Allakos Inc
Associate Director Device Development & Manufacturing
Allakos Inc, Redwood City, California, United States, 94061
Associate Director Device Development & Manufacturing Join to apply for the
Associate Director Device Development & Manufacturing
role at
Allakos Inc Associate Director Device Development & Manufacturing 3 weeks ago Be among the first 25 applicants Join to apply for the
Associate Director Device Development & Manufacturing
role at
Allakos Inc 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.
The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.
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.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionOther Referrals increase your chances of interviewing at Allakos Inc by 2x Sign in to set job alerts for “Associate Director of Development” roles.Vice President, Manufacturing Operations Brisbane, CA $319,000.00-$355,000.00 4 days ago Sunnyvale, CA $160,000.00-$200,000.00 1 month ago Mountain View, CA $221,298.00-$260,350.00 1 week ago Hayward, CA $271,000.00-$326,000.00 1 week ago South San Francisco, CA $210,000.00-$230,000.00 1 month ago San Jose, CA $146,000.00-$255,000.00 13 hours ago Director, Global External Manufacturing, OSDDirector of Manufacturing, Advanced Process Technologies Sunnyvale, CA $179,800.00-$317,400.00 4 hours ago Director, Drug Product Development & Manufacturing San Francisco, CA $160,000.00-$175,000.00 2 weeks ago Fremont, CA $112,500.00-$150,000.00 1 week ago Redwood City, CA $186,500.00-$219,400.00 4 days ago San Mateo, CA $217,000.00-$301,000.00 2 weeks ago Foster City, CA $180,000.00-$200,000.00 1 week ago San Francisco, CA $178,900.00-$310,300.00 1 hour ago Executive Director of MFG Sciences and TechnologySenior Director of Robotics Product Operations Sunnyvale, CA $309,000.00-$358,000.00 1 week ago San Jose, CA $163,200.00-$204,000.00 1 week ago San Jose, CA $191,900.00-$255,800.00 6 days ago South San Francisco, CA $205,000.00-$229,000.00 2 weeks ago Director/Senior Director Project Management San Leandro, CA $84,635.00-$111,716.00 5 days ago Director of Operations JN -072025-163631Engineering Director ( Electronics Manufacturing ) Santa Clara, CA $105,000.00-$130,000.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Associate Director Device Development & Manufacturing
role at
Allakos Inc Associate Director Device Development & Manufacturing 3 weeks ago Be among the first 25 applicants Join to apply for the
Associate Director Device Development & Manufacturing
role at
Allakos Inc 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.
The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.
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.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionOther Referrals increase your chances of interviewing at Allakos Inc by 2x Sign in to set job alerts for “Associate Director of Development” roles.Vice President, Manufacturing Operations Brisbane, CA $319,000.00-$355,000.00 4 days ago Sunnyvale, CA $160,000.00-$200,000.00 1 month ago Mountain View, CA $221,298.00-$260,350.00 1 week ago Hayward, CA $271,000.00-$326,000.00 1 week ago South San Francisco, CA $210,000.00-$230,000.00 1 month ago San Jose, CA $146,000.00-$255,000.00 13 hours ago Director, Global External Manufacturing, OSDDirector of Manufacturing, Advanced Process Technologies Sunnyvale, CA $179,800.00-$317,400.00 4 hours ago Director, Drug Product Development & Manufacturing San Francisco, CA $160,000.00-$175,000.00 2 weeks ago Fremont, CA $112,500.00-$150,000.00 1 week ago Redwood City, CA $186,500.00-$219,400.00 4 days ago San Mateo, CA $217,000.00-$301,000.00 2 weeks ago Foster City, CA $180,000.00-$200,000.00 1 week ago San Francisco, CA $178,900.00-$310,300.00 1 hour ago Executive Director of MFG Sciences and TechnologySenior Director of Robotics Product Operations Sunnyvale, CA $309,000.00-$358,000.00 1 week ago San Jose, CA $163,200.00-$204,000.00 1 week ago San Jose, CA $191,900.00-$255,800.00 6 days ago South San Francisco, CA $205,000.00-$229,000.00 2 weeks ago Director/Senior Director Project Management San Leandro, CA $84,635.00-$111,716.00 5 days ago Director of Operations JN -072025-163631Engineering Director ( Electronics Manufacturing ) Santa Clara, CA $105,000.00-$130,000.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr