MSAT Synthetics Liquid DP External site Principal Scientist

Johnson & Johnson Innovative Medicine; Beerse; Hybride; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Well-being programs

Résumé du poste

Johnson & Johnson Innovative Medicine is hiring an MSAT Synthetics DP External Site Pr. Scientist in Beerse, Belgium. You will lead technical oversight for external manufacturing sites and manage due diligence, audits, and onboarding, driving product lifecycle, NPI and tech transfers.

You will collaborate with EM partners, MSAT teams, and QA to deploy new technologies, assess risks, and ensure compliance with GMP and regulatory expectations across multiple sites and products.

Qualifications

• Minimum 8 years of relevant work experience in pharma manufacturing.
• Experience with dosage forms and process science; tech transfer of liquids and solids.
• Experience with external manufacturing networks (EM) and site onboarding.
• Knowledge of GMP and regulatory requirements in pharmaceutical manufacturing.

Responsabilités

• Execute drug product technology transfer and lifecycle activities.
• Support NPIs and tech transfers with EM sites and VMT.
• Act as technical coordinator for EM tech standards and MSAT roadmaps.
• Serve as site owner for technical issues and represent MSAT in VMT.
• Monitor ongoing and planned technical activities at the EM site.
• Provide technical support for investigations, deviations, and OOS.

Connaissances

8+ years experience

Process engineering

Tech transfer

External manufacturing

GMP knowledge

Strong communication

Formation

Bachelor’s degree in Engineering/Pharma

Master’s or PhD preferred

Outils

Quality systems

Data analysis

Description du poste

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

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.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium, Latina, Italy

Job Description:

Johnson & Johnson Inc. is recruiting for an MSAT Synthetics Drug Product External site Pr. Scientist

MSAT (Manufacturing Science and Technology) is a division of the Innovative Medicine Supply Chain (IMSC) of Johnson & Johnson. MSAT is a worldwide organization with members located across the geography in close vicinity to the Internal Manufacturing Network (MTO) and External Manufacturers, providing Technical Competence and Manufacturing Excellence to Johnson and Johnson’s pharmaceutical environment and product portfolio.

The MSAT Synthetics DP External Site Pr. Scientist is responsible for providing technical oversight to external manufacturing (EM) sites. They will also be responsible for site ownership in performing due diligence, auditing, and site onboarding. The Scientist will conduct technical/risk assessment, execution, and/or oversight of New Product Introduction (NPI), technical transfers, and Product Life Cycle (LCM) management. They will be involved with standards and new technology deployment, Multi-Variate Analysis (MVA) & statistical analysis, Proactive assessments and de-risking of products and process through collaboration with various other MSAT teams, different functions, and partners.

Key Responsibilities:

• Handle execution of drug product technology transfer, product life cycle activities, material qualification, and cleaning validation
• Support NPI using applicable tools and standards in collaboration with Virtual Management Team (VMT), key supply chain functions, Technical launch integrators / owners, and EM site
• Act as Technical coordinator for CMO process technology proficiency assessment, technology standards, and implementation of MSAT Technology Roadmaps
• Serve as primary contact and site owner for technical issues related to EM and represent in VMT by being a single technical voice including EM, thus supporting decision / actions
• Maintain and develop good understanding of the status regarding ongoing and future planned technical activities at site
• Engage in Site Lifecycle processes (due diligence / selection, onboarding, engage, ongoing monitoring, disengage) including support to localization; also be involved in technical assessment / due diligence of product portfolio / in- licensing
• Support working models and tools in handling EM from technical perspective which includes Technical risk metrics & Switching Effort / Complexity metric for fit-for-purpose segmentation model, and account planning/adherence
• Conduct technical assessment of change controls and other quality related activities by associating with Quality for audits and inspections
• Provide technical support on site for investigations and resolution of deviation / OOS (process, cleaning, troubleshooting) by collaborating with engineering, product launch, and technical owners

Qualifications:

Education:

• Minimum of a Bachelor’s/University or equivalent degree required; Master’s or PhD and/or focused degree specialization in Engineering, Pharmaceutical Science, or equivalent technical subject is preferred

Experience and Skills:

Required:

• Minimum 8 years of relevant work experience
• Demonstrated experience/expertise with various dosage forms, including experience in process science and tech transfer of Liquid & solids manufacturing technology.
• Experience working with external manufacturing network (EM)
• Basic knowledge of Small Molecule Supply chain (products, customers, suppliers, plants)
• Strong communication and teamwork/networking skills with the ability to interact at different levels of the organization/sector
• Ability to lead activities under general direction, and demonstrate a good sense of prioritization of assigned tasks & goals and handle time accordingly
• Strong understanding and knowledge of Q&C (Quality & Compliance) and the regulatory requirements (e.g., GMP, EHSS, etc.) related to pharmaceutical manufacturing environment

Preferred:

• Experience in specialized technology which includes Freeze dried tablets, Softgel capsules etc., new pharmaceutical manufacturing technology especially continuous manufacturing or related technology
• Understanding and application knowledge in statistics and process excellence / investigation tools

Other:

• May require up to 25% travel, domestic and/or international depending on business needs
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week and depending on business needs

#SCEngineer
#LI-MV2

Required Skills:

Preferred Skills:

The anticipated pay range for this position, in the primary posting location, is:

€79,800.00 - €137,770.00

The anticipated pay ranges for additional locations are:

Italy – The anticipated base pay range for this position is €56,100.00 – €96,945.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.