Associate Director, Small Molecule Analytical Development
Associate Director, Small Molecule Analytical Development
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Job Description
Position Summary:
ultrainnovative Tackle rare and dynamic challenges
We are seeking a highly motivated and experienced individual to lead analytical development for Ultragenyxs small molecule products. This position will report to the Director of Analytical Development in Technical Development and represent analytical development function in CMC development teams to enable successful regulatory filings of new products.
Work Model:
Flex: This role will typically require onsite work 23 days each week or more depending on business needs. In many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Lead analytical method development / transfer of small molecule drug substance key starting materials intermediates drug product and oral solid dosage form.
- Be an integral part of crossfunctional and crossdiscipline CMC teams for small molecule products to deliver project milestones on time and within budget.
- Author relevant sections in regulatory filings and address agency questions
- Provide analytical support for process optimization scaleup tech transfer and process characterization activities for both drug substance and drug product.
- Collaborate with Quality Control to set product release and stability/shelflife specifications
- Participate in selection and evaluation of CROs and CDMOs.
- Support Manufacturing and Quality in deviation investigations and product life cycle management.
- Support Translational Research and Business Development as a technical consultant.
- Follow all safety and compliance regulations and company policies at work.
Requirements:
- A degree in Chemistry or a related discipline. PhD with minimum 5 years relevant working experience or MS with minimum 12 years or BS with minimum 15 years.
- Must have handson experience in analytical method development for small molecules drug substances and drug products. Method qualification and validation experience is a plus.
- Must have extensive knowledge and handson experience with analytical techniques including HPLC LCMS GC GCMS UV/Vis and Dissolution.
- Experience of impurity identification in both Drug Substance and Drug Product is a plus.
- Knowledgeable in ICPMS/IPCOES DSC DVS and XRPD techniques are a plus.
- Working knowledge of quality and regulatory requirements of small molecule products including cGMP/GLP FDA USP Ph. Eur and ICH guidelines
- Experience working with CDMO/CRO to lead analytical method development method transfer method qualification/validation is preferred.
- Excellent problemsolving skills and verbal and written communication skills.
- Experience in both early and late stage CMC development is desired. #LIHybrid
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Required Experience:
Director
Employment Type
Full Time
