Sr Principal Scientist, Process Develop

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

Malvern PA USA - Requisition Number: R - 057858

Schaffhausen Switzerland - Requisition Number: R - 058708

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Job Description

We are searching for the best talent for a Senior Principal Scientist Global Process Development Drug Product Development & Delivery to be onsite in Malvern PA or Schaffhausen CH.

Purpose:

The Senior Principal Scientist Global Process Development (GPD) Drug Product Development & Delivery (DPDD) within Therapeutic Development and Supply (TDS) serves as a scientific individual contributor and Drug Product process subject-matter expert. The successful candidate will guide and influence the GPD team and the broader DPDD organization on process development scale-up and technology transfer for parenteral fillfinish manufacturing; criticality analyses and control strategies; regulatory strategies; and other topics relevant to various biologics assets (proteins). They will partner with Supply Chain Quality Regulatory and other functions to implement manufacturing processes that meet quality regulatory and commercial requirements.

You will be responsible for:

• Working independently across GPD DPDD TDS IMSC and other groups to shape and influence the drug product (DP) process landscape and build a portfolio of value-generating DP process opportunities.
• Coaching and mentoring junior scientists on DP process topics.
• Establishing and maintaining internal capabilities for biologics DP process development scale-up and technology transfer consistent with industry standards and best practices.
• Serving as strategist author contributor reviewer and approver of DP process sections in health authority submissions for biologics.
• Partnering with Supply Chain manufacturing site leads Quality Regulatory and GPD to ensure smooth transfer and introduction of manufacturing processes into production sites in compliance with regulatory requirements.
• Designing experiments to identify critical process parameters and proposing detailed control strategies aligned with regulatory expectations and sound business practices.
• Interpreting scientific data and conducting critical reviews of global process development study reports.
• Leading initiatives for best product/process readiness at launch (right-first-time) and for harmonization and optimization of process development and technology transfer.
• Participating in issue-resolution teams by engaging in scientific discussions and shaping strategies that inform critical development decisions.
• Contributing to DPDDs success and growth through active participation in internal and external committees and close collaboration with scientists in Formulation Development Drug Delivery Systems Analytical Development drug substance (API) development and CMC project leaders across the US EU and China.
• This is an individual contributor role

Qualifications / Requirements:

Education:

• Minimum of a Bachelors degree is required
• PhD in a technical field (e.g. Chemical Engineering Pharmaceutical Science Biochemistry) is highly preferred

Required:

• Minimum of 8 years of experience developing and commercializing parenteral biologic drug product processes.
• Technical expert on current manufacturing processes and equipment and engineering scaling principles with the ability to apply knowledge to technology transfer and process optimization aligned with HA-guidelines and GMP regulations.
• Prior experience in scientific data evaluation statistical analysis experimental design and execution including ideally at-scale and scientific writing/reviewing regulatory documents and technical reports across multiple complex programs.
• Strong written and verbal communication skills the ability to negotiate and influence decision-making processes think and manage issues to resolution and contribute to study teams and scientific discussions
• Proven personal leadership with a track record of influencing junior scientists peers and senior leaders; proactive and adaptable with a focus on urgency for patients; excels at collaboration and building inclusive team relationships.
• Ability to travel to support development and manufacturing projects at internal or external sites in US and EU (up to 10% travel project dependent)

Preferred:

• Demonstrated expertise in LCPV/criticality/control strategy development
• Track record of conceptualizing and leading innovation projects
• Experience with setting regulatory strategy and responding to written Health Authority questions

This job posting is anticipated to close on February 20 2026. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

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