Drug Product Project Leader (Parenteral Drug Product Development)

Novartis Farmacéutica; Basel-Stadt; Vor Ort; CHF 120’000 - 160’000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Basel seeks a Drug Product Project Leader to oversee innovative parenteral drug development. This role involves strategic project leadership, managing formulation processes, and ensuring compliance with industry standards. Ideal candidates will have a Ph.D. or Master's in relevant fields and extensive experience in drug product development.

Qualifikationen

• 7+ years of industry experience in parenteral drug product development.
• Broad understanding of pharmaceutical sciences and development processes.
• Familiarity with pre-filling syringes and combination products is an advantage.

Aufgaben

• Lead complex Drug Product Development projects within the PHAD Specialty Unit.
• Manage formulation and process development activities for parenteral products.
• Develop and monitor project strategies and timelines.

Kenntnisse

Scientific leadership

Data Analysis

Data Visualization

Quality by Design

Process Analytical Technology

Ausbildung

Ph.D. in Chemistry, Chemical Engineering, or Pharmaceutical Technology

Master's degree in related disciplines

Tools

Statistical software

Jobbeschreibung

Drug Product Project Leader (Parenteral Drug Product Development)

Job ID REQ-10051450

May 12, 2025

Summary

Location: Basel, Switzerland

Role Purpose:
Join the Pharmaceutical Development (PHAD) Specialty Unit as an Associate Director – Drug Product Project Leader (DPPL) for drug product formulation and process development of parenteral innovative medicines, especially xRNA therapeutics and radioligand therapies (RLT). Advance the technology platform for both xRNA and RLTs and contribute to the development of patient-centric drugs. The position is ideal for an individual who is passionate about bringing transformational medicines to patients and working on exciting novel pharmaceutical products.

The PHAD Specialty Unit is seeking an experienced Drug Product Project Leader (DPPL) to lead DP development sub-teams, be accountable for the DP development project strategy and represent DP development in the global CMC project team! Apply now and be a part of a team that is revolutionizing drug product development.

About the Role

Responsibilities

• As Drug Product Project Leader be the strategic lead of complex Drug Product Development projects (e.g. for Oligonucleotides or RLTs) within the PHAD Specialty Unit
• Lead and manage all formulation and process development activities for parenteral formulation development and parenteral manufacturing.
• Represent DP project teams in global CMC teams, providing strong quality awareness, scientific expertise, and project management skills.
• Develop a sound DP project strategy, including contingency planning and risk assessments, in line with overall Technical R&D project plan and guidelines.
• Monitor project plans and ensures timely availability of agreed timelines.
• Contribute actively to network deliverables and cross-functional initiatives, promoting collaboration and knowledge sharing.
• Act as an author, reviewer, or approver for PHAD owned documents, supporting submission writing and addressing inspection requirements.
• Ensures adherence to the EP/ LP project review process and high-quality documentation through relevant governance boards.
• Leads the Transfer Team and clinical development activities in alignment with TDP for late phase and LCM projects.
• Leads and / or contributes actively to respective Network deliverables and cross-functional workstreams/initiatives.
• Assesses, consolidates and negotiates resource needs (internal & external costs) and timelines. Lead budgeting process for DP activities.

Requirements

• Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Technology or related disciplines with 7+ years of industry experience in parenteral drug product development, e.g. for Oligonucleotides (mRNA, siRNA, ASO) or Biologics (ADC, proteins), OR Master's degree with 9+ years of biopharmaceutical industry experience.
• Broad and profound understanding of development activities and processes in pharmaceutical sciences (parenteral, aseptic, solution, and/or suspension)
• Strong knowledge of laboratory and/or technical tools ((e.g., Quality by Design, statistical software, Process Analytical Technology).
• Familiarity with devices such as pre-filling syringes, vials, and combination products is an advantage.
• Strong scientific leadership skills.
• Basic / Advanced skills in Data Analysis and Data Visualization, including application of data science tools
• Strong knowledge of relevant GLP, GMP regulations and policies requirements in parenteral Drug Product development and manufacturing.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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