Associate Director Device Development & Manufacturing

Redwood City, California

30+ days ago

Job Description

Associate Director Device Development & Manufacturing

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.

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.

Your Role:

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.

The Allakos Values are: Selfless, Drive, Clarity, Thoughtful, Fun, and Leadership.

The salary is competitive and commensurate with experience and qualifications.

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.

Numbers & Facts

Location	Redwood City, California
Website	https://www.allakos.com/careers/open-positions/

Skills

Analysis Skillsunmatched
Antibodiesunmatched
Business Skillsunmatched
CMOSunmatched
Calendar Managementunmatched
Communication Skillsunmatched
Compiler Technologyunmatched
Cross-Functionalunmatched
Design Documentunmatched
Detail Orientedunmatched
Document Managementunmatched
Drug Delivery Devicesunmatched
Drug Developmentunmatched
FDA (Food and Drug Administration)unmatched
Failure Mode and Effects Analysis (FMEA)unmatched
Functional Programming Languagesunmatched
Hazard Analysisunmatched
ICH Regulationsunmatched
ISO (International Organization for Standardization)unmatched
Industry Standardsunmatched
Inflammatory Diseasesunmatched
Leadershipunmatched
Management Consultingunmatched
Manufacturingunmatched
Manufacturing Assemblyunmatched
Meeting Minutesunmatched
Operational Communicationsunmatched
Operational Strategyunmatched
Problem Solving Skillsunmatched
Process Validationunmatched
Product Designunmatched
Product Developmentunmatched
Product Programsunmatched
Quality Assurance Methodologyunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Risk Managementunmatched
Strategic Planningunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Technical Operationsunmatched
Technical Strategyunmatched
Time Managementunmatched
Validation Testingunmatched

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Associate Director Device Development & Manufacturing

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