Johnson & Johnson

Biotherapeutic Drug Product & Clinical Trial Development Fellowship

Johnson & Johnson
Locations: Malvern & Spring House, PA
Recruiting: 1 Position for a 2-Year Fellowship

The Biotherapeutic Drug Product & Clinical Trial Development fellowship program provides the fellow with an opportunity to work on new modalities and technologies within the Drug Product Development & Delivery function of Johnson & Johnson. The fellow will be integrated into a team of scientists and engineers to engage in the development of new biologic and combination drug products using hands-on, laboratory-based techniques. The fellow will also work alongside a Trial Delivery Leader to plan and execute clinical trials. We are recruiting one fellow for this program to begin in 2027. 

This fellowship offers a parallel two-fold experience in which the fellow will have ongoing responsibilities in both of the following functions:

Biotherapeutic Drug Product Development (~75% of experience)

• Plan and lead an innovative research project that meaningfully contributes to scientific understanding and business needs
• Design and execute laboratory-based studies that support drug development activities and regulatory filings, such as:
  • Formulation and excipient selection
  • Manufacturing process development
  • Ancillary compatibility and in-use stability
  • Delivery feasibility and dose accuracy
• Author technical reports, maintain electronic laboratory notebooks, and communicate project findings
• Leverage clinical and pharmacy expertise to optimize drug product preparation and administration approaches and instructions, identify patient risks, and address unique challenges in biologic drug delivery
• Conduct literature searches and present updates on current clinical practices to scientific colleagues to encourage a patient and provider-centric approach to the drug development process

Clinical Trial Development (~25% of experience)

• Support the development of clinical trials, with opportunity to gain exposure to various phases of end-to end trial execution (planning, start-up, execution, data analysis, reporting, and closure)
• Work with the cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to effectively deliver assigned trials on time, on budget, and in regulatory compliance
• Additional opportunities include: 
  • Supporting the development of study-specific documents, plans, and manuals
  • Assisting in trial regulatory submissions and interactions, such as protocol amendments and responding to health authority and ethic committee Requests for Information
  • Participating in medical monitoring of clinical trial data and identifying trends in patient outcomes

* Pharmacy licensure is required by September 1st, 2027