Cmc Project Leader

2 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

    4 weeks 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...

  • International Cmc Regulatory Affairs Associate

    4 weeks 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...

  • Associate Principal Scientist

    1 month ago

    Macclesfield, United Kingdom AstraZeneca Full time

    We are offering an exciting role as an **Associate Principal Scientist** **in Process Chemistry**, where you will deliver **innovative synthetic organic chemistry solutions **and **lead vibrant teams of scientists** in order to** drive development projects** **The Company - AstraZeneca**: AstraZeneca is a global, innovation-driven biopharmaceutical company...

  • Analytical Associate Principal Scientist

    4 weeks ago

    Macclesfield, United Kingdom AstraZeneca Full time

    **Analytical Associate Principal Scientist - Peptides/Oligonucleotides**: AstraZeneca is a global, biopharmaceutical company where we not only focus on the discovery, development and delivery of life-saving medicines to patients but believe in sustainability and are determined to minimise the impact of our work on the environment. We are proud to be a great...

  • Process Leader

    1 month 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...

  • Process Leader

    1 month 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...

  • Project Lead

    4 days ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects. Due to the ongoing growth, they are...

  • Project Lead

    2 weeks ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects.  Due to the ongoing growth, they are...

  • Project Lead

    5 days ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects. Due to the ongoing growth, they are...

  • Project Lead

    4 days ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects. Due to the ongoing growth, they are...

  • Project Lead

    4 days ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects. Due to the ongoing growth, they are...

  • Project Lead

    4 days ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects. Due to the ongoing growth, they are...

  • Project Lead

    4 days ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects. Due to the ongoing growth, they are...

  • Project Lead

    4 days ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects. Due to the ongoing growth, they are...

  • Project Lead

    4 days ago

    Macclesfield, United Kingdom Albion Rye Associates Full time

    My client is a fast-growing Contract Research Organisation (CRO) located near Macclesfield. They provide specialist bioanalytical services to support discovery and regulatory drug development programs. They provide services to support clients with small & large molecule, peptide, oligonucleotide and biomarker projects. Due to the ongoing growth, they are...

  • Operations Leader, Sterile

    7 days ago

    Macclesfield, United Kingdom AstraZeneca Full time

    **Job Title: Operations Leader, Sterile** **Location: Macclesfield** **Introduction to role**: Join us as an Operations Leader and play a pivotal role in leading a multi-disciplinary team. You will be accountable for the overall performance of all processes within the boundaries of your Process Execution Team (PET) control. This includes production,...

  • Associate Process Leader

    1 day ago

    Macclesfield, United Kingdom AstraZeneca Full time

    Associate Process Leader Location: Macclesfield, UK Competitive salary and benefits Introduction to role: Are you ready to take the next step in your career and develop your supervisory skills? Join us at AstraZeneca, where you can make a meaningful difference to patients’ lives. With science at its heart, our work is about transforming...

  • Project Administrator

    3 days ago

    Macclesfield, United Kingdom Barlow Wood Recruitment Full time

    **Project Administrator - Macclesfield** **Salary up to £25, 000pa +Bonus + Benefits** **Hybrid working** - Graduates welcome to apply_ Provide project teams with a single point of contact for the operational needs of a project. Coordinate fieldwork & analysis/data processing, interacting effectively with both internal and external resources. Manage the...

  • Project Administrator

    1 month ago

    Macclesfield, United Kingdom Contrast UK Ltd Full time

    The business is a global player within the Pharmaceutical Consultancy market, working on complex research studies that use varied external partners - and that’s where you come in. You will be supporting one of the senior leaders, helping to manage the relationships with the suppliers that play an integral part in the project processes. You will be given...

  • Analytical Chemistry Team Leader

    35 minutes ago

    Macclesfield, United Kingdom Sai Life Sciences Ltd Full time

    **Role **Analytical Chemistry Team Leader **Location **Alderley Park, Cheshire, England **Job Type **Permanent **Salary** £50,000 - £80,000 **Date posted **June 2023 **Start date **ASAP **The Company** Sai Life Sciences is a leading global Contract Research & Development and Manufacturing Organisation (CDMO) that provides integrated drug substance...