Cmc Project Leader

8 months ago

Macclesfield, United Kingdom AstraZeneca Full time

**CMC Project Leader - Oncology**

**Macclesfield UK**
- At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person._

**About the Role**

The CMC Project Leader is a key leadership position within Pharmaceutical Technology & Development (PT&D), and reports to the Project Leadership TA Head. The role holder is accountable for strategy & planning, delivery and budget management of the CMC contribution to drug projects in development as well as on market products. The role is critical to the successful development of AstraZeneca’s products and requires leadership, CMC expertise, and eye for business capabilities. The role holder is accountable for the strategy and delivery of the Pharm Tech & Dev contribution to projects.

The CMC Project Leader leads projects from initiation to implementation within agreed constraints of time, budget and quality. The role typically has responsibility for both people and budget. They shape solutions and ensures that business requirements are effectively captured and have a good knowledge of cross-functional drug development, is responsible for risk management, benefits & value management, and as appropriate resolves or advances identified risks and issues.

**Accountabilities**

As a CMC Project Leader, you will lead global Pharmaceutical Teams independently or as part of an overarching program to deliver projects to time, cost, and quality standards and ensuring regulatory compliance, identifying, and managing significant risks to project delivery, and developing associated mitigation plans. You will be encouraged to communicate & influence effectively at different levels in the organization.
- With appropriate support has overall accountability for defining and delivering the pharmaceutical development strategy that delivers effective development, approval, commercialisation and LCM of new medicines.

The key CMC accountabilities include
- The overall development and technical strategy
- The regulatory strategy and documentation for marketing authorisations (incl IND/IMPD)
- For in-market products, the role holder is accountable for the development and delivery of the Post-Approval Manufacturability Strategy & Improvement Plan (PAMSIP).
- Clinical supply chain strategy and plan for phase III (transferred generally at start of ph III)
- Accountable to the GPT for maintaining and delivering all aspects of the pharmaceutical development plan including control of the scope, timing, resources, cost, quality and risk.
- An active member of the GPT, contributing to the development of overall project strategies. Is expected to have credibility and influence within the team in which the role holder is a member.
- Prior to transition of project leadership from iMed projects, work collaboratively with the PhSci project team to provide mentorship and line of sight. Timing of input will be dependent on project status and will be agreed between PhSci and PT&D.

**Essential experience & Abilities**
- Scientific degree or equivalent experience (or equivalent) and a good working knowledge of a CMC organisation.
- A good solid understanding of project leadership approaches within the pharmaceutical industry and experience from working with projects from phase I through commercialisation and LCM. Preferably will have experience from functions outside PT&D.
- Understanding of Regulatory requirements, the evolving landscape and the constraints/opportunities this presents
- Experience of cost management (FTEs and $) of large scale projects
- Proven leadership with enterprise attitude, learning agility, networking and negotiation skills and collaborative approach encouraging of delivery of business objectives
- Demonstrated strong interpersonal and communication skills (credible and persuasive) with ability to set clear direction and objectives for the team and to influence at a senior level in the organisation including Governance groups (GPT/ESPC/LSPC/TALT/Supply Committee and beyond)
- Capable of leading the responsibilities for a diverse range of activities and projects acting as the key sponsor for projects and programmes supporting their project/product portfolio.
- Negotiation and influencing skills in order to influence and contribute to the cross-functional project/product strategies and deliverables
- Ability to develop & implement end-to-end Pharmaceutical strategy across all CMC areas (API, DP, etc.) aligned with the overall GPT strategy and clinical/commercial supply
- Experience of leading multi-disciplinary teams with an ability to ensure accurate structure and team composition for efficient delivery and transition across the value stream
- Experience of managing through complex problems, demonstrating co

  • International Cmc Regulatory Affairs Associate

    8 months ago

    Macclesfield, United Kingdom AstraZeneca Full time

    **About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...

  • Senior Scientific Leader

    1 week ago

    Macclesfield, Cheshire East, United Kingdom CK Group Full time

    Job DescriptionCandidates with a strong background in analytical chemistry and experience in pharmaceutical research are sought after by CK Group for a Senior Analytical Scientist role based in Macclesfield. The successful candidate will lead analytical development activities, develop methodologies, and conduct lab-based experimental work to support project...

  • Senior Scientific Leader

    1 week ago

    Macclesfield, United Kingdom CK Group Full time

    Job Description Candidates with a strong background in analytical chemistry and experience in pharmaceutical research are sought after by CK Group for a Senior Analytical Scientist role based in Macclesfield. The successful candidate will lead analytical development activities, develop methodologies, and conduct lab-based experimental work to support project...

  • Pharmaceutical Research and Development Leader

    18 hours ago

    Macclesfield, Cheshire East, United Kingdom CK Group Full time £26

    About the RoleThis exciting opportunity exists for an experienced analytical chemist to lead the development of analytical methodologies and strategies to support early phase drug product development and clinical supply.You will be responsible for authoring CMC content for regulatory filings, preparing responses to regulatory questions and interpreting...

  • Chemical Development Expert

    1 week ago

    Macclesfield, Cheshire East, United Kingdom CK Group Full time £26

    Overview:CK Group, a renowned pharmaceutical industry leader, is seeking an exceptional Senior Analytical Scientist to join their team on a contract basis for 12 months in Macclesfield.Salary:£26.00 per hour PAYE or £50.00 with the option to increase based on experience.Job Description:The successful candidate will identify and develop analytical...

  • Associate Principal Scientist

    8 months ago

    Macclesfield, United Kingdom AstraZeneca Full time

    **Associate Principal Scientist (Analytical) Senior Project and Technical Lead** AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceutical and the supply of healthcare services. But we’re more than one of the world’s leading pharmaceutical companies. At...

  • Senior Scientist

    1 week ago

    Macclesfield, Cheshire East, United Kingdom SRG Full time

    We are looking for a Senior Scientist - Method Development to join our team at SRG in Macclesfield. As a Senior Scientist, you will be responsible for developing and implementing analytical methodologies to support project progression through early development.The ideal candidate will have a strong understanding of analytical science inputs into early phase...

  • Transformational Project Leader

    1 month ago

    Macclesfield, Cheshire East, United Kingdom Royal London Full time

    Role OverviewWe are seeking a highly skilled Transformational Project Leader to join our Change team at Royal London. This exciting opportunity will enable you to lead a diverse range of projects or small portfolios, all supporting the achievement of the Group strategy effectively and efficiently.About the RoleThe successful candidate will have overall...

  • Analytical Development Expert

    1 week ago

    Macclesfield, United Kingdom CK Group Full time

    Job Summary We are seeking an experienced Senior Analytical Scientist to join our team in Macclesfield. The successful candidate will be responsible for leading analytical development activities, developing new methodologies, and conducting laboratory experiments to support project progression. A BSc, MSc, or PhD in Chemistry or Analytical Chemistry is...

  • Analytical Development Expert

    1 week ago

    Macclesfield, Cheshire East, United Kingdom CK Group Full time

    Job SummaryWe are seeking an experienced Senior Analytical Scientist to join our team in Macclesfield. The successful candidate will be responsible for leading analytical development activities, developing new methodologies, and conducting laboratory experiments to support project progression.A BSc, MSc, or PhD in Chemistry or Analytical Chemistry is...

  • Pharmaceutical Research Specialist

    1 week ago

    Macclesfield, United Kingdom CK Group Full time

    About the Role This Senior Analytical Scientist position involves leading analytical development activities, identifying new methodologies, and conducting lab-based experimental work to support project progression. The successful candidate will have a strong background in analytical chemistry and experience in the pharmaceutical industry. A comprehensive...

  • Pharmaceutical Research Specialist

    1 week ago

    Macclesfield, Cheshire East, United Kingdom CK Group Full time

    About the RoleThis Senior Analytical Scientist position involves leading analytical development activities, identifying new methodologies, and conducting lab-based experimental work to support project progression. The successful candidate will have a strong background in analytical chemistry and experience in the pharmaceutical industry.A comprehensive...

  • Regulatory Cmc Intern

    7 months ago

    Macclesfield, United Kingdom AstraZeneca Full time

    To assist CMCRA in creating, compiling, managing and communicating regulatory knowledge and information within the group. **Major Responsibilities**: Work to establish smooth lines of communication across CMCRA to facilitate full integration of the group. Working with identified preferred knowledge management tools to improve the quality of information in...

  • Pharmaceutical Scientist with Analytical Expertise

    4 days ago

    Macclesfield, United Kingdom CK Group Full time

    About the Role We are seeking a Senior Analytical Scientist to join our team in Macclesfield, UK. The successful candidate will be responsible for leading analytical development activities, developing analytical methodologies, and conducting lab-based experiments. Key Responsibilities: Lead the analytical development activities to support the development...

  • Pharmaceutical Scientist with Analytical Expertise

    4 days ago

    Macclesfield, Cheshire East, United Kingdom CK Group Full time

    About the RoleWe are seeking a Senior Analytical Scientist to join our team in Macclesfield, UK. The successful candidate will be responsible for leading analytical development activities, developing analytical methodologies, and conducting lab-based experiments.Key Responsibilities:Lead the analytical development activities to support the development and...

  • Scientist Lead

    1 week ago

    Macclesfield, Cheshire East, United Kingdom CK Group Full time

    Senior Analytical ScientistEstimated salary: £26.00 - £50.68 per hour, depending on experience and location.About the RoleWe are seeking a highly skilled Senior Analytical Scientist to lead analytical development activities in support of drug product development during early clinical phases.Key ResponsibilitiesDevelop and implement analytical methodologies...

  • Senior Scientist Or Scientist

    1 week ago

    Macclesfield, United Kingdom Ck Group Full time

    CK Group are recruiting for a Senior Analytical Scientist, to join a company in the pharmaceutical industry, based in Macclesfield, on a contract basis for 12 months.Hourly: £26.00 PAYE or £50.Identify and develop the analytical methodologies that support project progression through early development.Conduct lab-based experimental work to generate data to...

  • Process Leader

    6 months ago

    Macclesfield, United Kingdom AstraZeneca Full time

    **Process Leader**: **Introduction to Role**: Are you ready to take on a leadership role within a dynamic and fast-paced manufacturing environment? If so, we have an exciting opportunity for you at AstraZeneca. We are currently seeking Process Leaders for our Packing Department at our Macclesfield campus, the 2nd largest operational site within our global...

  • Senior Analytical Scientist

    4 days ago

    Macclesfield, United Kingdom CK Group Full time

    Job Title: Senior Analytical Scientist We are seeking a highly skilled and experienced Senior Analytical Scientist to join our team in Macclesfield, UK. About the Role This is a contract basis position for 12 months with an estimated salary of £95,280 per annum (£26.00 hourly rate) or £110,416 per annum (umbrella rate of £50.68 per hour). Key...

  • Senior Scientific Development Manager

    4 days ago

    Macclesfield, United Kingdom CK Group Full time

    Job Overview CK Group is recruiting for a Senior Analytical Scientist to join a pharmaceutical company in Macclesfield, UK, on a 12-month contract basis. The role offers an exciting opportunity to lead analytical development activities and contribute to the early clinical phases of drug product development. Salary: £26.00 per hour (PAYE) or £50.68 per hour...