CMC Leader, Scientific Director

Johnson & Johnson

4.2

(92)

Multiple Locations

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2406194490W

    Position summary

    e 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 https://www.careers.jnj.com.

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.