CMC Ops Lead, Biologics Process Development & Tech Transfer
Soufflé Therapeutics
Soufflé Therapeutics seeks an Associate Director of CMC Technical Operations to drive development and manufacturing of its pipeline. The role provides technical leadership in ligand/antibody development, scale-up, tech transfer, and regulatory readiness. Collaboration with Research, Quality, and Regulatory is essential to deliver GMP-compliant processes. The ideal candidate has a strong biologics background, experience leading CDMO partnerships, and a track record of delivering late-stage #J-18808-Ljbffr Soufflé Therapeutics
- ...for downstream development of novel modalities... ...as well as lead program(s) with... ...transition by leading CMC team as... ...appropriate downstream processes that support... ..., process transfer, and support of... ...team lead for biologics or complex/hybrid... ...is considered::HybridDepartment:Tech OpsSuggestedFull timeTemporary workLocal areaFlexible hours
- ...oversee external manufacturing for our biologics and gene therapy portfolio, guiding development through commercialization. The role... ...of CMOs, cGMP compliance, and global CMC filings. You’ll drive process optimization, tech transfer, and risk management across global teams...Suggested
$122.25k - $176.58k
Job Title: CMC Demand & Supply LeaderLocation: Framingham... ..., supporting Projects Development and Operations through... ...budget definition.Co-lead Demand & Supply Sub... ...Biochemistry, Molecular Biology, Biotechnology, Biomedical... ...to understand complex processes quickly and act as...SuggestedFull time- Amgen is seeking a Process Development Principal Scientist to lead analytical strategy within Attribute Sciences, partnering with Drug Substance, Drug Product... .... You will guide analytical development, method transfer, and regulatory submissions across internal and contract...SuggestedContract work
$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...SuggestedFull timeTemporary workLocal area$148.5k - $214.5k
Job title: CMC dossier leaderLocation: Framingham, MAAbout the... ...speed up drug discovery and development to find answers for patients... ...roles and responsibilities in leading the preparation of CMC dossiers... ...preparation and development processes.Drive alignment between dossier...Full time$109.6k - $150.7k
...Learn more at and on LinkedIn and X.The Lead Analyst NPI, based in the ADI Wilmington... ...improve New Product Introduction (NPI) processes. This role partners with Business Unit project... ...issues and reduce cycle time from development to release for manufacturing. In the near...Permanent employmentFull timeWork at officeDay shift- Sanofi Inc. in Framingham, MA seeks a CMC Demand & Supply Leader to unify Clinical, CMC, and Development demand into an optimized end-to-end plan across the supply chain. You will partner with Global Project Management, Clinical Development, and manufacturing stakeholders...
- ...project representative to provide scientific and strategic DMPK guidance across our biologics portfolio. You will lead PK/BA/immunogenicity studies, influence discovery and development strategies, and collaborate with multi-disciplinary teams to optimize candidate selection...Remote job
- Job Title: CMC Synthetics Clinical Manufacturing Leader Location... ...communicate sourcing plans. Lead sourcing strategy: internal... ...reinternalization: co-lead process transfer from CDMO to internal pilots... ...engages patients early in drug development and uses their insights to design...Temporary workLocal area
- ...(CRO) teams to ensure development and validation of assays... ...as the IBA project lead on the select programs... ...inaddition to traditional biologics and background... ...experienced in drug development process and regulatory filings... ...Experienced in assay transfer, scientific quality,...Hourly payTemporary workImmediate start
- ...life using design thinking, agile development methodologies, and new smart tech like IoT, automation, and AI. We even... .... THE WORK:As an Oracle WMS Cloud Lead, you will design, configure, and deliver... ...in our reasonable accommodation process. Accommodations made to facilitate...Full timeWork experience placementLive inWork at officeLocal area
$142.5k - $256.5k
...Director, Global Regulatory, CMC will be responsible... ...for patients. Development of regulatory strategy... ...development of regulatory processes and procedures to support... .../MS/PhD in Molecular Biology, Pharmaceutics,... ...aspired to build the leading mRNA technology platform...Permanent employmentFull timeWork at officeWork from home- ...life using design thinking, agile development methodologies, and new smart tech like IoT, automation, and AI. We even... ...Oracle Utilities Integration Lead who brings both the architectural vision... ...participate in our reasonable accommodation process. Accommodations made to facilitate...Full timeWork experience placementLive inWork at officeLocal areaRemote work
$210.9k - $379.2k
...technology, with a diverse pipeline of development programs across various diseases.As an employee... ...is seeking a Global Medical Director to lead medical affairs strategy across our... ...in connection with the hiring process and/or to perform the essential functions...Permanent employmentFull timeWork at officeWork from homeWorldwide$85k - $130k
...fulfilling career.As a Team Leader within our Transfer Agency division, you will be... ...oversight and management of the Transaction Processing Team and maintaining a high standard of... ...and income protection to professional development opportunities and time off, our programs...Full timeWork experience placementWork at officeLocal area$154.4k - $242.55k
...that my employment application process with Takeda will commence and... ...Brand Insights and Analytics Lead, US Oncology is an Associate... ...Unit, supporting the development and execution of brand strategies... ...competitive intelligence in specialty biologics healthcare environment....Minimum wageTemporary workLocal areaRemote work$114.1k - $211.9k
...Translational Biomarker Strategy Lead to serve as the biomarker... ...teams.This role will lead the development and execution of preclinical... ...Lead will partner closely with Biology, In Vitro, In Vivo, Data... ...provided during the application process. Pay equity is a fundamental...Full timeLocal areaFlexible hours- ...of our clients. We provide process development, produce GMP viral vectors,... ...a part of the process that leads to new cures. WORKING AT... ...Manufacturing support for tech transfers Attend Change Control Review... ...BS or MS degree in biology, biochemistry, molecular biology...Hourly payLive inVisa sponsorship
$143k - $214.6k
...profit biopharmaceutical development organization primarily... ...advance novel drug, biologics, and vaccine... ...professionals across regulatory, CMC, and clinical... ...Consolidations Associate Lead will manage all aspects... ...listed below: Enhance FP&A processes, systems, and tools to...Local areaRemote workRelocation packageFlexible hours$100k - $115k
...to support an LNP and RNA Process Development and Technology Transfer team. The successful... ...process development and tech transfer of LNP drug products... ...Management Responsibilities: Lead, manage, and develop a... ...: B.S. degree in biological sciences, chemistry, or biomedical...Full timeMonday to Friday$154.5k - $202k
...Bio Formation Bio is a tech and AI driven pharma company... ...radically more efficient drug development. Advancements in AI and... ...built technology platforms, processes, and capabilities to accelerate... ...headcount. About the Role As Lead Tech Recruiter, you will be...Full timeWork at officeLocal areaRelocation3 days per week- ...Pharmaceuticals is seeking an Associate Director to lead downstream development for emerging modalities, with emphasis... ...purification. You will guide CMC strategy and partner with CDMOs to... ...You will design scalable purification processes, define control strategies, and...
- ...Flagship-founded biotechnology company in Cambridge, MA, seeks a Senior Director of Lipid Nanoparticle (LNP) Formulation & Process Development to lead formulation, process development, and small-scale production for partner and internal programs. The role combines...
$174k - $210k
...in Cambridge, MA for focused technical development and several times per year we gather for... ...disability status. Strategic Partnerships Lead The Strategic Partnerships Lead is... ...exposure to formal teaming and capture processes. Background working with engineering software...Permanent employmentFor contractorsRemote workHome officeFlexible hours$39.5 - $54 per hour
...training of new hires and the development of current employees Keep... ...supplies as necessary Assist with processing of specimens when needed... ...’s degree in a Chemical or Biological science, Histology, Clinical... ...months or more of supervising or leading a team Additional Job...Hourly payTemporary workCasual workRelocation packageMonday to FridayFlexible hoursShift work$82.3k - $220k
## Group Lead - Embedded Systems Technology IIApplyremote type: Onsite Requiredlocations... ...an independent, nonprofit research and development company headquartered in Cambridge, MA.... ...tasks to make new or modified processing hardware usable for development and execution...Full timeWork at officeLocal area$85.6k - $149.4k
...a Senior Technology Product Manager - GTM Enablement and Launch Lead, you will play a critical role in ensuring the successful planning... ...internal readiness and timelines.Visibility, Reporting, and Process ImprovementMaintain launch dashboards and documentation to provide...Full timeWork at office$118.3k - $207.4k
...skills, including customer research, experimentation, roadmap development, and metrics-driven decision-making. Experience translating complex... ...Our Interview PracticesTo maintain a fair and genuine hiring process, we kindly ask that all candidates participate in interviews...Full timeWork at office$175k - $225k
...centered computing. The resulting research and development help to continuously advance government... ...autonomous systems, and advanced sensor processing. This position includes both senior-... ...and the future opportunity to lead a team of engineers. The ideal candidate...Work experience placementCasual workWork at office
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