This is what you will do:
The Associate Director, is a cross-functional leader with excellent people management skills that is accountable for Alexion's small molecule and/or biologics external clinical drug substance / drug product/ external operations. This responsibility includes leading cross-functional groups within the Alexion network and across various contract manufacturing organizations, in addition to collaborative partnerships and newly integrated organizations, to drive manufacturing and program timelines. Strong communication skills, the ability to influence key stakeholders, and effective results-oriented negotiation practices, are critical to managing Alexion's internal and external relationships effectively. Success is measured by the ability to effectively plan and execute manufacturing operations internally and with external vendors. Additional success metrics include establishing and delivering clinical supply requirements, meeting financial targets, and guiding large projects both internally and externally that impact the organization globally.You will be responsible for:
You will need to have:
- Lead cross-functional teams of both internal and external stakeholders to ensure on time delivery and uninterrupted supply of clinical small molecule and/or biologics drug substance and drug products.
- In coordination with PDCS leadership, Oversee manufacture of Drug Substance and Drug Product for small molecule and/or biologics programs.
- Guide and Collaborate with internal/external technical groups to ensure on-time success of New Product Introduction and Technology Transfer activities, including handling and solving complex problems that may result in significant delays or inhibit program success.
- Work effectively with Development and Commercial Manufacturing to transition products to/from Clinical Manufacturing; implement solutions and best practices.
- Working together with the supply planner, develop and optimize supply models and define manufacturing schedules based on overall program knowledge and capabilities, including but not limited to technology-specific limitations, expiration dating, manufacturing timelines, development activities, and regulatory requirements.
- Facilitate the vendor identification and selection process for novel technologies, complex drug substance or drug product manufacturing processes, and/or those programs that are fast-tracked and high profile within the organization.
- Negotiate favorable master supply agreements, project plans, and statement of work documents with external partners based on agreed upon priorities from key stakeholders within the organization.
- Recommend short-term and long-term strategic clinical manufacturing plans to enable Clinical Trial execution at all phases of development.
- Develop and manage DS and DP program budgets, including those for external partnerships established by Business Development.
- Assist in developing strategic plans for process improvements and support implementation of projects within established budgets and timelines, including tech transfer and scale-up.
- Partner with the Quality Assurance group to manage on time review and release of batches, resolve deviations, and implement CAPA's
- Communicate operational status regularly to senior leadership
- Establish and track KPI metrics to evaluate CMO performance and Clinical waste
- Contributor to regular business review and joint steering committee meetings, joint project team meetings.
- The position requires approximately up to 10% travel.
We would prefer for you to have:
- BS in engineering/science or equivalent experience
- More than 8 years of experience in a cGMP small molecule/API manufacturing environment in drug substance, drug product and/or biologics
- Experience managing and building CMO relationships and/or technical oversight of manufacturing.
- Ability to influence decision making bodies both internally and externally to the organization.
- Forward-thinking and strategic approach to managing projects with the ability to assess the impact of cross-functional issues and to develop a supply or mitigation plan with appropriate level of stakeholder buy-in.
- Experience leading cross-functional teams, e.g. CMC Teams or others, within a manufacturing environment.
- Past history providing leadership to programs with a high degree of ambiguity, that are unchartered territory for the organization, and/or where limited to no manufacturing expertise or otherwise exists within the organization.
- Knowledge of cGMP and other regulatory requirements.
- Ability to drive accountability and effective at influencing decision makers both internally and with Alexion's external partners.
- Strong project management, presentation, communication, and negotiation skills.
- Demonstrate proactive approach to identifying and mitigating supply risks.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- Advanced degree a plus
- Experience working outside of Clinical Manufacturing, such as Development, Commercial Manufacturing, Business Development, Marketing, or Alliance Management.
- Experience with device development and manufacturing, combination products, biologics manufacturing, cell and gene therapies, and/or other novel technologies, is strongly desired.