Janssen Pharmaceuticals, Inc.
Biotherapeutic Drug Product & Clinical Trial Development Fellowship
Pharmaceutical Companies of 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 early-stage clinical trial development.
Janssen Research and Development, part of the Johnson & Johnson family of Companies, aims to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. At Janssen, we strive to foster a diverse, equitable, and inclusive environment consistent with our Credo values to bring out the highest potential of each contributing individual.
The Biotherapeutic Drug Product & Clinical Trial Development fellowship program provides the fellow with an opportunity to work on new modalities and technologies within Biotherapeutics Drug Product Development & Delivery. 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 the global trial development team to plan and execute early-stage clinical trials. We are recruiting one fellow for this program to begin in 2024.
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 complex early development drug study, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting, and closure)
- Collaborate with multi-functional groups (primary investigators, study responsible scientists, trial leaders, etc.) to ensure successful cross-functional delivery of the assigned global clinical trial
- Additional responsibilities may include but are not limited to:
- Authoring study-specific documents to be used during patient recruitment and clinical trial start-up
- Assisting with external vendor selection and set-up, including ensuring that scope of work and specifications are consistent with protocol requirements, budget, and timelines
- Coordinating and participating in internal and external study specific meetings as necessary to document outcomes, actions, and decisions
- Supporting risk identification and mitigation strategy creation and roll-out
- Working with internal partners to assist in management of activities such as country and site feasibility
- Ensuring that trial activities are consistent with global regulations and requirements
- Establishing transparent communications across all members of the cross-functional team
- Supporting other activities as delegated by the investigational drug trial management team
*Pharmacy licensure is required by September 1st, 2024
Simona Senovaityte, PharmD
Second Year Fellow
University of Colorado at Anschutz, Skaggs School of Pharmacy and Pharmaceutical Sciences
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Katelyn Grenell, PharmD
First Year Fellow
Duquesne University School of Pharmacy
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