Senior Director Upstream Process Development
Senior Director Upstream Process Development
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Job Description
Position Summary:
ultrainnovative Tackle rare and dynamic challenges
This position seeks a highly motivated and experienced technical leader to lead the development of upstream process development for Ultragenyx pipeline products including proteins antibodies therapeutic messenger RNAs and AAVbased gene therapy products. This position reports to the VP Technical Development and will interact with all levels across the company organizations. He/she will be part of the Technology Development team Global CMC Development and will lead key program development activities internally as well as at external CDMOs. He/she will provide strategic direction technical expertise and tactical oversight for activities in upstream process development for latestage and commercial stage programs.
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 BLA enabling development of a latestage antibody asset via external manufacturing.
- Manage a complex technology transfer troubleshoot manufacturing deviations and author PAS to ensure global access for the antibody asset.
- Establish external and internal upstream process development strategies in alignment with Global CMC Development program teams and CMC subteams goals and priorities.
- Lead upstream process development including cell culture process development tech transfer and scale up process characterization and validation of biologics and enzymes.
- Lead the mammalian and microbial process development to support development nonGMP production and troubleshooting of GMP manufacturing.
- Lead external development at CDMOs manage communications contracts timelines and budget oversee tech transfer process improvement and investigation in support of GMP manufacturing and product supply.
- Collaborate effectively crossfunctionally and crosscompany with external partners downstream analytical manufacturing quality etc. to deliver project milestones on time and within budget.
- Build and manage upstream team to achieve consistently positive results including but not limited to recruiting mentoring and managing inhouse team.
- Author and review SOPs technical reports IRs and relevant sections of regulatory IND/BLA/MAA fillings and interacts with global regulatory agencies.
- Follow all safety and compliance regulations and company policies at work.
Requirements:
- PhD in Chemical Engineering Biochemistry or related field with minimum 10 years of relevant working experience or MS with minimum 12 years or BS with minimum 15 years with 5 years of leadership experience
- Must have handson experience in Upstream Process Development of biologics MSAT Manufacturing and/or Engineering in biotech/pharmaceutical industry
- Proven track record of accomplishments in the design development and validation of clinical and/or commercial stage biologics manufacturing processes with emphasis on upstream process development.
- Strong track record of successful IND/IMPD/BLA/MAA filing and familiarity with quality and regulatory requirements of large molecule products including ICH guidelines.
- Significant experience working in an outsourcing environment. GMP manufacturing experience is preferred.
- Strong interpersonal skills and the ability to lead the team managing inhouse USP team and effort.
- Must have excellent problemsolving skills with proven ability to work autonomously and manage effectively in a matrix environment.
- High attention to detail excellent organizational skills and the ability to work on multiple projects with tight deadlines.
- Must be willing to travel 10 of time. #LICS1#LIHybrid
The typical annual salary range for this fulltime position is listed below. This range reflects the characteristics of the job such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$251500 $310700 USD
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:
Exec
Employment Type
Full Time
