Position Summary

The Associate Manager, CMC Project Management will assist in the maintenance of operational systems that enable GXP activities in the development and commercial environment, including project plans with regards to resources, budgets, plans and timelines. This individual will be expected to collaborate with Regulatory, Quality Assurance, Clinical Operations and Clinical Program Management departments across Odonate to ensure operational activities in line with corporate goals.

Essential Duties and Responsibilities

  • Assist in monitoring project plans with regards to resources, budgets and timelines across projects within Technical Operations department
  • Communicate with Technical Operations team and consultants to address issues and to ensure that functional plans are harmonized, risks identified and critical decisions are made in a timely manner
  • Assist with tracking and communicate project progress to direct supervisor
  • Day-to-day participation in internal Technical Operations meetings and external vendor meetings, including keeping records of meeting minutes, tracking action items and following up with Technical Operations team, consultants and external vendors to ensure agreed upon project milestones are met
  • Assist with tracking the requisition, submission, review and approval process of Technical Operations contracts with the Legal and Accounting
  • Assist with documentation storage and organization for Technical Operations team, including use of company shared drives and web-based document sharing sites

Qualifications

  • Bachelor’s Degree in Chemistry or related science required
  • Minimum 3 years of experience in a GMP bio-pharmaceutical industry required
  • General understanding of the pharmaceutical development requirements for small molecule based drugs required
  • Must have working knowledge of CGMPs (CFR/ICH/EU) and applicable international regulations and guidelines
  • Previous experience with analytical and process development, manufacturing and supply chain
  • Excellent organizational skills with the ability to manage staff, projects, resources, timelines and budgets
  • Strong project management skills with an emphasis on organization, creative thinking and problem solving
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
  • Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
  • Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
  • Advanced proficiency in Microsoft Office (Word, Power Point, Excel and Project)

Apply for this Job

* Required
  
Attach Dropbox Google Drive Paste
  
Attach Dropbox Google Drive Paste
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 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 www.dol.gov/ofccp.

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 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.