Director - Cmc Leader In Large Molecule Biologics

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Director - CMC Leader in Large Molecule Biologics. The position is to be located within the US (Malvern, PA (highly preferred) or Spring House, PA); Belgium (Beerse); Ireland (Cork); Switzerland (Schaffhausen); or the Netherlands (Leiden). Relocation may be provided for the right candidate.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com .

At Janssen ( www.janssen.com ), we're creating a future where disease is a thing of the past. We're working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Neuroscience, Oncology and Pulmonary Hypertension.

Within the CMC 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).

You will see opportunities for team or product development improvements across the TDS 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 Large Molecule CMC protein and Antibody Drug Conjugate development process, preferably including an understanding of early, late and LCM development.

• A Bachelor's degree in life science or related field with at least 10 years of experience in pharmaceutical, biotechnology or a related industry OR a Master's degree in life science or related field with at least 8 years of experience in pharmaceutical, biotechnology or a related industry OR a Ph.D. with at least 6 years experience in pharmaceutical, biotechnology or a related industry is required
• Large Molecule CMC experience is required.
• 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.
• Experience in developing antibody drug conjugates is highly preferred.
• Experience in setting development and regulatory strategies for products in development is required.
• Demonstrated capability to manage multiple projects is required.
• 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 is required
• Influencing ability without line authority is preferred.

What is in it for you?

• Contributing to our mission to continue to bring transformational new medicines to patients for a world without disease.
• Being part of a motivated and experienced global research team in an innovative and diverse working environment
• A competitive salary, health promotion and energy programs and other benefits for you and your family

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.