Sr Principal Scientist, Process Develop Full-time NEW

Senior Principal Scientist, Global Process Development, Drug Product Development & Delivery

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.

We are searching for the best talent for a Senior Principal Scientist, Global Process Development (GPD), Drug Product Development & Delivery (DPDD) 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 fill–finish 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 DPDD's 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 Bachelor's 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