CrawlJobs Logo

CMC Manager

alliancemedical.co.uk Logo

Alliance Medical Ltd

Location Icon

Location:
United Kingdom , Guildford

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

50000.00 GBP / Year

Job Description:

We have a new opportunity for a Chemistry, Manufacturing, and Controls (CMC) Manager to join our Radiopharmacy team.

Job Responsibility:

  • Support current and new radiopharmaceutical development projects by planning and implementing local CMC activities with a close collaboration in cross-functional teams
  • Work to develop and execute local CMC strategies aligned with business objectives and regulatory requirements from product development to the commercialisation phases
  • Assist in the implementation & maintenance of production processes and quality control testing, writing, and updating GMP documents and ensuring compliance with cGMP and assisting in document reviews and approvals by supporting the quality assurance workflow
  • Hold responsibility for reporting the progress to update the contractors or performing on site visits as appropriate

Requirements:

  • University degree in pharmaceutical sciences, chemistry or related scientific discipline
  • Strong understanding of cGMP regulations and regulatory requirements for radiopharmaceuticals
  • At least 2 years of radiopharmaceutical industry experience in production or quality control and quality assurance
  • Experience in technology transfer projects
  • Ability to identify and solve complex problems
  • Ability to think out of the box and challenge current CMC development strategies
  • Being a team player with good communication skills
  • Willing to travel in Europe (max. 10%)
  • Willing to work in a remote team
What we offer:
  • 5 weeks holiday
  • Discounted private health insurance
  • Pension plan

Additional Information:

Job Posted:
March 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for CMC Manager

Client Engagement Manager, CMC

Serve as a single point of contact for CCS (Connectivity Car Service) and Mobili...
Location
Location
United States , Costa Mesa
Salary
Salary:
103170.00 - 158873.00 USD / Year
haeaus.com Logo
Hyundai AutoEver America
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree or higher in a related field
  • 5 + years of experience in a similar role such as client relationship/ key account management, preferably in the telematics, IT or automobile industry.
  • Consulting experience at a Big4 consulting company, highly desirable
  • Understanding of telematics services, fleet management, and connected vehicle solutions preferred.
  • Telecommunications experience preferred, with broad knowledge of various telecommunication products, services, networks, carriers, rate plans, contracts, and invoices
  • Ability to solve practical problems and deal with a variety of situations.
  • Ability to interpret difficult instructions, derive valid conclusions, and recommend reasonable courses of actions within the scope of the position.
  • Well organized with ability to pay close attention to details.
  • Strong interpersonal skills.
  • Able to collaborate effectively with cross-functional teams.
Job Responsibility
Job Responsibility
  • Serve as a single point of contact for CCS (Connectivity Car Service) and Mobility service-related inquiries and requests from clients and partners.
  • Facilitates and lead new service-related contract development / amendments with clients, HMG affiliates and partners.
  • Engage in all aspects of client and partner interactions, collaborate with the Procurement team to manage vendor contracts and relationships, creation/negotiation with client companies, coordinate with all internal departments for client proposal creation, and provide consulting service to client companies.
  • Lead various projects related to account management, client service, and partner management.
  • Create/manage customer pricing model align with company's strategic direction
  • Create/manage wireless usage forecast model based on new services and vehicle volume.
  • Manage subordinate Business Analysts, as applicable
  • Staying abreast of service implementation and business operation status, keep clients informed and stay up to date with their connectivity service status
  • Functions as a key advocate for Client Business Units (CBUs)
  • Serve as a single point of contact for connectivity service-related inquiries and requests from clients
  • Fulltime
Read More
Arrow Right

CMC Project Management Specialist

Location
Location
United States
Salary
Salary:
Not provided
enveda.com Logo
Enveda
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience with CMC project management in the biotech or pharma industry, specifically focusing on drug substance and drug product development
  • Experience leading cross-functional teams
  • Flexibility, adaptability, and resourcefulness
  • Willingness to work occasional early morning or late evening meetings to accommodate different time zones
  • Experience managing external CROs and CDMOs
  • Fulltime
Read More
Arrow Right

CMC Development Manager

As a CMC Development Manager, you'll take full ownership of CMC (Chemistry, Manu...
Location
Location
Sweden , Stockholm
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • MSc or PhD in Pharmaceutics, Chemistry, Chemical Engineering, Biology, or related field
  • 5+ years of experience in pharmaceutical formulation, process development, or CMC project management
  • Deep understanding of API characteristics, QbD principles, and GMP/ICH standards
  • Proven ability to lead cross-functional CMC workstreams and manage external partners (CMOs/CDMOs)
  • Strong experience in global regulatory submissions (EU
  • US is a plus)
  • Excellent technical writing, communication, and stakeholder management skills
  • Experience in lean or virtual pharma models and post-approval lifecycle management preferred
  • Curious, proactive, and collaborative - able to thrive in an agile, fast-moving international environment
Job Responsibility
Job Responsibility
  • Lead the end-to-end execution of CMC projects for topical and oral solid dosage forms — from formulation and process design to scale-up and lifecycle management
  • Translate API properties into formulation and process design criteria
  • Develop, optimize, and troubleshoot robust formulations and manufacturing processes
  • Oversee scale-up, validation, and tech transfer activities with CMOs and CDMOs
  • Author and review CMC documentation including development reports, process descriptions, and validation summaries
  • Own and ensure scientific integrity of CTD Module 3 content, supporting global submissions and lifecycle variations
  • Partner with Regulatory Affairs to define submission strategies, timelines, and responses
  • Drive cross-functional alignment with QA, RA, Supply Chain, and CMOs to ensure timely and compliant CMC delivery
  • Manage CMC project plans, risk registers, and key milestones for assigned product portfolios
What we offer
What we offer
  • Opportunity to create, grow, and encourage
  • Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
  • Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
  • Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
  • Very positive work environment in a dynamic, international, and motivated team
  • Start-up spirit while being a part of the large international organization with strong values
  • Fulltime
Read More
Arrow Right

Senior Global CMC Manager (Development & Lifecycle)

Karo Healthcare, a dynamic and growing personal-care retail company, is all abou...
Location
Location
Sweden , Stockholm
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in Life Sciences
  • Strong understanding of regulatory requirements and applicable legal frameworks for pharmaceutical products
  • Proven CMC expertise covering the full product lifecycle, including post-approval development and manufacturing-related changes
  • Extensive experience in variation management, including the development and execution of regulatory and CMC strategies
  • Experience with EU regulatory procedures (primarily national, as well as DCP and MRP), with exposure to additional markets considered an advantage
  • Demonstrated experience working at the interface between Regulatory CMC, R&D CMC, and Manufacturing for commercialised pharmaceutical products
  • Hands-on experience with CMC Module 3 authoring, review, and lifecycle maintenance
  • Solid understanding of pharmaceutical manufacturing processes, formulation principles, APIs, and CMO-based supply models
  • Proven ability to work cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Commercial functions, and external partners
  • Experience interacting with regulatory authorities and maintaining effective professional relationships
Job Responsibility
Job Responsibility
  • Act as global CMC Module 3 owner throughout the product lifecycle, ensuring scientific consistency and alignment with the actual manufacturing processes, formulation, APIs, control strategies, and implemented post-approval changes
  • Manage and maintain the CMC (Module 3) components of global and local dossiers, including technical preparation and compilation of CMC documentation to support regulatory submissions and lifecycle maintenance, with particular responsibility for legacy products
  • Ensure timely implementation of approved CMC changes within defined scope, including verification that Module 3 documentation and internal systems reflect Health Authority approvals
  • Assess and lead regulatory CMC evaluation of proposed changes, including technical impact assessment, variation classification, and identification of required documentation in alignment with applicable EU and relevant market requirements
  • Review and approve regulatory CMC documentation for submissions and lifecycle changes in compliance with applicable regulatory requirements and internal regulatory information and document management systems
  • Initiate and maintain CMC-related regulatory events and documentation within the regulatory information management system (e.g., Veeva RIM) in accordance with internal procedures
  • Maintain a current understanding of relevant CMC-related regulations, guidelines, and standards, as well as established and emerging manufacturing and development practices applicable to commercialised pharmaceutical products
  • Lead CMC strategy development for assigned products across development and lifecycle phases, providing aligned CMC input to regulatory strategy discussions, technical risk assessments, gap analyses, and the evaluation and implementation of lifecycle changes
  • Apply in-depth knowledge of CMC Module 3 as a practical lifecycle tool to support and drive technical and regulatory decision-making related to manufacturing and post-approval development activities
  • Act as a technical and regulatory CMC counterpart towards manufacturing CMOs, developing a sound understanding of their manufacturing operations and providing appropriate scientific input, guidance, and challenge as required
What we offer
What we offer
  • Opportunity to create, grow, and encourage
  • Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
  • Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
  • Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
  • Very positive work environment in a dynamic, international, and motivated team
  • Start-up spirit while being a part of the large international organization with strong values
  • Fulltime
Read More
Arrow Right

CMC Project Management Specialist

Join Enveda as a CMC Project Management Specialist in a remote capacity and help...
Location
Location
United States
Salary
Salary:
95000.00 - 115000.00 USD / Year
enveda.com Logo
Enveda
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S./M.S./Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar degree
  • 1-2+ years of CMC project management experience in biotech or pharma, with exposure to drug substance and drug product development
  • Ability to manage cross-functional projects and communicate technical details clearly
  • Experience working with external CROs and CDMOs
Job Responsibility
Job Responsibility
  • Lead cross-functional planning and execution of CMC development activities across drug substance and drug product
  • Partner with internal and external teams to define and track development strategies, timelines, and deliverables
  • Oversee and monitor external CRO and CDMO activities, including planning, communication, and batch execution timelines
  • Develop and manage detailed CMC project plans, ensuring timely delivery through proactive communication and follow-up
What we offer
What we offer
  • 90% Medical, Dental, Vision
  • 401k Match
  • Flexible PTO
  • Adoption Assistance
  • Fulltime
Read More
Arrow Right

Cmc project manager i eds

ICON is looking for a CMC Project Manager I to join our Accelerated Pharmaceutic...
Location
Location
United States , San Antonio
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A minimum of 1 year experience in clinical, laboratory or project management role
  • Background in project management, preferably in a pharmaceutical setting
  • Familiarity with GMP regulations and compliance requirements
  • Excellent communication and interpersonal skills
  • Ability to effectively manage resources and prioritize tasks to meet project deadlines
  • Detail-oriented with strong organizational and problem-solving abilities
  • Bachelor or advanced degree in a relevant scientific field preferred, e.g. medicinal chemistry, organic chemistry, pharmaceutical sciences
Job Responsibility
Job Responsibility
  • Lead and manage multiple CMC projects from early development through commercialization
  • Coordinate cross-functional teams, including Analytical, Formulation Development, Manufacturing, Regulatory, and Quality Assurance
  • Review and authoring of relevant method validation, pharmaceutical analysis, QC reports and other relevant GMP documentation and deliverables
  • Develop and maintain detailed project plans, timelines, and risk assessments
  • Ensure compliance with global regulatory requirements, including FDA, EMA, and ICH guidelines
  • Act as the primary liaison between clients, internal teams, and third-party vendors to ensure alignment and timely execution of project deliverables
  • Work with planning to ensure that appropriate resources are available to complete the study to timeline
  • Proactively identify and address potential project risks, implementing effective mitigation strategies
  • Provide clear, timely, and professional communication to stakeholders regarding project progress, milestones, and potential challenges
  • Monitor project budgets and resource allocation to ensure efficient and cost-effective project execution and draft change order budget when scope changes occur
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Read More
Arrow Right

Regulatory Program Manager

Looking to oversee Regulatory Programs that could revolutionize the future of me...
Location
Location
France , Paris
Salary
Salary:
Not provided
proclinical.com Logo
Proclinical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Project management experience in the pharmaceutical industry
  • Strong understanding of CMC activities and interactions with regulatory and industrial teams
  • Ability to coordinate cross-functional teams
Job Responsibility
Job Responsibility
  • Leading product lifecycle management projects
  • Coordinating CMC, Regulatory, Supply, and Industrialization functions
  • Monitoring project milestones and cross-functional dependencies
  • Facilitating core team meetings, steering committee meetings and progress reporting
Read More
Arrow Right

Regulatory CMC Project Manager

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
United States
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management)
  • 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls)
  • Strong project management skills with a track record of managing complex projects and meeting deadlines
  • Excellent organizational and communication skills
  • Excellent time management abilities
  • Proficient in Microsoft Office Suite
  • Proven experience with project management software ie. Smartsheet
  • Strong communication and interpersonal skills
  • Ability to work collaboratively in a fast-paced, dynamic environment
  • Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones
Job Responsibility
Job Responsibility
  • Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions
  • Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements
  • Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed
  • Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards
  • Health Authority Engagement: Support the preparation of materials for health authority engagements
What we offer
What we offer
  • Flexibility of working remotely
  • Part of a supportive and dynamic team
  • Supportive and inclusive environment
  • Opportunities for career growth
  • Flexible work arrangements
  • Diverse and global client exposure
  • Learn from experts
Read More
Arrow Right