager, Drug Safety... ...be the day‑to‑day operational lead and subject‑matter expert for... ...Manager, Compliance and Vendor oversight. The position is based in our...SeniorTemporary workLocal area- A biotechnology company in San Francisco is seeking a Head of Drug Safety & Pharmacovigilance to ensure the safety and efficacy of... ...therapies for immune-mediated diseases. The role demands strategic oversight, scientific leadership, and collaboration across teams to...Senior
$200k - $230k
...of External Quality to lead the Quality Assurance function... ...Operations (CMO) Oversight and Supplier Quality... ...strategic vision for the QA role in the company and... ...starting material (SM), drug substance (DS) and drug product (... ...and disposition of GMP starting materials, Drug...Contract workInternshipLocal area3 days per week- A leading biotechnology firm in South San Francisco is seeking a Director/Senior Director of Drug Product Development and Manufacturing. The successful candidate will lead the development... ...Ph.D. and have substantial experience in GMP manufacturing and drug product development...Senior
$200k - $250k
A leading pharmaceutical company based in South San Francisco is seeking an experienced drug product development leader. The role demands a Ph.D. and over 10 years of experience in drug product development, particularly in late-phase projects involving NDA/MAA filings....Senior- Initial Therapeutics, Inc. is seeking a Senior Director of Pharmaceutical Development in South San Francisco to lead small molecule drug product development. You will oversee formulation processes at CDMOs, ensuring drug products meet regulatory standards and operational...Senior
$167.4k - $310.8k
A leading research organization is seeking a Senior Machine Learning Scientist in South San Francisco to drive advancements in AI for drug discovery. The ideal candidate will have a PhD or MS with extensive research experience in machine learning, be proficient in Python...SeniorRelocation package- ...Giga QA Lead Opportunity Giga has recently raised a $61M Series A and has several paying customers, including DoorDash. We're building... ...let us scale testing as the product and team grow As a senior QA lead, you'll be the core owner of ensuring quality releases...Senior
- ...research firm in South San Francisco is seeking a Senior Data Engineer to join their Engineering team. In this role, you will lead projects, collaborating with various research groups to create data systems that enhance drug discovery. The ideal candidate should have a BS...Senior
$186.21k - $217.25k
...Senior Manager, Quality Compliance Cytokinetics is a specialty... .... This position will lead and coordinate Quality... ...as a key contributor on the QA Compliance team, leading and... ...systems that enable clear oversight of internal and external GMP activities Provide technical...SeniorContract workWork at office$300k - $375k
...culture! Position: The Senior Director, Drug Safety and Pharmacovigilance will work... ...Monitors and Clinical Development Lead Physician(s) to facilitate signal... ...for strategic leadership and medical oversight of assigned Annexon product(s) and will...SeniorRemote workFlexible hours$168.1k - $312.3k
...Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche's Research and Early... ...frameworks. We operate with a flat scientific structure in which senior scientists define their own research agendas, and leaders act as...SeniorLocal areaWorldwideRelocation package$139k - $169k
...goal is to fundamentally change the outcomes for these patients. We are seeking an experienced and highly motivated Senior Scientist for the Drug Product Development group who can work in a collaborative and dynamic environment. The scientist in this role is responsible...Senior3 days per week- ...seeking an experienced and highly motivated Senior Scientist I to join our Quality Control... ...achieve QC deliverables for release of GMP drug substance and drug product batches and manage... ...teams. Collaborate with analytical leads to achieve release and stability program...SeniorTemporary workFlexible hours
$90k - $210k
...We are seeking a Senior Manager, Enterprise AI to lead the execution of Cellares' enterprise... ...real-world impact across GMP systems (MES, ERP, LIMS,... ...model monitoring, and human oversight Partner with... ...manufacturing the living drugs of the 21st century. The company...SeniorFlexible hours$232k - $271k
...analytical control strategies for drug substance (DS), drug product (DP), and... ...will manage external CRO/CDMO partners in a virtual development... ..., budgets, and timelines. Leads external CRO/CDMO activities... .... Supports selection and oversight of external vendors, including...Full timeTemporary workFor contractorsWork at officeMonday to FridayFlexible hours3 days per week
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