Sr. Manager, CMC Analytical Development
$150k - $160kFull-time
Veloxis Pharmaceuticals, Inc
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility. Company:
Veloxis Pharmaceuticals, Inc. Job Description: This position provides analytical support of the Company's product portfolio and pipeline from early-stage development through post-approval requirements and works directly with the Company's partners to ensure testing is compliant with Quality, Regulatory, and Company requirements, necessitating a high level of external communication and interaction as well as ability to manage multiple projects. The incumbent works on project teams to drive the growth and development the Company's products, as well as with contract research/development/manufacturing organization (CRO/CDO/CMO) partners on study activities to meet established timelines and provide necessary scientific oversight for outsourced work on method development/re-development, qualification/validation, sample analysis, characterization, data delivery, and reporting. The base compensation range for this role is $150-160K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions." Summary of Key Responsibilities
Veloxis Pharmaceuticals, Inc. Job Description: This position provides analytical support of the Company's product portfolio and pipeline from early-stage development through post-approval requirements and works directly with the Company's partners to ensure testing is compliant with Quality, Regulatory, and Company requirements, necessitating a high level of external communication and interaction as well as ability to manage multiple projects. The incumbent works on project teams to drive the growth and development the Company's products, as well as with contract research/development/manufacturing organization (CRO/CDO/CMO) partners on study activities to meet established timelines and provide necessary scientific oversight for outsourced work on method development/re-development, qualification/validation, sample analysis, characterization, data delivery, and reporting. The base compensation range for this role is $150-160K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions." Summary of Key Responsibilities
- Oversees conduct of all CMC testing (large molecule) at CRO/CDO/CMOs.
- Oversees CMC method (large molecule) development, validation, qualification, and transfers at CRO/CDO/CMOs
- Oversees CMC stability programs at CRO/CDO/CMOs.
- Provides expert review, assessment, and trending of CMC analytical data from CRO/CDO/CMOs.
- Oversees characterization, qualification, and life-cycle management of reference materials.
- Serves as technical lead for CMC analytical testing.
- Manages CMC methods and specifications for release and stability.
- Efficiently communicates project tasks, deliverables, and timelines to external partners, ensuring that critical deadlines are agreed upon and met.
- Authors appropriate documentation in a timely manner to support regulatory filings, including but not limited to IND, IMPD, NDA/BLA, and pre- and post-approval changes.
- Authors, reviews, and/or approves all technical related protocols, SOPs, change controls, and reports, as needed, ensuring delivery of those reports to other Company departments (Manufacturing & Technical Operations, Clinical, Quality Assurance, Regulatory Affairs), external vendors, and/or license partners.
- Supports partners in all activities related to CMC analytical development.
- Assists in the department's successful and efficient execution of departmental/area goals.
- Supports the Quality Assurance department in auditing activities of CRO/CDO/CMOs.
- Prepares for regulatory agency inspections, including pre-approval inspections at the Company's facilities and key contractors' facilities.
- Stays abreast of scientific literature and regulatory guidelines pertinent to CMC analytical development and the therapeutic area(s) of the Company's products.
- BS, MS or PhD in Analytical Chemistry, Biochemistry, or related field.
- 10 years' experience in CMC analytical in pharmaceutical testing environments.
- Extensive knowledge of development validation of CMC analytical methods.
- Extensive knowledge of CMC analytical techniques (e.g., HPLC, ligand binding assays, capillary electrophoresis, CCIT, endotoxin, process impurity methods, peptide mapping, and mass spectrometry).
- Demonstrated expertise in troubleshooting and resolution of CMC related laboratory investigations and deviations.
- Knowledge of requirements and strategy for regulatory submissions related to CMC development; this includes all analytical modules for drug substance and drug product (3.2.S and 3.2.P).
- Demonstrated ability to analyze and transform CMC data (release and stability) into knowledge.
- Extensive knowledge of ICH, market specific guidance, national pharmacopoeia, and industry workgroups related to CMC analytical development.
- Demonstrated ability to assess and act on programs of work to meet business goals.
- Proficiency in Quality procedures (e.g., GMPs, including data integrity).
- Demonstrated consistency in applying and furthering scientific/technical concepts and techniques to resolve scientific/technical issues efficiently and effectively.
- Efficient time management, capable of multi-tasking and prioritization; structured and proactive work approach.
- Excellent interpersonal and communication (verbal and written); effective presentation skills to both internal and external audiences.
- Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.
- Travel Requirements: Approximately 30%
Vacancy posted 6 days ago
Similar jobs that could be interesting for youBased on the Sr. Manager, CMC Analytical Development in Cary, NC vacancy
$150k - $160k
...Health Care, contribute to the development of society by anticipating... ...Description: This position provides analytical support of the Company's... ...as well as ability to manage multiple projects. The incumbent... ...Responsibilities Oversees conduct of all CMC testing (large molecule) at...SeniorFull timeContract workFor contractors- ...JOB DIMENSIONS The Sr. Financial Analyst works across various... ...reconciliation analyses. Data mining and development and implementation of... ...and margin in PowerBI Group managed tool. Develop onboarding FP&A... .../ BS Degree in Finance, Data Analytics, Mathematics / Statistics or...SeniorWork experience placementWork at officeFlexible hours
Arkema
Cary, NC1 day ago $145.4k - $175k
...work that moves the business forward. The product analytics space is being reshaped as AI accelerates product development cycles and raises the stakes for teams trying... ...in software. As the Senior Product Marketing Manager for Pendo's Analytics portfolio, you will own go...SeniorWork at officeRemote workFlexible hours3 days per weekPendo LLC
Raleigh, NC5 days ago- ...experience. The role emphasizes cloud computing technologies, AGILE development, and collaboration across teams. A Bachelor’s degree is... ...in North Carolina. The ideal candidate will possess strong analytical and communication skills, working closely with internal professionals...Senior
Sygna Solutions
Raleigh, NC17 hours ago - ...Labcorp is a leader in diagnostics, drug development and healthcare innovation. Across every... ...lives. Labcorp is seeking a Senior Manager IVD Manufacturing and Operations CDx... ...to effectively perform organizational, analytical, planning, and computer skills Ability...SeniorFull timeTemporary workCasual workInternshipWork at officeRelocation packageFlexible hours
- ...focused on the acquisition, development and commercialization... ..., visit Role The Sr/Executive Director,... ...development, trouble shooting, analytics, technology transfer,... ...contractors, so strong management and interpersonal... ...Experienced in authoring CMC sections for commercial...SeniorContract workFor contractorsRemote work
TG Therapeutics Inc
Morrisville, NC1 day ago - ...Resources Business Partner ( Sr. HRBP ) to join our team. As... ...the HR team, the Sr. HRBP will manage and resolve complex employee... ...compensation, organizational development, employee training, labor law... ...human resources consultative and analytical work and is considered the...Senior
City of Raleigh
Raleigh, NC3 days ago - ...Sampson is seeking an experienced Senior Transportation Project Manager to lead roadway, bridge, and infrastructure projects across... ...Southeast. This position will play a key role in managing the development and delivery of DOT and local government transportation projects...SeniorContract workLocal areaFlexible hours
North American Transportation Management Institute
Apex, NC5 days ago - ...globe.We are looking for a Sr. Director, CMC to join our A-team (hybrid*... ...and related pharmaceutical development activities of drug, biologic... ..., drug product, and analytical development—from early-stage... ...development through Phase 4.Manage and lead direct reports through...SeniorFull timePart timeFor contractorsWork at officeRemote workFlexible hours2 days per week
Allucent
Cary, NC9 hours ago $193.3k - $292k
...Salesforce Life Sciences Senior Manager Our Deloitte Customer team empowers organizations... ...and adoption. You will drive business development activities, craft proposals, and develop... ...Salesforce with MDM, data, or analytics platforms (e.g., OpenData or Reltio for...SeniorPart timeLocal areaVisa sponsorshipDeloitte
Raleigh, NC9 hours ago$189.2k - $372.9k
...focused clients’ overwhelming demand for AI development in new areas, we are expanding our... ...solutions, tools, and services. As a Senior Manager, you will define and execute our... ...teams and delivering complex AI/ML and analytics workloads, including deployment and environment...SeniorPart timeVisa sponsorshipDeloitte
Raleigh, NC9 hours ago$163.4k - $322.1k
...is seeking an experienced Anaplan Senior Manager to support Finance Transformation... ...through financial planning, forecasting, and analytics capabilities. By leveraging next-generation... ...overseeing testing strategy, training development and delivery, and cutover/hypercare for...SeniorPart timeLocal areaVisa sponsorshipDeloitte
Raleigh, NC9 hours ago- ...Mendix is a low-code app development platform: First, what is low-code? Low-code is a visual approach to software development that enables... ...Industries Software is looking for a Senior Content Marketing Manager who lives at the intersection of technical depth and...SeniorFreelanceLocal area
Siemens
Raleigh, NC4 days ago $147.76k - $221.64k
...Caterpillar's Customer Solutions Core Region (CSCR) team is hiring a Senior Account Manager who will drive customer- and outcome-based growth by leading strategic planning, deal development, and commercial execution across the enterprise. In this role, you will partner...SeniorPart timeRelocationFlexible hoursCaterpillar
Cary, NC2 days ago$180.2k - $355.1k
...6/2026. Work you'll do As a Senior Manager on the Organization, Workforce & Change... ...Contributing to practice growth through business development, solution development, thought... ...effectiveness, organization design, workforce analytics, skills strategy, and/or change...SeniorPart timeLocal areaVisa sponsorshipDeloitte
Raleigh, NC9 hours ago- ...Senior Manager, Project Management - Imaging ICON plc is a world-leading healthcare... ...mission to shape the future of clinical development. Job Description Summary... ...priorities effectively. ~ Excellent analytical and problem-solving skills, with a focus...SeniorRemote jobFlexible hours
- ...leading AI-powered maintenance and asset management platform, serving 13,000 customers... ...support high performance. People Strategy Development: Build and execute people strategies... ...Data-Informed Decision-Making: Use people analytics and qualitative insights to diagnose...Senior
MaintainX
Raleigh, NC4 days ago $163k - $322.1k
...to become strategic business partners, manage risk, and unlock new levels of financial... ...agentic AI, RPA, workflow automation, data/analytics, and alliance integrations.Lead design... ...the Finance Operate service catalog.Drive development and operationalization of AI-powered...SeniorPart timeLocal areaVisa sponsorshipDeloitte
Raleigh, NC9 hours ago$231.5k - $272k
...Today, enterprises stitch together separate systems for streaming, analytics, and serving. Each of these systems come with its own latency,... ...systems from a single foundation. As a Staff Product Manager, you\'ll own the vision, strategy, and roadmap for the core streaming...Full timeRemote workConfluent
Raleigh, NC3 days ago$175k - $225k
Hitachi Vantara Corporation is seeking a Senior Product Director for the Utility Market in North America. This remote role involves spearheading innovative sales and marketing strategies for Transformers products. The ideal candidate should have a degree in Engineering ...SeniorRemote workHitachi Data Systems
Raleigh, NC3 days ago$198.7k - $391.6k
...The Health Care Marketing Strategy Senior Manager is a client-facing consulting leader... ...client solutions, and supporting business development across the practiceContribute to and lead... ...transformation engagementsUse advanced analytics and AI-enabled tools to improve efficiency...SeniorPart timeLocal areaFlexible hoursDeloitte
Raleigh, NC9 hours ago$198.7k - $391.6k
...The Experience Design Strategy Senior Manager is a client-facing consulting leader responsible... ...with product roadmaps, user stories, development priorities, and implementation needs.... ...technology stakeholdersExperience using data, analytics, or artificial intelligence tools in...SeniorPart timeLocal areaDeloitte
Raleigh, NC9 hours ago- ...protecting the environment, making sure our food is safe or helping find cures for cancer. Position summary: The Sr Staff Program Manager - Strategic Product Cost Innovation (SPCI) will provide governance across divisional strategic project costing initiatives...SeniorRemote jobFull timeWork at office
$175.73k - $292.88k
...through innovative strategies, advanced analytics, Generative AI, transformative technologies... ..., technology, creativity, and ongoing managed services to solve the biggest problems... ...communities. Learn more. Professional development From entry-level employees to senior...SeniorPart timeLocal areaDeloitte
Raleigh, NC9 hours ago$198.7k - $391.6k
...Pricing and Sales Strategy_ Senior Manager, Strategy, Growth, and Transformation... ...through innovative strategies, advanced analytics, Generative AI, transformative technologies... ...level quantitative analyticsOversee the development of pricing strategies, focusing on concepts...SeniorPart timeLocal areaDeloitte
Raleigh, NC9 hours ago$210k - $240k
...Homes, and Health Care, contribute to the development of society by anticipating the changing... ...like Microsoft365 platform, endpoint management, ITSM platform and management of... ...service delivery and core ITIL processes Analytical problem‑solving and resource optimization...For contractorsLocal areaJobtailor
Cary, NC1 day ago$163k - $322.1k
...to become strategic business partners, manage risk, and unlock new levels of financial... ...production readiness.Lead business case development and value quantification for new platform... ...workflow platforms (ServiceNow), and data/analytics technologies.Product management...SeniorPart timeLocal areaVisa sponsorshipDeloitte
Raleigh, NC9 hours ago$140k - $165k
...Technology (SAT) is part of the Global CMC, Science & Technology... ...the optimization and life-cycle management of Sobi’s clinical and commercial manufacturing and analytical processes across internal and... ...6+ years of experience in the development and manufacturing of small-...SeniorContract workTemporary work- ...Work Flexibility: Hybrid The Manager, Upstream Marketing is a critical role within the... ...business unit, embedded within the Research & Development organization. This role is responsible... ...Financial, Pricing & Performance Analytics Manage pricing strategy and ensure alignment...For contractorsWork experience placementWork at office
Dormont Manufacturing Company
Cary, NC4 days ago - ...powered capabilities and flexible tech stacks, so customers can manage, secure, and recover with confidence. But the real power behind... ...communicate complex information in a clear manner ~ Strong analytic ability and knowledge of Excel to evaluate data, model changes...SeniorLocal areaFlexible hours
N-Able Technologies, Inc.
Morrisville, NC3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr. Manager, CMC Analytical Development. Be the first to apply!
Related searches
- research and development manager Cary, NC
- director of international development Cary, NC
- director leadership development Cary, NC
- franchise development manager (remote) Cary, NC
- leadership development manager Cary, NC
- organisational development manager Cary, NC
- director of web development Cary, NC
- development chef Cary, NC
- development manager Cary, NC
- community development project manager Cary, NC