Vice President Commercial Manufacturing
Join a Fast Growing Biotech Company, entering a new phase
Ascendis Pharma A/S, a visionary and ambitious company, offers you a once-in-a-lifetime opportunity to become a major participant in the further establishment of the structure and function of Commercial Manufacturing.
Ascendis Pharma is focused on building a leading rare disease company providing meaningful improvements in patients’ lives by developing best-in-class therapeutics addressing unmet medical needs by applying Ascendis’ TransCon technology platform.
As Vice President Commercial Manufacturing at Ascendis Pharma you will have responsibility over Commercial Manufacturing/Technical Operations. You will directly contribute to establishing and maintaining commercial manufacturing for Ascendis Pharma’s products through building a structured, yet agile organization that will support the company’s objective to gradually move towards commercial operations and become a fully integrated pharma company. In cooperation with CMC Development, you will secure a seamless technical transfer from development to product supply and make sure all technical operations within the supply chain will and can fulfill Ascendis’ requirements for a sustainable and robust supply to all markets from pre-launch activities.
All commercial manufacturing activities are outsourced to various CMOs. In this role, you will collaborate closely with external stakeholders (CMOs) as well as internal stakeholders.
With direct report to SVP, Product Supply (PS)
Your main tasks are:
- Overall responsibility for CMOs and all technical operations
- Overall responsibility for providing leadership and oversight for the ComMan area in Ascendis
- Provide input to the strategic development of PS as part of the company’s PS Management Team
- Support Proccess Verification/Qualification (PPQ) including parameter studies
- Support filing, launch and preparation for regulatory inspections
- All aspects of commercial production including continued process verification
- QC Operation oversight at CMOs
- Establish production metrics at CMOs
- Responsibility for tech transfers of manufacturing processes and analytical methods in cooperation with CMC after/during PPQ (process verification) to ensure smooth and efficient transfers
- Responsibility for scale-up and site transfer for manufacuturing processes and analytical methods post submmission and launch
- Build best in class operations teams and leaders, and work seamlessly with the rest of the organization
- Manage, lead, and develop the ComMan organization
- Further develop and enhance relationships with CMOs, ensuring an optimal manufacturing foot print, delivering best quality and timely supply to market in order to meet the complex needs of Ascendis, while providing cost optimization and competitive CoGS and services.
- Develop manufacturing strategies in alignment with commercial and partnering strategies for each product
You are an experienced commercial manufacturing/technical operations leader, with late stage biotech experience, preferably having participated in building commercial pharmaceutical operations in a very international and outsourced context. You have practical experience in supporting biotech and commercial stage products from late stage development through launch, by leading a best in class technical operation, in addition to managing the current and future CMO network from a technical/operations point of view. Preferably, you will have experience from working within the majority of the following areas: chemical starting materials, peptides, Drug Substance (DS – biologics, including proteins conjugated to polymers and peptides), Drug Products (aseptic production), QC, and Devices.
You have a Master’s Degree in Chemistry, Engineering, Pharmacy or a related discipline. Having an MBA is a plus. You are proficient in English at a professional level, both written and spoken. You master MS Office and experience with MS Projects or other project tools is an advantage.
You are a person with a high level of motivation who enjoys being challenged and working in collaborative environments. Strong interpersonal skills are necessary as your job is to establish good cooperation with CMOs, stakeholders and employees. Finally, you should possess an ability to think and manage strategically as well as operationally, and have a high energy level, focus and passion.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international NASDAQ listed company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy, and you will work with highly skilled and experienced colleagues to advance the company’s exciting product pipeline
Travelling: 30-40 days per year.
Domicile: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup.
For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25. All applications must be in English and are treated confidentially.