Manager, Manufacturing Management Biologics

vor 3 Wochen

Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit

**Why Join Us?**
- Be a hero for our rare disease patients_

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team_. _

**Position Summary**:
**_ ultra_**_focused - Work together to fearlessly uncover new possibilities_

As Manager, Manufacturing Management Biologics & mRNA, you will play a key role in supporting the late-stage development, launch, and commercialization efforts of our Biologics and mRNA product portfolio. Reporting directly to the Director, Biologics and mRNA Manufacturing Management, you will leverage your expertise to drive strategic initiatives, foster CMO relationships, and ensure effective coordination across various cross-functional teams. This position presents an opportunity to contribute significantly to the advancement of innovative therapies for rare diseases.

**Work Model**:
Flex: This role will typically require onsite work 2-3 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**:

- Collaborate with cross-functional teams to support key projects within the Biologics and mRNA manufacturing domain, ensuring alignment with strategic objectives.
- Support the Biologics External manufacturing team with tactical and transactional work with our CMO partners on our commercial and clinical-stage products
- Identification, management, and mitigation of risks at the program and CMO level in order to increase program success
- Management of change control records to enable production activities
- Assessment of deviation events occurring during manufacturing
- Representing the Manufacturing Management organization in cross-functional CMC teams
- Management and follow up of contractual and financial records such as SOWs, POs, and Invoices

**Requirements**:

- Bachelor's degree or advanced degree in Science (Chemical Sciences, Pharmaceutical Sciences, Biological Sciences), Engineering (Biopharmaceutical, Chemical, Biochemical) or related field.
- Minimum of 5-10 years in Operations, MSAT, or Quality role supporting GMP drug product manufacturing of biopharmaceuticals
- Exposure to managing aspects of CMC projects is desirable.
- Familiarity with cGMPs, pharmaceutical industry procedures, and regulatory requirements.
- Experience in Drug Substance in addition to Drug Product is a plus
- Experience with Veeva Quality Management System is a plus
- Travel: approximate 5-15%
- Demonstrated ability to collaborate effectively and communicate with cross-functional teams. **#LI-CK1** **#LI-Hybrid**

**_Full Time employees across the globe enjoy a range of benefits, including, but not limited to:_**
- **_Generous vacation time and public holidays observed by the company_**
- **_Volunteer days_**
- **_Long term incentive and Employee stock purchase plans or equivalent offerings_**
- **_Employee wellbeing benefits_**
- **_Fitness reimbursement_**
- **_Tuition sponsoring_**
- **_Professional development plans_**
- _Benefits vary by region and country_
- See our _CCPA Employee and Applicant Privacy Notice_._
- See our _Privacy Policy_._

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