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Johnson & Johnson zoekt een

CMC Leader, Scientific Director

Leiden, Netherlands; Malvern, United States

Description

Johnson & Johnson is currently seeking a CMC Leader, Scientific Director within the Portfolio Management group located in either Malvern, PA or Leiden, Netherlands.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Within the Portfolio Management group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle Management (LCM). This includes, but is not limited to, the creation and implementation of the development strategy, the adherence to the CMC 12 Stage process, approval by governance bodies, the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and timelines, and the delivery of clinical and launch drug supplies in accordance with development plans. You will be the CMC point of contact with the Compound Development Team(s) (CDT) and Value Stream Teams (VST).

Description:

·         You will see opportunities for team or product development improvements across the DPDS organization. They may also support or lead teams in implementing initiatives to deliver organizational or process improvements.

·         You will demonstrate behaviors consistent with the current Leadership Imperatives and will be mentoring and coaching CMC Team Members to improve their skills and contributions to the organization in collaboration with line management.

·         Your main focus is on development projects which may span multiple Therapeutic Areas (TAs) and/or Janssen Supply Chain (JSC) and stages of development.

·         Working in a multi-disciplinary, complex and innovative environment, with evidence of delivering results in this setting, including: In-depth experience and technical knowledge of the Biologics CMC development process, preferably including an understanding of early, late and lifecycle management development.

Qualifications

  • Bachelors degree with 14 years of experience; OR a Masters degree with 12 years; OR a Ph.D. with 10 years of proven experience in pharmaceutical, biotechnology or a related industry
  • Biologics CMC experience is required such as in the areas of monoclonal antibodies, vaccines, antibody drug conjugates, mRNA, cell therapy or gene therapy.
  • Experience in setting development and regulatory strategies for products in development is required
  • Cell & Gene Therapy CMC experience is preferred
  • Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills
  • Excellent interpersonal skills with the ability to adapt effectively to a constantly evolving organization issues, structures and dynamics
  • Demonstrated capability to manage multiple projects
  • Ability to make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment to these decisions
  • Influencing ability without line authority
  • This role can be based in Malvern, PA or Leiden Netherlands and may require up to 10% travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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Blijf op de hoogte van de laatste farma vacatures