CMC Analytical Science Lead - Late-Phase Programs
BioSpace
Moderna in Norwood, MA is seeking a Senior Manager – Analytical Sciences & Technology (AS&T) – CMC Lead to provide technical expertise and program support for analytical method activities supporting late‑phase development and commercial programs. This individual contributor role will oversee qualification, validation, transfer and lifecycle strategies for analytical methods across a global network and interact with regulatory authorities to ensure compliance and timely approvals. #J-18808-Ljbffr BioSpace
- A biopharmaceutical innovator in Norwood, MA, is seeking a Senior Manager for Analytical Sciences & Technology. This role involves leading analytical qualification strategies and managing methodologies throughout the product lifecycle to support regulatory submissions...SuggestedFull time
$238k - $374k
...and the resources of a leading pharmaceutical company.... ...Objective: As AIRx Biologics Program Lead, you will own the... ...in a model where the science, not the governance... ...scientific, clinical, CMC, and commercial considerations... ...), purification, analytical characterization, and early...SuggestedMinimum wageTemporary workLocal areaRemote work$155k - $175k
Senior Manager, Program Management & Drug Substance Lead Join us in tackling autoimmune disease... ...at its root. At Vor, science can do more than manage symptoms... ...ensure alignment across CMC, Quality, Regulatory,... ...Problem Solving : Strong analytical mindset with the ability...SuggestedWorldwideFlexible hours$183.8k - $330.3k
Director, Robotics Implementation Program LeadSkip to main... ...Robotics Implementation Program Lead page is loaded## Director, Robotics... ...the robotics strategy across CMC manufacturing network for Clinical... ...Engineering, Robotics, Computer Science, or related technical...SuggestedPermanent employmentWork at officeWork from home- BioSpace is seeking an Associate Director, CMC Analytical Development in Boston, MA. This role involves leading analytical method development for small molecules in a hybrid work environment. The ideal candidate will have a Ph.D. in Analytical Chemistry and extensive experience...SuggestedContract workFlexible hours
$202k - $215.6k
Beeline Medicines, located in Durham, North Carolina, is seeking an Associate Director for CMC Analytical Development specializing in small molecule drugs. This senior role requires leading the development and validation of analytical methods, ensuring compliance with...$89.9k - $143.8k
BioSpace is looking for a candidate responsible for enabling efficient analytical execution across CMC Development programs. This role involves strategic planning, stability study management, and digital operations support. You will collaborate across various functions...$142.5k - $256.5k
...Director, Global Regulatory-CMC will be responsible for... ...authority guidelines Lead Regulatory CMC... ...Manufacturing, Quality and Process/Analytical Development groups... ...and impact on internal programs Here’s What You’ll... ...have been recognized as a Science Magazine Top Biopharma...Permanent employmentWork at officeWork from home$235k - $285k
Halozyme Hypercon in Boston is looking for a Senior Director, CMC Technical Lead to drive the development and implementation of scientific, technical, and regulatory strategies for biologics programs. This role will involve leading cross-functional teams, ensuring alignment...$394.5k - $423.1k
Kailera Therapeutics in Boston is looking for a Senior Vice President of Program Leadership to oversee biopharmaceutical programs from late-stage development to regulatory approval. This role requires exceptional leadership to drive integrated program strategies and milestones...$212k - $333.19k
...Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human... ...on regulatory positions, to set programs on course for regulatory success Proven... ...preferred, including expertise with proposing science‑based, data‑driven regulatory positions...Full timeTemporary workLocal areaWorldwideNight shift$293k - $358k
.... Our breakthrough science enables the identification... ...multiple discovery programs advancing toward... ...5 and is backed by leading life sciences... ...clinical, regulatory, CMC, medical affairs,... ...programs across multiple phases and understands the... ...role on a late‑stage asset through...$196k - $269.5k
...maintains its roots as a science‑based start‑up and pushes... ...Director, Global Indication Lead, Rheumatology. In this... ...asset in one or multiple late‑stage clinical development programs which include for example... ...management experience. Strong analytical skills with the ability...Temporary workWork at office$84.4k - $113k
...The American Heart Association has an opportunity for a Sr. Program Lead, Professional Education, Cardiovascular‑Kidney Metabolic Health... ...Association will drive breakthroughs and implement proven solutions in science, policy, and care for healthier people and communities. The...Full timeWork experience placementWork at officeLocal areaWork from homeNight shift$130k - $230k
Statistical Programming Lead, Clinical Data Management, R&D, Orion Corporation... ...oncology-focused Data Sciences function and provide strategic... ...development programs across Phase I-III clinical development.... ...automation frameworks, and modern analytics technologies within the...- ...Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and... ...role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment... ...proven ability to manage cross-functional programs in a regulated environment. #J-18808-Ljbffr...
$147k - $167k
Praxis Precision Medicines, Inc. is seeking a Senior Manager, Analytical Sciences - Commercial to lead analytical strategies for commercial products. This position involves overseeing compliance and quality during the product lifecycle and managing analytical execution...Remote job- A leading educational institution is seeking an Associate Director for their In Person Master of Science in Bioethics Program. This role involves academic leadership, program oversight, and admission management while supporting diverse learners' career development. Ideal...
- ...is seeking an Energy Efficiency Analyst focused on data, analytics, automation, and program strategy. This role supports electric and natural gas... ...customer segments and jurisdictions. Responsibilities include leading program reporting, building dashboards, and driving data...
- The Institute for Protein Innovation (IPI) in Boston, MA, seeks a senior neuroscience program manager to bridge science and operations within the Neuroscience team. You will organize scientific workshops, drive project execution, coordinate cross-functional collaborations...
- Stratacuity: Proven Scientific Placement is seeking a Senior Scientist in Analytical Development for a Boston-based client to advance radioligand therapies for cancer patients. In this role, you will lead the development of analytical methods to ensure GMP readiness while...
- Responsibilities Lead development and implementation of regulatory strategies for pure device... ...management. Maintain and communicate CMC/quality guidance and regulations (Human Factors... ...files, post-approval submissions); strong science-based, data-driven regulatory positions...Night shift
- ...Operations Responsibilities Lead the MS&T team to support effective... ...management for Convergent’s late stage assets Represent CMC matters within Convergent’s Program Teams. Provide strong leadership... ...degree in engineering or life sciences. Minimum 12+ years experience...Work at office2 days per week3 days per week
- Moderna is seeking a Director, Robotics Program Implementation Lead to shape and execute the robotics strategy across CMC manufacturing network for Clinical and Commercial... ...’s degree in Engineering, Robotics, Computer Science, or related technical discipline. 10+ years...
- ...within 50 miles of the corporate office. The role provides oversight of assigned pharmacy programs and works with partners to implement and improve them. The incumbent will lead program SME activities, monitor outcomes, ensure compliance, educate stakeholders, and drive...Work at office
$150k - $176k
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers... ...and interpreting data, investigating analytical problems and working with clients to... ...data integrity. Experience in executing phase appropriate method qualifications and validations...Contract work- Raven (RA Ventures) in Boston is looking for a Principal Scientist in Analytical Chemistry to develop and implement analytical methods for the characterization of oligonucleotide therapeutics. The ideal candidate will have a PhD in chemistry or related field and significant...
- UKG (Ultimate Kronos Group) is seeking a Lead Economist in Boston, Massachusetts, to provide strategic guidance in workforce and labor market analytics. You will connect insights from labor economics and macroeconomic trends to influence company strategy and product innovation...
$195k - $275k
A biotechnology company based in Boston is seeking a Lead Statistician to lead statistical efforts for clinical programs. This role involves significant contributions to regulatory submissions and overall data strategy, along with the authorship of crucial statistical documentation...- ...candidate will possess a Ph.D. or Master's in Economics or Finance with extensive experience in the field. This role requires strong analytical skills and knowledge of statistical software, including STATA, R, SQL, and Excel. Telework options are available, making this a...Remote workFlexible hours
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