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. Learn more at https: //www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Geel, Antwerp, Belgium, Gent, East Flanders, Belgium, Ghent, East Flanders, Belgium, Leiden, Netherlands, Leiden, South Holland, Netherlands

Job Description:

Within Johnson & Johnson Innovative Medicine Supply Chain, we are recruiting a skilled and enthusiastic senior scientist as QC New Product Introduction (NPI) Analytical Integrator (M/F/X) to join our dynamic Quality team, overseeing the development and manufacturing of Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product (DP) Intermediates in Geel, Belgium.

You are part of the QC NPI team responsible for the transfer, optimization, and co-validation of analytical methods for new products. As QC NPI Analytical Integrator, you are responsible for both project management and hands-on analytical work in support of the launch and commercialization of new SM-API and DP Intermediates. You act as the bridge between R& D, Supply Chain and the QC laboratories, ensuring seamless integration and execution of analytical strategies for new products.

Job Description:

• Perform hands-on laboratory work, including sample preparation, instrument operation, and data analysis.

• Organize, coordinate and follow-up on analytical transfer activities in the QC lab, including writing, reviewing and/or approving raw data, investigation records, CAPAs, Change Controls, protocols, reports, methods, specifications, and procedures.

• Review, test, and optimize new analytical methods, both chromatographic and non-chromatographic, to support feasibility, transfer, in process control (IPC), development process control (DPC) and release testing activities.

• Troubleshoot and resolve analytical issues, ensuring accurate and reliable results. Assure appropriate product and analytical knowledge and provide training to colleagues.

• Act as QC point of contact for the assigned NPI product portfolio. Establish and maintain strong working relationships with partners and key stakeholders, including R& D, Supply Chain and Quality partners.

• Oversee and manage the NPI product strategy for QC, effectively translating needs into actionable tasks, deliverables, and timelines, while also ensuring lab readiness.

• Prepare and present project updates and reports to management and other stakeholders, represent QC in NPI review meetings, and actively engage in scientific meetings and stage gate reviews.

• Adhere to established operating procedures, safety regulations, and company work standards. Write or review and approve work instructions and procedures for QC NPI activities.

• Serve as analytical integrator and strategist in crisis management situations.

• Act as (back-up) SME for analytical method transfer and compendial verification testing.

• Ensure inspection readiness and act as spokesperson during audits and inspections.

Qualifications:

• Master Scientific degree (chemistry, pharmaceutical sciences, engineer…) with at least 5 years of experience in pharmaceutical analytical development and/or QC testing, or equivalent experience performing progressively advanced duties beyond a Bachelor of Science degree.

• Hands-on laboratory experience with a sound technical knowledge of analytical techniques and related laboratory instruments, such as HPLC, GC, MS, NIR, etc.

• Strong problem-solving skills, analytical thinking skills and attention to detail.

• Ability to quickly assimilate new analytical technologies.

• Demonstrated proficiency in project management. Proven experience leading analytical projects is an asset.

• Demonstrated ability to simultaneously manage multiple tasks and work in a dynamic and volatile environment where scope, timelines and priorities can quickly change. Ability to independently make risk-based decisions under time pressure.

• Demonstrated ability to collaborate across organizational boundaries through influencing, negotiation, and partnering, with essential skills in communication and presentation across all levels of the organization.

• Comprehensive understanding of cGMP (domestic & international) and ICH guidelines. Experience with regulatory inspections and audit readiness is an asset.

• Fluency in Dutch and English languages.