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 fellowship will include elements of formulation, manufacturing, delivery design, and strategy for novel biologics including antibody, cell, and gene therapies. Additionally, fellows will gain experience in clinical trial development.

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/.
 

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, engineers, and pharmacists 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 2025.

This fellowship offers a two-fold experience in which the fellow will be exposed to the following:

Biotherapeutic Drug Product Development (~75% of experience)

• Plan and lead a 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, ancillary compatibility, product stability, delivery feasibility, and dose accuracy
• Utilize pharmacy knowledge to provide clinical insight on preparation and administration techniques that impact instructional training for investigational sites
• Identify areas of risks to patients based on preparation and administration strategies to ensure positive outcomes in clinical trials
• Collaborate with scientists to optimize drug products, and engage with cross-functional team members to address complex formulation, manufacturing, and delivery challenges
• Author technical reports, maintain laboratory notebooks, and present project findings
• Conduct literature searches and present updates on current clinical practices to scientific teams to incorporate a patient and provider-centric approach to the drug development process
   

Clinical Trial Development (~25% of experience)

• Support the development of at least one clinical trial, with opportunity to gain exposure to various phases of end-to end trial execution (planning, start-up, execution, data analysis, reporting, and closure)
• Support 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 a compliant manner
• Additional responsibilities may include but are not limited to:
  • Supporting the development of study-specific documents, plans, and manuals
  • Assisting with external vendor selection and set-up, including ensuring that scope of work and specifications are consistent with protocol requirements, budget, and timelines
  • Supporting risk identification and mitigation strategy creation and roll-out within a clinical trial
  • Working with internal partners to assist in management of activities such as country and site feasibility
  • Assisting in trial regulatory submissions and interactions, such as protocol amendments and responding to health authority and ethic committee Requests for Information
  • Collaborate across all members of the cross-functional team, including members from clinical operations, clinical pharmacology, biostatistics, regulatory affairs, and data management
  • Participating in medical monitoring of clinical trial data and identifying trends in patient outcomes
  • Supporting other activities as delegated by the study team
     

*Pharmacy licensure is required by September 1st, 2025