Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history
This role provides CMC and Quality project management support for the Research and Development Portfolio of programs, partnering closely with the VP CMC/Tech Ops and the VP Quality. The position will support management, organization, collaboration and transparency of CMC and Quality team activities.
The role will ensure the CMC team meets key landmarks, goals and timelines as defined in the program strategy by developing and tracking timelines (in collaboration with CMOs and vendors), integrating the CMC timelines into the overall program timelines, documenting meeting minutes, actions and decisions, ensuring timely completion of activities/CAPAs, proactive management of the risk register, and other organizational and operational activities as needed.
In addition, the role will focus on supporting and ensuring that this cross-functional team is a strong team - excelling in planning, execution and collaboration.
The position reports to the Director of the Development Portfolio and Program Management.
The CMC Project Manager is responsible for all CMC and Quality PM activities across the Research and Development portfolio to ensure Alector’s R&D program goals are met.
Essential responsibilities include:
- Track, coordinate and communicate timelines across external Vendors and internal collaborators, including CMC and GMP Quality Assurance and Quality Control (QA/QC), to ensure an efficient process from bulk manufacture through product release and shipment.
- Partner with the VP CMC/Tech Ops, VP Quality and R&D PMs to ensure integration of CMC and QA/QC-related components and timelines into the overall R&D program timelines.
- Collaborate with Subject Matter Experts and Functional Area Representatives within CMC and QA/QC to ensure CMC timelines are updated and easily accessible for transparency in the organization.
- Support Vendor interactions, including integration of Vendor timelines into Alector internal timelines, tracking action items and decisions, and risk register management to ensure successful adherence to overall program timelines.
- Serve as a key resource for internal collaborators including CMC, QA/QC, CMC Regulatory, Program Team Leaders and Dev. PMs, and business functions such as Finance, for providing information on timelines, and communicating resource and budget needs to ensure overall program goals are met.
- Provide support for Joint Committee meetings with Development Partners in close collaboration with Alliance management.
- Identify and implement phase-appropriate tools and processes to improve efficiency in communication, collaboration, and optimization of planning and execution, both within Alector and with Alliance partners and Vendors.
- Support the CMC sub-team to ensure adherence to key achievements and timelines as defined in the program strategy, including management of key documentation such as meeting minutes, action items, decisions, risk log mitigations, and critical path activities.
- Promote effective decision-making and CMC sub-team behavior in alignment with team charters
- To proactively identify risks and critical path activities in the portfolio that could impact Alector’s key goals and achievements and to advance as needed.
Requirements
- Strong scientific background, minimum of a bachelor’s degree in the Sciences (advanced degree preferred; PMP Certification is a plus).
- 10-15+ years biopharma industry experience, including experience with biologics and virtual manufacturing, with a minimum of 5-8 years of experience in CMC project management; experience working in Process Sciences and with filing BLAs is preferred.
- Knowledge of the cross-functional CMC & Quality activities required to take a research program from development to commercial launch.
- Working knowledge of GLP, GMP and commercial material requirements.
- Thorough understanding of QA/QC and CMC activities and their integration into overall program plans and timelines.
- Proven success in ensuring collaboration and alignment cross-functionally.
- Excellent communication, decision-making and analytical skills.
- Ability to operate independently within a matrix organization
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At Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together.
Among the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us!
We believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
