Operational Lead Development Pk Bioanalysis Belgium

il y a 3 semaines

Beerse, Belgique Johnson & Johnson Temps plein

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. _
- We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. _
- That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. _
- Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong” _

**Operational Lead Development PK Bioanalysis Belgium**

**The Head of Development PK bioanalysis will**:

- Provide scientific and operational support for assay development and quantitative bioanalysis of preclinical (non-GLP) and clinical First-in-Human (FIH) studies at the Belgium based lab.
- Continuously optimize operational performance, efficiency and excellence of the lab (turn
- around times, resource and instrument planning, documentation, electronic archival, implementation of new LIMS system, IT software strategy, instrument validation, automation)
- Bring in innovative technologies where needed to support the portfolio
- Interact with our CRO partners for assay transfer and troubleshooting
- Ensure GCP compliance for FIH studies in accordance to ICHM10
- Actively participate and contribute to internal regional and global meetings
- Connect with stakeholders in non-clinical safety, DMPK, clinical pharmacology, quality assurance
- Actively interact/collaborate with BDDS US and EU groups and DMPK Analytical Science group
- Provide scientific visibility and recognition for Janssen through publications and scientific presentations internally and at major scientific and industry meetings
- Be involved in due diligence assessments
- Have a desire for learning and innovation, and continued career development

The Head of Development PK Bioanalysis will be part of the BDDS leadership team and could serve as needed as delegate leadership for the Global Head of Development PK Bioanalysis. The leader will have opportunity to be considered as part of BDDS succession plans.

The leader will be a manager of managers (Senior Scientists and Scientists) with an overall group size of ~16 FTE and have responsibility for the group in Belgium. The leader must be a role model of the company’s commitment to equal employment opportunity and the value of a diverse workforce.

Approximate Percentage of Time Tasks/Duties/Responsibilities

70% Leader of the Belgium based Development PK Bioanalysis group, includes the hiring and managing of staff, planning for laboratory needs and workflows, and assures prioritization of work targeted towards impactful portfolio work

10% Anticipate future bioanalytical needs and develop proactive strategies and executable plans for assuring pipeline support

10% Member of the BDDS leadership team and contributes to strategic and long-range planning for BDDS and staff development/needs

5% Interface with leaders and peers in other R&D teams (eg. Therapeutic Areas, Preclinical Sciences & Translational Safety, Clinical Pharmacology, Regulatory Affairs, etc.) as a thought leader and to provide ideas on portfolio, non-clinical safety, clinical, and regulatory strategy.

5% Serves as BDDS representative to a therapeutic area portfolio governance

100% Total

Participates in cross-functional strategic teams, special activities for innovation centers, external outreach and talent scouting, Janssen leadership representation at external science forums.

**Key Working Relationships**

Identify the most important working relationships with people inside and outside the company including customers, vendors, associations, etc. Briefly describe the nature of the contacts.

Internal: BDDS, DMPK, Non-Clinical Safety, Therapeutic Discovery, Clinical Pharmacology, Regulatory Affairs, Quality Assurance.

External: Academic, CROs, instrument companies, and industry-wide bioanalytical leadership groups/consortia, partners for innovation in business development.

**Supervisory Responsibilities**

List number of employees reporting to this position, both directly and through direct reports.

Direct Reports: 5 Indirect Reports: 40

Decision Making Authority - Check all appropriate decision-making authority level for this position:
1 Makes hiring recommendations

1 Makes hiring decisions

1 Trains employees

1 Plans work of others

1 Reviews work quality and quantity of others

1 Conducts performance reviews

1 Makes pay and promotional recommendations

1 Makes pay and promotional decisions

1 Resolves employee grievances

1 Makes termination recommendations

1 Makes termination decisions

1 Recommends budget amou

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