Distinguished Scientist, CMC Team Leader, Protein Conjugates

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

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Distinguished Scientist, CMC Team Leader, Protein Conjugates to be located in Malvern, PA or Spring House, PA,

Purpose:

Within the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle Management (LCM). You will be the CMC point of contact with the Compound Development Team(s) (CDT) and Value Stream Teams (VST).

You will be responsible for:

• 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.
• seeing 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.
• demonstrating 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.
• focusing on development projects which may span multiple Therapeutic Areas (TAs) and/or Innovative Medicine Supply Chain (IMSC) 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 Bioconjugates (include Antibody Drug Conjugates and radio-ligand therapy) development process, preferably including an understanding of early, late and LCM development.

Qualifications / Requirements:

Education:

• a minimum of a Bachelor’s degree in life science or related field is required
• a Master's degree or Ph.D in life science or related field is highly preferred

Required:

• a minimum of 10 years relevant experience is required. A combination of industry & post doc experience is acceptable
• Large Molecule CMC experience is required.
• Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills are required
• Excellent interpersonal skills with the ability to adapt effectively to a constantly evolving organization issues, structures and dynamics is required
• 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

Preferred:

• Experience in developing antibody drug conjugates or radio-ligand therapy is highly preferred
• Influencing ability without line authority is preferred<