CMC Statistics Director
Scorpion Therapeutics
GENERAL SUMMARY: The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for applying statistical sciences across the product lifecycle, including process development, analytical development, manufacturing, process validation, continued process verification (CPV), stability, quality control, and regulatory submissions. Establishes and leads the CMC Statistics capability and partners with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to drive adoption of statistical best practices (including DOE), process monitoring, and manufacturing data analytics. Key Duties And Responsibilities: Provide strategic statistical leadership across the CMC lifecycle. Establish and lead a CMC Statistics Center of Excellence (standards, governance, methodologies, best practices). Lead statistical work for characterization, optimization, robustness studies, technology transfer, and lifecycle management. Apply DOE for development, optimization, and control strategy development. Implement statistical approaches for PPQ, CPV, SPC, and process capability monitoring. Support analytical method development/validation/lifecycle management with sound study design and analysis. Support stability programs, shelf-life estimation, comparability, and global regulatory submissions. Serve as SME for exploratory data analysis, outlier assessment, regression, multivariate, and predictive modeling. Support investigations, deviations, CAPAs, quality risk assessments, and troubleshooting via quantitative analysis. Drive adoption of advanced analytics, digital solutions, and ML/AI-enabled statistical approaches. Author/review/defend statistical content for regulatory submissions and health authority interactions. Develop and deliver statistical training programs. Monitor emerging trends/technologies in CMC statistics and pharmaceutical manufacturing analytics. Knowledge And Skills: Expertise in statistical methodologies for pharma development/manufacturing/quality/regulatory. Strong knowledge of DOE, multivariate analysis, regression, process capability, SPC, and process validation. Understanding of CPV, PPQ, commercial manufacturing monitoring, and lifecycle verification. Knowledge of analytical method validation, stability analysis, shelf-life estimation, and comparability. Proficient with JMP, Minitab, SAS, R, Python, and other advanced analytics tools. Understanding of FDA/EMA/ICH/global CMC statistical expectations. Knowledge of data integrity principles (ALCOA+). Leadership and change management skills; strong communication across technical and executive audiences. Education And Experience: Ph.D. (10+ years) or M.S. (12+ years) in Statistics/Biostatistics/Industrial Engineering/Applied Mathematics/Data Science or related quantitative discipline. Demonstrated CMC development/process validation/manufacturing/quality/regulatory submission experience in pharma/biotech. Preferred: biologics/cell & gene therapy/small molecules/combination products experience. Preferred: establishing statistical best practices/governance/capability-building in regulated environments. Preferred: advanced analytics, machine learning, digital manufacturing, AI-enabled solutions. Strongly preferred: support for global regulatory inspections, responses, and health authority interactions. #J-18808-Ljbffr Scorpion Therapeutics
$193.1k - $289.7k
Job DescriptionGENERAL SUMMARY:The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the application of statistical sciences across the product lifecycle, including process development, analytical development, manufacturing, process...SuggestedFull timeSummer workRemote workFlexible hours2 days per week$195k - $330k
...valued, seen, and heard.How you’ll make an impact:Drive end-to-end CMC program management for mid to late-stage programs, including... ...with 10+ years (Ph.D.) or 15+ years (M.S.) of CMC experience; Sr. Director level requires commensurate additional experience and...Suggested$228k - $330k
...platforms to create truly novel and potentially transformative treatments.Position Summary:We are seeking an Executive Director or Vice President, CMC (Chemistry, Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution...SuggestedContract work$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...SuggestedFull timeSummer workRemote workFlexible hours2 days per week$202.13k - $336.88k
...technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary As the Senior Director, Early Phase CMC Medicine Research Leader you will ensure the successful CMC delivery of GSK's early phase portfolio (Rx and Vx) through...SuggestedLocal area$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...Full timeTemporary workWork at officeLocal areaFlexible hours$154.4k - $242.55k
...changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: With minimal supervision, develops...Minimum wageTemporary workLocal areaRemote workWorldwide- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality...Full timeSummer workRemote workFlexible hours2 days per week
$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage CMC strategy that turns precision radioconjugate science into first-in-human reality? As Associate Director, CMC Lead, you will steer development across a portfolio of...Hourly payTemporary workBoston, MA27 days ago$173k - $285.33k
...and improving patient outcomes. What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will be an integral part... ...Sets You Apart Quality by Design : Experience applying statistical design and analysis of experiments; experience with...Enanta Pharmaceuticals
Watertown, MA21 days ago$170k - $220k
Associate Director, Regulatory CMC - Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular...Full timeTemporary workRemote workFlexible hours$170k - $195k
Description Of Role Centessa’s CMC group is currently seeking an (Associate) Director of Drug Product within the CMC group to support our early stage programs. The successful candidate will have a demonstrated track record of designing high performance nonclinical and...Full timeContract work- Responsibilities: Define and execute the IT solutions roadmap for CMC digital transformation. Oversee implementation and lifecycle... ...transactional lab run data, DOE/batch execution data, and derived statistical/trending outputs. Standardize/structure process recipe data (...Flexible hours
$167k - $300.7k
The RoleCMC is seeking a dynamic and experienced Director, CMC Stability to lead an end-to-end stability function spanning non-clinical-... ...with Quantitative Sciences, oversee stability data trending, statistical analysis, expiry assessments, and stability reviews to identify...Permanent employmentFull timeWork at officeWork from home$153k - $281.6k
...assays for preclinical and clinical sample analyses.Collaborate cross-functionally with internal stakeholders (medical, operations, statistics, regulatory) and external partners (CROs, academic institutions) to ensure biomarker validation and successful integration into...Flexible hours$193.5k - $338.8k
...the fourth consecutive year. Verve is headquartered in Boston, Massachusetts.Purpose:The Project Statistician at the Director level provides statistical leadership in multiple dimensions including:Provides technical leadership and expertise in initiating and implementing...Local areaFlexible hours$180k - $195k
Associate Director, Quality Assurance - CMC Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated...- Director/Associate Director, Cell Therapy CMC & Manufacturing We are seeking a highly experienced and visionary leader of CMC & Manufacturing to lead our cell therapy development programs. The successful candidate will help lead CMC strategy, manage process development...
- Vertex Pharmaceuticals Incorporated is seeking an Associate Director to lead CMC Quality Compliance and Inspection Readiness. You will drive inspection readiness for external operations, collaborate across functions, and guide risk assessments and CAPA closures to sustain...Remote work
- Centessa Pharmaceuticals in the US is seeking an (Associate) Director of Drug Product within the CMC group to support early stage programs. Lead external CROs/CDMOs and oversee nonclinical formulation development for NCEs, with hands-on manufacturing experience across oral...
- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime type: Full timeposted on: Posted... ...to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise...Contract workRemote work
- ...Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development. This role combines scientific expertise...
$170k - $233.75k
About This Role:As the Associate Director of Data Science & AI, you will spearhead the development and implementation of cutting-edge... ...Required Skills:Master's or PhD in Data Science, Computer Science, Statistics, Mathematics, Engineering, Economics, or a related...Full timeTemporary workLocal area- Associate Director, CMC Product Development - Small Molecule About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune...Contract workLocal areaImmediate start2 days per week
$235k - $285k
...complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works...Temporary workLocal area- Vertex Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface...
- Amylyx Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-to-end quality oversight of clinical and... ...GMP/GDP standards. The role involves authoring and reviewing IND CMC submissions, managing quality systems, supporting regulatory...Remote job
$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...Permanent employmentFull timeWork at officeWork from home$180k - $220k
...Description Job Description Description: POSITION SUMMARY: The Director of Platform Architecture owns the technical design of the... ...suitability for employment, verify identity, and maintain statistics on applicants. ACCOMMODATION FOR APPLICANTS WITH DISABILITIES...Work at officeLocal areaBriefly
Boston, MA10 days ago- ...Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule products Plays a key leadership role within S&T PPG...Full timeLocal area
AbbVie Inc.
Waltham, MAa month ago
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