Associate Director Device Development & Manufacturing
Associate Director Device Development & ManufacturingAllakos 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.
Position Summary:As a member of the Allakos team you will have the opportunity to form and lead our device/combination product program. You will be a strategic player within Technical Operations, by serving as a team leader for device development and device assembly/manufacturing. This is a leadership role to derive and execute a comprehensive drug/device combination product development and manufacturing development program at Allakos. This is an influential role in the organization that will interact extensively with Program Team members and Allakos leadership to deliver results. To be successful in this role, the ideal candidate must have parenteral drug delivery device development expertise including autoinjector development and design transfer experience, regulatory and quality awareness, strategic thinking, strong business acumen, excellent leadership and communication skills.
- Lead cross-functional team supporting the development and operationalization of Allakos drug delivery device programs. With responsibility for design controls, relevant CMC source documents necessary for regulatory filings or health authority interactions.
- Oversee product development, design transfer to manufacturing at CMOs, device testing, and project delivery.
- Lead drug/device combination product development through registration, tech transfer, process validation, and launch. Oversee development of design control documents, d-FMEA, hazard analysis, test methods, and validation studies.
- This role will represent the department by defining and communicating strategic operational direction, serving as a visible program champion and a focal point for critical program information, compiling the technical development plan, and recognizing and solving critical issues with the CMC Team and the department.
- This leader is accountable to deliver regulatory documents for global submissions.
- Effectively manage device development team meetings including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items.
- Manage and drive the various parts of the timeline and escalate issues as required.
- Develop critical path analyses to identify potential ways to accelerate timelines and mitigate risks.
- Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.
Qualifications and Expertise:
- Experience leading device development programs and cross functional development.
- Advanced knowledge of FDA, EMA and ICH, ISO regulations, and industry standards for drug/device combination products.
- Demonstrated technical proficiency, independent thought, and ability to effectively collaborate with others.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to communicate with leadership for greater outcomes.
- Strong team player that is solution oriented.
- Attention to detail and the ability to work as a leader, individually, within a multi-disciplinary team in a matrix environment, as well as with external partners.