*Vice President for Process Development

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Do you want to lead a large biologics drug substance process development organization with state of the art laboratories? Do you want to play a key role in developing AGC Biologics technology platform and service offerings? Do you want to play a key role in bringing new products to market?

Then join AGC Biologics as VP Process Development and become part of an international and modern organization that delivers biopharmaceutical development and manufacturing right and on time.

The position
The Vice President (VP) of Process Development (PD) will be responsible for overseeing the development and commercialization of biologic drug candidates. The VP will provide leadership to an organization responsible for Upstream Process Development (UPD), Downstream Process Development (DPD) and Analytical Development (AD). The area covers both Microbial and Mammalian Cell Culture, early and late stage development including process and technology development.

The VP of PD will be a member of the site senior Leadership Team (LT), responsible for providing leadership and decision making to the Copenhagen site. At LT level each member is head of a specific area, but all challenges are a collective problem and the members solve them together. Hence, it is important to be a team player and being able to create one voice as a team. Additionally, the VP of PD will be part of the Global Operational Team and collaborate extensively with the other PD sites.

Responsibilities

  • Provide leadership and strategic direction to the Process Development organization, an area of 100+ scientists and technicians organized in operational teams with 3 direct reports
  • Serve as an active member of the site Leadership Team responsible for development and setting of site strategy and goals
  • Mentor and develop directors and staff members within the organization
  • Oversee development operations working on projects ranging from early phase to commercial stage biologics
  • Champion the development and implementation of new technologies, methodologies and systems to drive innovation in biologics development
  • Develop strong relationships with AGC customers; support the creation of strategic plans with clients for the development of biologic drug candidates
  • Work closely with Business Development in support of recruiting new customers and partners
  • Drive development and implementation of new systems to improve project execution and data management
  • Support regulatory filings (INDs, BLAs, MAAs, etc.) and associated product related inspections from regulatory agencies (FDA, EMA, etc.)
  • Provide technical support to the cGMP manufacturing operation
  • Develop and manage department budgets
  • Ensure the department is positioned well for future growth

Qualifications
You have experience with biopharmaceutical drug substance development, technology evaluations, strategic planning and people management. You have a relevant academic background within pharmacy, biotechnology, chemical engineering or similar. You must have strong leadership skills and experience in several of the following areas:

  • Ph.D. in Science or Engineering or Master in Science
  • 15+ years of experience in biopharmaceutical development with a strong background in biologics product development
  • Experience developing, implementing and executing strategic plans and objectives for organizations and departments
  • Exceptional customer interface skills are required
  • Understanding of current industry trends and regulatory expectations associated with QbD and Process Validation
  • Experience supporting regulatory filings (e.g., INDs, BLAs, MAAs, etc.) and supporting product-related
    inspections for US and foreign regulatory agencies

We continuously evaluate incoming applications and conduct interviews accordingly. The job ad will close when we have found the right candidate.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Direktør", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 4.5.2022, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Direktør
  • København
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