Sr Laboratory Large Molecule Drug Product Process Scientist

This role supports life cycle management (LCM) and process optimization for large‑molecule parenteral products within MSAT global department. Execution of process development studies and supportive tech‑transfer tasks, analyzes process data, aids PAT/digital tool rollout and support Annex1 process changes. Ensures GMP/ICH compliance, and collaborates with cross‑functional and external partners. Prepare, review, and approve technical protocols, reports, and product impact assessments related to product lifecycle management (LCM) and 2nd TT. Apply and improve lab-scale models to evaluate process parameters and ranges; translate findings to scale up and confirm or adjust critical/key parameters. Analyze process data and access data driven changes for 2nd TT or LCM activities. Plan and execute process development studies in the lab on product to support lifecycle decisions for unit operation (freeze/thaw, mixing, filtration, filling). Lead filter validation activities with external partners. Support new technology, PAT and digital tool implementation to commercial processes. Ensure GMP/ICH compliance; document. Collaborate globally with cross functional teams and commercial supply chain to review process performance data in depth and drive process improvements. Enable MSAT digital capabilities and establish the LCM function by implementing tools, processes, and training to streamline scale‑up and support tech‑transfer and process changes.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• MSc/PhD in Pharmacy, Chemical Engineering, Biotechnology, or related; 5+ years in MSAT/LCM/Tech Transfer in pharma/biotech

• Strong hands‑on experience executing lab studies and process validations with external vendors/CMOs

• Skills on data‑evaluation using tools (e.g., JMP, Minitab, Excel)

• GXP experience in Pharma production and Laboratory

• Familiarity with GMP/ICH and systems like LIMS/MES/SAP; strong stakeholder management

• Proficient in English; German language skills are optional

• Creative, flexible and open-minded

• Familiarity with GMP/ICH and systems like LIMS/MES/SAP; strong stakeholder management