CMC Senior Manager, Biologics Manufacturing & Development
Mirador Therapeutics, Inc.
Mirador Therapeutics, Inc. is a clinical-stage precision medicine company based in San Diego, focused on immunology and inflammation. This position provides technical oversight of biologics development and manufacturing to supply clinical materials across multiple programs, ensuring cGMP compliance and successful technology transfer to CMOs. Responsibilities include authoring regulatory sections, guiding process development at CMOs, and implementing a data framework to standardize development #J-18808-Ljbffr Mirador Therapeutics, Inc.
- Mirador Therapeutics, Inc. seeks a senior scientific leader to oversee biologics development and manufacturing for clinical supplies. You will supervise CMC activities across CMOs, ensure quality documentation, and drive data‑driven decisions across programs. Strong regulatory...Senior
$125k - $175k
...’s Mirador360™ precision development engine leverages the latest... ...technical oversight of biologics development and manufacturing to deliver clinical trial... ...Responsibilities Supports the CMC team in authoring Quality... ...assessments for change management and/or deviation...SeniorContract work- SRT Therapeutics Inc. is seeking an Associate Director, Biologics CMC, to support biologics development from upstream cell culture to regulatory submissions. The role offers a unique opportunity to influence large molecule programs. With responsibilities including technical...Senior
- ...biopharmaceutical company in San Diego is seeking a Director/Senior Director of AOC Process Development and Manufacturing to oversee oligonucleotide synthesis and... ...leading tech transfer for various programs, managing CMC activities, and ensuring compliance with FDA and...Senior
$132k - $172k
...patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is... ...regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This... ...management activities for biologic products, with a strong focus...SeniorFull timeTemporary workRemote workWorldwide- Pfizer seeks a Scientist/Sr. Specialist to support downstream process development for biologics and therapeutic products. The role emphasizes hands-on downstream PD experience, chromatography, NFF, and TFF to optimize purification processes. The ideal candidate will have...Senior
- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs in San Diego to provide... ...leadership for CMC activities across development and commercial programs. The role... ...functional collaboration with development, manufacturing, QA, and regulatory teams. The ideal...SeniorRemote job
- Travere Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing to lead technical oversight of biologics manufacturing from late‑stage development through commercialization at external CDMOs. Focus will be on downstream...SeniorRemote job
$266k - $295k
...redosing. Job Summary The Director/Senior Director of AOC Process Development and Manufacturing - Oligonucleotide will lead all... ...strong understanding of cGMP and CMC strategy. Prior experience... ...strategies in collaboration with CMOs Manage tech transfer activities between...SeniorSummer holiday- ...Cmc Formulation ProfessionalKumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments... ...together an accomplished management team and distinguished scientific... ...process development and manufacturing. The ideal candidate will...Senior
- ...Therapeutics is seeking a Senior or Executive Director to lead the analytical development and QC function within CMC. This leadership role... ...validation, transfer, lifecycle management, and troubleshooting... ...support program timelines and manufacturing readiness through close...SeniorFlexible hours
- ## High Throughput Biology Senior Research AssociateApplylocations: San Diego, CAtime type: Full timeposted on: Posted Todayjob requisition... ...Associate to join our Human Cell Core, contributing to the development and execution of advanced human cell models at scale. The...SeniorSummer workFlexible hoursRotating shift
$93.6k - $156k
Pfizer Worldwide Research & Development, La Jolla, CA Pfizer Worldwide Research and Development in La Jolla, CA is seeking a highly motivated scientist to join the Structural Biology and Protein Sciences (SBPS) Group within the Department of Oncology Medicinal Chemistry...SeniorPermanent employmentFull timeH1bLocal areaWorldwideVisa sponsorshipWork visaRelocation package- ...candidates from early discovery to clinical development through strategic prioritization,... ...mechanistic understanding of underlying biology. Generate and lead new target nomination... ...discovery programs Experience successfully managing a team directing and coaching employees....Summer holidayLocal areaShift work
$76.4k - $114.6k
...seeking a dedicated and skilled Senior Research Associate to join... ...within our Molecular & Cell Biology group. The successful candidate... ...slices. Experience in method development and process optimization for... ...request to the recruiter or hiring manager, or contact Talent...SeniorSummer workFlexible hoursWeekend workEarly shift$155k - $190k
...are seeking an experienced CMC Project Management professional to lead the... ..., ensuring validation and manufacturing readiness milestones are met... ...Manufacturing, Analytical Development, and Quality (and external... ...the CMC project lead and senior stakeholders Maintain timely...SeniorFlexible hours$143.29k - $266.11k
...of our Cell Therapy Process Development team within Pharma Technical... ...Analytical Development, Research, Manufacturing Operations, and cross-... ...extensive experience: PhD in biological sciences, chemical... ...Demonstrated success building, managing, and developing highly productive...SeniorFull timeLocal areaRelocation package- Janux Therapeutics seeks a Senior Director, Clinical Supply Chain to lead and... ...partners with Clinical Operations, CMC, Quality, and Regulatory to align planning, manufacturing, and trial execution. The ideal candidate has deep biologics experience, oncology background preferred...Senior
- ...responsible for identifying and validating development opportunities across multiple disease... ...functional and will work closely with Research Biology, Clinical Development/Clinical... ...patient-selection strategies. Experience managing CROs, academic collaborations, and external...SeniorSummer holidayLocal area
$228k - $315k
Protego focuses on the discovery and development of first-in-class small molecule... ...is seeking an experienced Senior Director, Regulatory Affairs (CMC) to join our small regulatory team... ..., personally driving submissions, managing CDMO and consultant partners, and...SeniorFull timeWork at officeMonday to Friday- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role involves preparing CMC documents, ensuring regulatory compliance, and coordinating global submissions. The ideal candidate...SeniorRemote job
$257k - $275k
...Therapeutics is seeking a Senior Director, Clinical... ...into late-stage development. This is a hands-... ...Operations, CMC, Quality, and Regulatory... ...supply planning, manufacturing, and trial... ...deep experience in biologics and global clinical... ...as neededSelect, manage, and oversee external...SeniorFull timeSummer workRelocationRelocation package- ...lead on-the-floor QA oversight across biologics production, including cell culture, fermentation... ...-finish. You will supervise QA staff, manage deviations, CAPAs, and change controls... ...GxP compliance. You'll partner with Manufacturing, MSAT, Supply Chain, and QA to drive...Senior
- ...ResponsibilitiesContribute to the design, development, and optimization of LNP... ...release characteristics, and biological performance.Develop scalable, GMP-compatible manufacturing processes to support program... ...regulatory expectations for CMC development and experience...
- ...nucleic acids, and biologics. Our proprietary... ...pharmaceutical development, SpiderX is building... ...Description The Senior Scientist,... ...and the long‑term manufacturability strategy. The ideal... ...demonstrated ability to manage multiple... ...with regulatory CMC expectations for...Senior
$150k - $195k
...analytical operations of a biologics product and serves as an analytical... ...for analytical method development, validation, and transfer in... ...indication.Responsibilities:Manage and oversee method development... ...to ensure that products are manufactured and released in compliance...Full timeTemporary workRemote work$132k - $172k
...patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is... ...regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This... ...for combination products or biologic products when applicable; prior...SeniorFull timeTemporary workRemote work$170k - $185k
...the cell potency analytical development team to develop and optimize... ...to health authority queries· Manage assay transfer to the Artiva... ...Microbiology, Cell or Molecular Biology or Biochemistry) with 10+ years... ...authoring analytical/CMC sections of regulatory submissions...Flexible hours- Director / Senior Director, Chemistry - Peptide... ...discovery and development of... ...radiotherapeutics targeting key biological pathways for... ...will direct and manage the Discovery and... ...partnership with CMC, Clinical, and Regulatory... ...Pharmaceutical Manufacturing Referrals...SeniorFull timeTemporary work
- Northrop Grumman Aeronautics Systems in San Diego, CA is seeking a Senior Principal Program Manager to lead end-to-end Product Support proposal content development as a Proposal Lead within the PS IPT. The role involves capture planning, Basis of Estimate development,...Senior
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