Summary of the Position:

The Associate Director, Cell Therapy CMC Project Manager (PM) role is a member of the PMO - Business Planning and Operations team within the Cell Therapy Development and Operations (CTDO) function. The CMC PM supports the delivery of cell therapy CMC outputs from early research through to launch. The CMC PM plans CMC activities, managing resources and costs for product development and clinical manufacturing, and enables advancing platform and novel processes. We ask that you plan, escalate issues to ensure successful project delivery.

The CMC PM leads the CTDO functional drug project team that consists of team leaders that represent process development, analytical development, supply chain, quality, and manufacturing. The Associate Director drives and ensures project delivery within governance-endorsed timelines, scope, and cost. The role may also manage strategic programs, including process improvements and system implementations, but not limited too.

Responsibilities:

Lead the translation of drug and clinical development strategies into comprehensive CMC project plans that align with timelines, quality standards, budgets, resources, risk assessments, and AstraZeneca's strategic goals.

Organize and facilitate CMC project team meetings, develop structured agendas, track and lead actions to completion, and facilitate workshops to enhance team collaboration.

Manage project risks, engage the project team, and activate mitigation strategies to resolve challenges impeding project goals.

Collaborate with CMC team leaders, manufacturing sites, supply chain teams, and external partners address operational challenges and guide successful outcomes.

Lead and coordinate comprehensive project updates, ensuring across project teams, senior leadership, and critical team members.

Implement and guide essential CMC project management programs and process improvements to foster project effectiveness.

Be an expert resource for implementing advanced project management strategies.

Maintain dynamic business processes, and technologies to manage a diverse project portfolio.

Introduce new and improved methodologies for project planning and execution to foster innovation across teams.

Partner with CMC Project Leaders, Global Program Managers, and Finance Partners to manage program budgets and guide strategic resourcing decisions.

Collaborate with leads to establish informed project resource forecasting and allocation decisions.

Education and Experience Requirements:

10+ years with a BS, 5+ years with an MS, and 3+ years with a PhD in relevant experience.
Bachelor's, Master's, or PhD in relevant technical fields such as Biochemistry, Cell Biology, Molecular Biology, Immunology, or Chemical Engineering, or equivalent industry experience.

Broad and comprehensive knowledge in CMC project management, specifically in autologous or allogeneic cell therapy process development, regulatory and quality compliance, and analytical development department.

Required Skills:

Management experience overseeing CMC programs, with a successful track record in project delivery, risk management, and overcoming operational challenges.

Project management capabilities, proficient in using Smartsheet, MS Project, Program budget tracking, and complementary management tools.

A collaborative team player who encourages open and facilitates mutual understanding among diverse partner groups.

Advanced degree or relevant field experience.

Professional Project Management certification preferred.

Build execution timelines and plans based on business strategy.

Combined experience in Project Management within CMC or Process Development.

The annual base salary for this position ranges from $134,866 to $202,299.60. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Our Benefits:

Benefits offered include:

A qualified retirement program [401(k) plan]
Paid vacation, holidays, and paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

#celltherapy #LI-Onsite

Date Posted
21-Mar-2025

Closing Date
17-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca

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Associate Director, Cell Therapy CMC Project Manager