Director/Senior Director, Lirentelimab CMC Team Leader
Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases.
Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
The CMC Team Leader reports to the SVP, Technical Operations and is accountable for the AK002 (lirentelimab) CMC project activities from early stage clinical development through to commercialization, including BLA activities. This person will be a key member to the Lifecycle Product team. This role will require a candidate who is comfortable working collaboratively in a cross-functional team with technical, business, quality, regulatory representatives who also enjoys providing hands-on program leadership that will support successful execution of these critical activities.
- Lead a cross-functional CMC team with functional members/sub-team leaders from Technical Operations, Regulatory and Quality, including cell culture, purification, formulations, drug product, bioanalytics, analytical development, Quality Control, device development, Quality Assurance, CMC Regulatory, Regulatory Operations, CMC Program Management, and Supply Chain / Logistics.
- Creates a strategic and integrated CMC development plan based on global project objectives ensuring alignment with base case plans and exploring opportunities for acceleration.
- Represent the CMC team and functions as core member to Executives, contributes to overall project strategy and executes the appropriate actions within CMC to achieve project goals, including development of the Quality Target Product Profile (QTPP).
- Acts as overall product/process expert for the project and provides technical and scientific expertise on major project topics, drives and leads technical and scientific discussion and alignment within the CMC team and in cross-functional governance and manufacturing advisory board meetings.
- Responsible for quality of CMC contributions to clinical and process validation work packages (DS/DP/Analytics), and CMC elements for regulatory submissions and consultations.
- Drive the evaluation of CMC risks and appropriately escalate to Senior Management and proactively provides mitigation plans.
- Partners with the CMC Lifecycle Management Team to provide technical support and expertise on the implementation and execution of Health Authority post-approval commitments.
- Alert decision makers and stakeholders to risks that can impact critical program timelines. In case of scientific/technical issues, coordinate corrective measures across functions in cooperation with all relevant site and department heads as needed.
- Responsible for implementation of CMC deliverables within budget considering external and internal costs. He/she leads and oversees planning of CMC project budget including communication and alignment with lirentelimab project team and senior management.
Qualifications and Expertise:
- Bachelor’s or master’s degree in biotechnology, pharmaceutical engineering or natural sciences or related discipline with a minimum of 14 years of relevant industry experience or PhD with minimum of 10 years of relevant industry experience.
- Strong Biologics CMC expertise with proven experience in at least 2 scientific disciplines e.g. analytics, process dev, manufacturing, CMC regulatory, etc
- Experience and understanding of the current Pharmaceutical environment including the economic and regulatory challenges. Experience in BLA submission is a must.
- Strong leadership and team building capabilities, and able to effectively coordinate several multiple activities and stakeholders. Excellent communication, stakeholder management and networking skills.
- Ability to interact effectively with Senior Management Executives and external bodies (e.g., auditors, health authorities, etc.). Strong influencing and negotiation skills to build solutions and partnerships
- Take responsibility for decisions and be accountable for results
- Ability to work effectively in a fast paced, highly matrixed organization.
The salary is competitive and commensurate with experience and qualifications.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.