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 5 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... ...interaction as well as ability to manage multiple projects. The... ...ResponsibilitiesOversees conduct of all CMC testing (large molecule) at...SeniorFull timeContract workFor contractors$160k - $175k
...Homes, and Health Care, contribute to the development of society by anticipating the changing... ..., Inc.Job Description:The Senior Manager, Manufacturing Sciences & Technology (MS... ...process robustness, in-process control, and analytical alignment central to the role. The...SeniorFull timeContract work- OverviewColliers Engineering & Design seeks a Senior Project Manager to join its Land/Site Development team in Cary, NC.The Senior Project Manager is... ...interactions.Strong attention to detail with excellent analytical and judgment capabilities.Ability to work independently...SeniorTemporary workWork at officeLocal area
$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... ...integrating Salesforce with MDM, data, or analytics platforms (e.g., OpenData or Reltio for...SeniorLocal areaVisa sponsorship$80 - $97.87 per hour
job summary: Drive high-impact technical initiatives at the intersection of drug development and operational strategy. As a CMC Project Manager, you will take ownership of cross-functional workstreams, maintaining rigorous control over timelines, budgets, and risks...SuggestedHourly payContract workTemporary workWork experience placementResearch Triangle Park, NC29 days ago$180.2k - $355.1k
...09/26/2026. 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...SeniorLocal areaVisa sponsorship$125k - $160k
...sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around... ...Company Veloxis Pharmaceuticals, Inc. Job Description The Senior Manager, Peer-to-Peer Strategy & Engagement is a strategic execution...SeniorWork at officeVeloxis Pharmaceuticals Inc
Cary, NC2 days 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 workSobi
Morrisville, NC14 days ago$110.7k - $218.3k
...avoidance, contracting/procurement, data analytics and project governanceBuild suitable... ...with confidence Help organizations plan, manage and control project cost and schedule through... ...of work productsAssist in proposal development, as requestedActively expand consulting...SeniorContract workLocal area- ...unit established in February 2020 and focused on research, development and commercialization of treatments and patient support... ...what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to support Chiesi’s Global...SeniorHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- ...moments of recognition and connection. We invest in the growth and development of our team members through ongoing learning opportunities,... ...make an impact.SUMMARYQ2 is seeking a Senior Customer Success Manager dedicated to stewarding the success of a portfolio of leading...SeniorFull timeWork visa
$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...SeniorLocal area$198.7k - $391.6k
...Summary The Experience Design Strategy Senior Manager is a client-facing consulting leader... ...with product roadmaps, user stories, development priorities, and implementation needs. Lead... ...stakeholdersExperience using data, analytics, or artificial intelligence tools in consulting...SeniorLocal area$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...SeniorLocal areaFlexible hours$155.63k - $317.88k
...value.What You’ll DoAs a Deloitte Tax Enterprise Architect, Sr. Manager, you will be responsible to help our teams to build enterprise... ...relevant regulations.Instill innovative AI solutions, and advanced development practices across tax technology organizationImplement...SeniorWork at officeLocal areaShift work$198.7k - $391.6k
...Pricing and Sales Strategy_ Senior Manager, Strategy, Growth, and Transformation Our... ...through innovative strategies, advanced analytics, Generative AI, transformative technologies... ...level quantitative analyticsOversee the development of pricing strategies, focusing on concepts...SeniorLocal area$86.63 - $170.72 per hour
...09/26/2026. 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...SeniorFull timeLocal areaVisa sponsorshipDeloitte
Raleigh, NC21 hours ago- ...focused on the acquisition, development and commercialization... ..., visit Role The Sr/Executive Director, Drug... ...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, NC12 hours ago $70 - $85 per hour
...Description Job Title: Senior Project Manager – Operational Readiness Job... ...as Manufacturing, Engineering, Process Development, Supply Chain, and Quality Control. This... ...multiple functions and levels. Strong analytical and problem-solving skills to identify...SeniorContract workTemporary workWork at officeActalent
Holly Springs, NC5 days ago- QA Operations Sr. ManagerAt Guerbet, we build lasting relationships so that to enable... ...dedicate 10% of our revenue to Research & Development such as to improve the diagnosis,... ...WE ARE LOOKING FORThe QA Operations Sr. Manager will be operating in full compliance with...SeniorLocal area
- ...mission to shape the future of clinical development. Project Lead As a Project Leader at... ...you will be responsible for guiding and managing medical communications and publication projects... ...to stakeholders and team management and sr management as appropriate. Your...SeniorRemote jobFlexible hours
$90k - $125k
...Extreme team.About the Role The Senior Field Onboarding & Sales Development Manager is responsible for executing and scaling onboarding and... ...leveraging the powers of machine learning, artificial intelligence, analytics, and automation. Over 50,000 customers globally trust our...SeniorFull time- Milton Hershey School, a cost-free pre-K through 12th grade residential school, is seeking a Youth Development Specialist in the Education, Training & E-Learning department. This role supports students’ academic, social, and emotional growth through mentoring, small-group...
Milton Hershey School
Cary, NC3 days ago $146.2k - $189.2k
...member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our... ...consumers and use case teams with technical execution, and manage platform engineering teams composed of internal resources and...SeniorFull timeFor contractorsLocal area$46.92k
...environment that fosters students' academic, emotional, and social development so they can reach their full potential. Responsibilities include: Providing daily supervision and mentorship Managing household routines and student schedules Administering...Full timeWork from homeRelocationRelocation packageFlexible hoursWeekday workMilton Hershey School
Cary, NC1 day ago- ...Job Description Job Description Description: Senior Project Manager — Residential Development Practice Area WithersRavenel | Cary, NC | Hybrid WithersRavenel is seeking a Senior Project Manager to join our growing Residential Practice Area ! This is a high...SeniorLocal areaShift workWeekend workAfternoon shift
WithersRavenel
Cary, NC22 days ago $127.5k - $150k
...Project Controls (Planning), Project & Development ServicesJob Description SummaryThis senior... ...project cost lead and project controls manager to develop a plan for the long-term... ...Must have exceptional organizational, analytical and problem-solving. Must have the ability...Minimum wageFull timeImmediate startFlexible hours$171.6k - $338.3k
...that trusted Private Equity partner and apply to this Senior Manager role today! Recruiting for this role ends on 9/18/2026 Work you... ...outcomes for our communities. Learn more. Professional development From entry-level employees to senior leaders, we believe there...SeniorLocal areaVisa sponsorship$163.4k - $322.1k
...ever-changing threat landscape. Through powerful solutions and managed services that simplify complexity, we enable our clients to... ...transition to operations.· Driving practice growth through business development, proposal development, alliance relationships, technical...SeniorLocal areaRemote workVisa sponsorship- ...position is ideal for experienced facilities management professionals to join the Facilities &... .... Direct hiring, training, and development of facility staff, fostering a culture... ...operations, and building management; strong analytical, problem-solving, and technical...SeniorHourly payFull timeContract workTemporary workInternshipLocal areaFlexible hours
Align Technology
Morrisville, NC28 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
- development director Cary, NC
- director of international development Cary, NC
- professional development manager Cary, NC
- senior manager product development Cary, NC
- development manager Cary, NC
- community development project manager Cary, NC
- research and development chef Cary, NC
- director of web development Cary, NC
- director learning & development Cary, NC
- director leadership development Cary, NC