Position: MSAT Biotherapeutics Drug Substance (MSAT Bio DS) Fellow / Scientific Director – Supply Chain Engineering – Manufacturing Engineering, People Leader
Location: Malvern, US; Cork, Ireland; Leiden, The Netherlands (global scope). The role is onsite/hybrid and available across multiple countries.
Johnson & Johnson is committed to an inclusive work environment and respects the diversity and dignity of all employees. We are an equal opportunity employer.
Key ResponsibilitiesScientific & Technical Leadership- Acts as a recognized internal and external subject matter expert with direct impact on scientific and business objectives.
- Provides scientific leadership across drug substance development, commercialization and lifecycle management, understanding impact of process parameters on product quality attributes.
- Defines and shapes scientific strategy for programs, projects and technologies, ensuring technically sound and innovative approaches are embedded into business application.
- Proactively shapes control strategies for commercial and late‑lifecycle biologics DS processes, owning platform alignment.
- Works in close partnership with MSAT site teams and global MSAT functions, ensuring strong alignment between site execution and global technical strategy.
- Fosters cross‑MSAT collaboration across platforms (Launch & Growth, Value Optimization, Labs, Material Sciences), enabling sharing of best practices, harmonized standards and accelerated learning.
- Builds trust‑based partnerships with Operations, Quality, R&D, Regulatory, Planning, PES and external manufacturing partners to drive integrated, right‑first‑time delivery.
- Promotes a One‑MSAT attitude, strengthening collaboration between site‑based and global teams to deliver consistent, high‑quality outcomes.
- Leads technical and scientific activities across value optimization and late lifecycle portfolios, including investigations, continuous improvement initiatives and complex lifecycle changes.
- Identifies, assesses and resolves high‑impact, complex and cross‑functional scientific and technical issues, establishing clear decision points and risk‑based paths forward.
- Creates, manages and prioritizes multiple complex programs and projects delivering high‑quality outcomes aligned with business objectives.
- Partners with R&D organizations to translate development knowledge into robust MSAT processes and manufacturing solutions, providing feedback from CPV trends and manufacturing lessons learned.
- Brings a strong innovative attitude, actively seeking new concepts, technologies and approaches to improve process robustness, efficiency and sustainability.
- Champions harmonization, digital enablement, advanced analytics and new ways of working to future‑proof DS manufacturing and lifecycle management.
- Encourages scientific curiosity, continuous improvement and thoughtful challenge of the status quo to deliver long‑term value for patients and the business.
- Is accountable for post‑approval submissions and contributes to health authority interactions.
- Leads the preparation and review of regulatory documents, presentations and responses, acting as senior scientific author and reviewer.
- Maintains current knowledge of global regulatory guidelines and health authority expectations related to biologics drug substance.
- Leads and mentors scientific and technical talent across MSAT Bio DS, acting as a technical role model and mentor.
- Has indirect people leadership responsibility, including matrix teams, outsourced activities and external partners.
- Drives development of intellectual capital, continuous learning and capability building within the function.
- Actively seeks opportunities to improve business processes, scientific rigor and operational excellence.
- Communicates overall scientific and technical strategy clearly across site and global forums.
- Serves as a key liaison between project teams, MSAT leadership, senior business partners and cross‑functional partners.
- Influences across functions and senior leadership through scientific credibility and collaborative leadership.
- Negotiates and builds alignment around new ideas, approaches and concepts through sound scientific reasoning.
- Contributes to budget and resource allocation for programs and projects.
- Sets and monitors priorities, timelines, resources and risks across complex technical portfolios.
- Influences the initiation, development and termination of projects to ensure optimal scientific and business outcomes.
- Advises on existing procedures and assesses opportunities for improvement across products and processes.
- Directs appropriate introduction and implementation of new technologies to ensure long‑term competitiveness.
- Master’s degree or PhD in Chemistry, Biochemistry, Biotechnology, Chemical Engineering or related field (or equivalent experience).
- Minimum of 12 years of experience in biotherapeutics drug substance development and/or manufacturing, including people leadership experience.
- In‑depth experience in protein‑based therapeutics, including process development, analytics and scale‑up.
- Proven experience authoring and reviewing CTA and BLA submissions.
- Strong track record of leading complex scientific and technical teams in a global, matrixed environment.
Preferred: Excellent written and verbal communication skills with demonstrated ability to influence peers, leaders and partners. Self‑motivated, resilient leader with strong problem‑solving capabilities and an innovative, improvement‑driven mindset.
What We OfferLeading a multifaceted leadership opportunity in a dynamic, international environment. Role at the forefront of biologics manufacturing science with opportunities for continued professional growth.
Required Skills- Business Planning
- Developing Others
- Facility Management
- Inclusive Leadership
- Leadership
- Leading Change
- Lean Manufacturing Principles
- Lean Supply Chain Management
- Manufacturing Compliance
- Manufacturing Engineering
- Manufacturing Flow Management
- Performance Measurement
- Predictive Maintenance
- Product Design
- Report Writing
- Safety‑Oriented
- Science, Technology, Engineering, and Math (STEM) Application
- Same as Required Skills
€101,000.00 – €174,800.00 (primary posting location). In Ireland: €104,000 – €179,515.
Benefits- Annual bonus with set target (% of pay) based on employee and company performance or sales commissions.
- Vacation days.
- Parental leave of at least 12 weeks.
- Bereavement leave, caregiver leave, volunteer leave.
- Well‑being reimbursement and programs for financial, physical and mental health.
- Service anniversary and recognition awards.
- Eligible insurance plans for employees and, in certain locations, eligible dependents.
- 8% holiday allowance included in base pay.
Salarisomschrijving
€101000 - €174800 monthly