Remote CMC Asset Lead Biologics (Bispecifics)
ShennonBio
ShennonBiotechnologies is seeking a director-level CMC leader to own end-to-end CMC for a trispecific TCE program, from discovery handoff through IND. The role is hands-on and reports to the Head of Research, with potential to become a full-time, SF-based position after initial consulting. The role requires regulating CMC strategy, budget ownership, and CDMO negotiations across US, Europe, and China, including regulatory meetings and Module 3 authoring. #J-18808-Ljbffr
- ...once, identifying functional leads in a single experiment. This unified... ...looking for someone to own CMC for it end to end, from the... ...MS with at least 12 years in biologics CMC. At least 1 biologic taken... ...there is 1 program today. Remote is fine and we have no geographic...Remote workAssetPermanent employmentFull timeInterim role
- ...Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This role will lead CMC activities... .... Local Boston candidates are preferred; remote East Coast candidates will also be considered....Remote workLocal area
- ...Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. This role partners with Regulatory Affairs, SME, Quality, Manufacturing...Remote work
- ...Travere Therapeutics, located in San Diego with remote flexibility, seeks a Director of Technical Operations (Biologics CMC Technical Writing). You will lead the preparation of CTD Module 2/3 for regulatory submissions, coordinating with Regulatory Affairs, QA, Manufacturing...Remote work
- Sage Bionetworks seeks an Associate Director, Computational Biology to lead a multidisciplinary team focused on applied scientific research... ...stewardship, and community engagement around Sage’s data assets. You will set scientific direction, data standards, and engagement...Remote jobAsset
- ...Location: North Carolina/Remote If you are... .... Director, Regulatory CMC reports to the Vice President... ...organization as pipeline assets advance through... ...regulatory authorities). Lead the authorship and coordination... ...in MSAT for MAB biological products. ~ Strong technical...Remote workAssetFull timeContract workVisa sponsorshipWork visa
- ...difference for people in need. Our lead asset, solrikitug, is a highly... ...Manufacturing, and Controls (CMC) project management... ...strong technical understanding of biologics manufacturing and CMC development... ...spend time in the office, and remote employees are expected to...Remote workAssetFull timeContract workWork at officeLocal area
$85 - $142 per hour
...technical talent with leading AI research labs.... ...&D Expert – ADC & Bispecifics Type:... ...hour Location: Remote Role Responsibilities... ...its own drug assets in-house and has taken... ...: discovery biology, medicinal chemistry... ...PD, toxicology, or CMC/formulation. ~5+...Remote workAssetHourly payContract workFor contractorsSummer work$199.22k - $284.6k
...works within a cross-functional Asset Maximization Team and is accountable for CMC activities supporting the end-to-... ...and lifecycle transition. The CMC Lead serves as the single, integrated... ...developing CMC strategies for complex biological products with significant process...AssetWork at officeWork from homeWorldwide2 days per week3 days per week$145 - $170 per hour
...next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading.... ...Regulatory CMC Lead Location: Boston, MA / Remote East Coast Shift : Monday-Friday,... ...Regulatory CMC leadership for a global biologics program. This role will lead CMC...Remote workHourly payFull timeTemporary workLocal areaMonday to FridayShift work- ...Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for... ...experience in CMC regulatory requirements for biologics and gene therapies. The ideal... ...promotes a collaborative work environment with flexible remote options. #J-18808-LjbffrRemote workFlexible hours
$189.5k - $235k
...Affairs-Global Regulatory Lead Vacancy No VN723... ...Radnor, PA, Oxford, UK, Remote, US Department Regulatory... ...have experience gained in biologics and the preparation of... ...trial labelling and CMC submissions for regulatory... ...are our greatest asset. We value the unique contributions...Remote workAssetFull timeWork at officeLocal areaWorldwideNight shift- ...CSL Behring seeks a Team Lead, Global Regulatory Affairs to drive CMC regulatory strategy for biological and non-biological products. This role collaborates with Global Operations, R&D, and QA to ensure timely, compliant submissions and lifecycle management. Ideal candidates...
- ...Primary Responsibilities 1. Global Regulatory CMC Strategy Lead and drive the global Regulatory CMC strategy for biologic ADC programs. Provide strategic guidance... ...Paris (France) Flexible for this to be Boston-office based, remote East-coast (USA) or hybrid....Remote workWork at officeFlexible hours
- ...Scorpion Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to guide regulatory... ...strategies across development. You will integrate disease biology, pharmacology, and clinical data to shape scientific strategy...
- ...Elanco is a global animal health leader seeking a senior Advisor, CMC Regulatory Affairs – Biologicals. The role focuses on regulatory guidance, submissions, and interactions to maintain product registrations and availability. Collaboration with Manufacturing, Quality...
- ...Regeneron Pharmaceuticals, Inc. seeks a Manager, CMC Regulatory Affairs - Biologics in Rensselaer, NY. This on-site role leads regulatory strategy and compliance for biologics, coordinating across development, submissions, and post-market activities with Global Regulatory...
$177k - $242k
...re looking for a Director, Gene Therapy CMC Lead on the Manufacturing, Science & Technology... ..., Biotechnology, Chemical Engineering, Biological Sciences, Pharmaceutical Sciences, or a... ...Where You’ll Work This is a fully remote role. It can be performed effectively from...Remote workFull timeLocal areaFlexible hours$212k - $333.19k
...drug conjugates (ADCs), complex biologics and small molecules. Our goal... ...Director, Global Regulatory Lead - Oncology, where you will be... ...submissions including for Late-Stage assets.Solid working knowledge of... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1...Remote workAssetMinimum wageLocal areaWorldwide$148k - $194.3k
...Atlanta, Raleigh or Boston) or Remote (up to 20% onsite presence)... ...commercial viability of various assets in development.You will be responsible... ...with Integrated Insights Leads from early asset and late... ...ideally specialty pharma and biologic treatmentsDeep expertise in leveraging...Remote workAssetPermanent employmentWork at officeLocal area$212k - $333.19k
...Senior Director, Global Program Lead- Neuroscience in our Cambridge,... ...(s). The GPL defines the asset strategy and leads all development... ...Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT... ...accordance with Takeda’s Hybrid and Remote Work policy.Empowering Our People...Remote workAssetMinimum wageWork at officeLocal area$200k - $290k
...Director/Senior Director of CMC Quality Operations to... ...Operations Location: Remote (U.S.) What You'll Do... ...development of clinical assets and regulatory submissions... ...change controls; lead OOS/OOT and deviation investigations... ...in support of biologic and small molecule...Remote workAssetContract workFlexible hours$170.45k - $243.5k
...Scope:The Global Statistical Lead (GSTATL) for Solid Tumor Oncology... ...planning for solid tumor assets.Responsibilities and Accountabilities... ...g., next gen ADCs, engineered biologics, engineered small molecules).... ...is based in Northbrook, IL. Remote work from anywhere in the US...Remote workAssetWork at officeWork from homeWorldwide$212k - $333.19k
...Leveraging a proven track record of leading at least 3 discovery programs... ...the medicine vision, early asset strategy and managing... ...must include experience with biologics and preferably across multiple... ...hybrid” by Takeda’s Hybrid and Remote Work policy Takeda Compensation...Remote workAssetMinimum wageFull timeLocal areaWorldwide- CSL Behring in King of Prussia, PA seeks a Senior Manager Global Regulatory Affairs CMC—Biological & Non-Biol. Products to lead regulatory strategy and submissions for a dynamic product portfolio. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs...
- CSL, headquartered in King of Prussia, seeks a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs to meet evolving CMC requirements...
- ...This is a client-facing Language Lead position. In addition to... ...team of linguists. This is a remote freelance position open to candidates... ...accounts. Manage language assets, including translation... ...structure and terminology, and CMC technical content. Prior experience...Remote workAssetHourly payFull timeContract workFreelanceWorldwide
$258.68k - $313.46k
...regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products:Develop... ...key areas - Drug Development/CMC/Pharmtox/Biopharmaceutics/... ...site-by-design, field-based and remote-by-design. The model assigned to...Remote workAssetHourly payFull timeSummer workLive inLocal areaFlexible hours$173.2k - $272.6k
...delivering a fully integrated stage-appropriate CMC development and commercialization... ...responsible for advancing the company's biologics portfolio.Correspondingly, the DCT leader... ...impactful manner with proven ability to lead complex discussions, influence stakeholders...Full timeFor contractorsLocal areaFlexible hours$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team, focusing on the development and launch of Biogen's nephrology assets. Your initial focus will be on overseeing a critical asset in clinical development for multiple indications...AssetFull timeTemporary workLocal area
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