Principal Scientist

**Job Description**:
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 130-year legacy. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

For a bioanalytical collaboration between our Human Health and Animal Health research divisions, we are establishing a bioanalytical laboratory at our Animal Health R&D site in **Schwabenheim (near Mainz)**.

We are looking for an experienced and motivated individual with expertise operating in a regulated laboratory to lead bioanalytical studies as Study Director/Principal Investigator (M/F/d) supporting human clinical studies.

In this position you will support our Clinical Pharmacokinetics Bioanalytical team on a** permanent and full-time basis**.

As the **Principal Scientist (M/F/d) Clinical Regulated Bioanalytics in Human Health **your responsibilities and tasks will include (but are not limited to):

- Be responsible to lead bioanalytical studies as study director / principal investigator and ensure compliance to all applicable guidelines and regulations
- Ensure GLP compliance. Write and/or review Bioanalytical reports, Validation reports and assay protocols
- Independently Initiate and manage the development, validation, and execution of state-of-the-art LC/MS assays
- Scientifically interpret and report bioanalytical results and support the preparation of dossiers for submission to the authorities
- Assumption of project responsibility in bioanalytical aspects, e.g., by participating in project team meetings as a bioanalytical expert to contribute bioanalytical-regulatory expertise
- Scientific interpretation and authority-compliant reporting of the analysis results in documents relevant to approval as well as the drafting of regulatory dossiers

**Your Profile**:

- Ph.D. Biology, Immunology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with a minimum of 7 years of relevant industry experience, or M.S. in chemistry/biochemistry with a minimum of 10 years of relevant industry experience
- Experience working within a regulated laboratory preferably in a GxP bioanalytical lab
- A minimum of 5 years of experience in quantitative LC/MS-based bioanalysis of therapeutic compounds (LBA experience is a plus)
- Highly proficient with LIMS systems (e.g., Watson is preferred)
- Knowledge of first-in-human studies is a plus
- Prior experience preparing bioanalytical sections of regulatory submissions as well as experience interacting with regulatory agencies is a plus
- Authorized Person in accordance with German biological substances regulation (- 44 IfSG) or several years of experience working with human biohazard materials is a plus
- Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators
- Ability to work efficiently and to adapt to changes in assignments consistent with new or changing project priorities
- Highly organized, and capable of multitasking to manage multiple projects while meeting challenging milestones
- Experience in disciplinary leadership is a plus
- Willingness to travel to the US for training and flexibility of work hours

Applicants with alternative combination of academic/experience requirements with a minimum of 5 years of experience as a Principal Investigator in the regulated bioanalytical laboratory are encouraged to apply.

**Our Benefits**:

- Flextime (37.5 hours/week)
- Competitive salary package: 13 monthly salaries, plus target bonus
- Holiday allowance (1.200€ annually)
- 30 days holiday entitlement
- Attractive company pension scheme
- Corporate benefits
- On-the-job training and development opportunities

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
Domestic

**VISA Sponsorship**:
No

**Travel Requirements**:
10%

**Flexible Work Arrangements**:
Flex Time, On-Site

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
N/A
**Requisition ID**:R251258