Position Summary

The Senior Director, Manufacturing will be fully accountable for Odonate’s drug substance and drug product contract manufacturing. This position will lead tech transfers, process development and manufacturing operations to support the Phase 3 study through commercialization. The Senior Director, Manufacturing will serve as drug substance and drug product subject matter expert and author drug substance and drug product sections for regulatory documents.

Essential Duties and Responsibilities

  • Manage Odonate’s drug substance and drug product Contract Manufacturing Organizations (CMOs), including PIP responsibilities, to ensure uninterrupted drug supply manufactured within GMP compliance, CMC regulatory filings and Odonate standards
  • Manage manufacturing operations, including tech transfer, scheduling, logistics, batch record review, change controls, QA investigations, review of validation protocols and reports, development of specifications
  • Serve as drug substance and drug product subject matter expert on teams
  • Oversee late-stage development activities, including DOE and PAR studies, registration and validation manufacturing
  • Author drug product sections for regulatory documents, including IND amendments, NDA and MAA
  • Generate budgets, technology packages and RFPs
  • Negotiate MSAs, WOs and SOWs

Qualifications

  • PhD in Organic Chemistry required
  • Minimum 15 years of progressive experience in a manufacturing or supply chain organization within the pharmaceutical industry required
  • Experience in launching and commercializing new products, including both NDA and ex-EU marketing applications a plus
  • Deep knowledge of US and European Good Manufacturing Practices (cGMP)
  • Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
  • Ability to organize and assimilate data and information, to prepare contingency plans and future strategies
  • Be proactive in initiating continuous improvement projects
  • Excellent strategic thinking skills with demonstrated ability to successfully create and implement both short-term and long-term plans to support the department and business needs
  • Ability to effectively engage and influence internal and external leaders, solicit information, persuade others and shape outcomes
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
  • Must be willing and able to travel domestically and/or internationally up to 50%

Apply for this Job

* Required
  
  
When autocomplete results are available use up and down arrows to review
+ Add Another Education


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

Individuals seeking employment at Odonate Therapeutics 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 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I 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:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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 www.dol.gov/ofccp.

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.