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Job Description:

Major duties/responsibilities:

• Lead one of the sub-team of Higi ONE AD organization, which is tasked with developing and validating chromatographic methods for all late-stage synthetic compounds in the portfolio of the Higi ONE AD team. This includes method transfers, overseeing stability studies, conducting clinical release and stability testing and providing the analytical reports required for NDA/MAA filings, such as test method description, validation and stability reports.
• Performing late-stage development activities at Higi site which is just before the filing/submission will require working in a GMP environment, supporting different Health Authority inspections.
• He/she will collaborate with the other sub team leaders under Higi ONE AD organization to ensure that similar practices and methodologies are employed for all compounds supported by the Higi ONE AD organization.
• People Development: Identify training needs and opportunities for team members, provide coaching, and support their professional development to enhance skills relevant to method development/validation and stability studies.
• Project Management: Oversee the planning and execution of method validation, transfers and stability studies, ensuring high quality output, timely delivery of results and compliance with regulations.
• Manage the team' s budget and resources effectively, ensuring cost-efficient use of technologies and materials.
• Strategic Planning: Develop and refine the overall strategy for the team aligned with organizational goals, ensuring that method validation, transfers and stability studies meet required standards.
• Team Leadership: Foster a positive team environment by providing direction, motivation, and support to team members. Facilitate collaboration, both within Higi AD and with external teams, and ensure clear communication within the teams.

Other Duties:

• Direct Responsible Individual for new modality programs (ADC’s, Peptides). In this role, he/she is the Single Point of Contact for other departments for their programs.
• Strengthen the interface between Analytical Development and key stakeholders (PQM, IMSC).

Key Working Relationships:

• Team Leader of other Higi ONE AD sub-teams – direct colleagues, collaboration to ensure that similar practices and methodologies are employed for all compounds supported by the Higi ONE AD.
• IMSC-Quality & PQM – Partner with IMSC-Q function at Higi site and PQM as Quality partners for our R& D business.
• Team Leaders AMSC Beerse – Partnering and collaboration with team leads colleagues from AMSC Beerse to ensure flawless transfer and execution from early phase to late phase development of our Synthetics portfolio.
• Head Analytical Development AMSC, Scientific Sr Director – The AMSC team at Beerse is engaged in early development projects that starts with method development and then transitioning to Higi the late phase development activities.

Education, Skills and Experience:

Required Minimum Education: Ph.D /Equivalent by Experience with Master’s Degree in relevant area

Required Years of Related Experience: 10 years of related experience

People Management experience of 5 years

Required Knowledge, Skills and Abilities:

• In depth knowledge of Chromatographic techniques
• In depth knowledge of API and DP development processes
• Regulatory guidelines and requirements in support of clinical studies and NDA/MAA filings
• Experience of working in cGMP environment
• English fluency (oral and written)

Preferred Knowledge, Skills and Abilities:

• Method development and validation process (ICH Q2 and ICH Q3 series)
• Stability studies (ICH Q1 series)
• Strong experience in compliance (audits, inspections, …)

Supervisory Responsibilities

• Direct Reports: 3-5
• Indirect Reports: 22 J& J and about 25 Non-J& J