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.
Position Summary:
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.  
Your Role:
  • 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.

Apply for this Job

* Required

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Allakos are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.