You oversee external bioanalytical studies, ensuring compliance and quality while managing relationships with CROs. Your role includes strategic planning, method validation, and contributing to regulatory documentation.
Anforderungen
- •Master’s degree in analytical chemistry
- •Ph.D. or equivalent qualification preferred
- •Extensive relevant industry experience in bioanalysis
- •Strong scientific expertise in SMOL bioanalysis
- •Additional knowledge in biologics preferred
- •Knowledge of peptides or advanced modalities is a plus
- •Proven experience in international teams
- •Managing collaborations with external partners
- •Solid track record in regulated environments
- •Broad understanding of global drug development processes
- •Strong organizational skills
- •Excellent networking ability
- •Collaborative mindset
- •Strong proficiency in English (written and spoken)
Deine Aufgaben
- •Manage the selection of external providers.
- •Plan and execute outsourced small molecule bioanalytical studies.
- •Monitor CRO performance for timely, high-quality data.
- •Review critical tasks and reporting with CROs.
- •Evaluate transfer, development, and validation of bioanalytical methods.
- •Design bioanalytical strategies for new drug candidates.
- •Collaborate with PCD leads and clinical teams.
- •Oversee CRO operations ensuring compliance with quality standards.
- •Maintain strong relationships with CROs through communication and visits.
- •Implement best practices for CRO interaction and oversight of KPIs.
- •Coordinate with internal labs and the Toxicology Outsourcing group.
- •Contribute to regulatory documents and write expert statements.
Deine Vorteile
Competitive compensation package
Flexible work arrangements
Childcare support and summer camps
Access to learning and development
Free health check-ups
Inclusive work environment
Original Beschreibung
**Bioanalytical Outcourcing Expert (all genders)**
Join Bayer Pharmaceuticals in Berlin or Wuppertal as a Bioanalytical Outsourcing Expert (all genders) and play a key role in managing and optimizing outsourced small molecule bioanalytical studies. You'll drive CRO selection, ensure timely and high-quality data delivery, and contribute to the development of bioanalytical strategies for new drug candidates. This position offers close collaboration with internal labs, QA, and international partners in an innovative environment.
**YOUR TASKS AND RESPONSIBILITIES**
* You manage the selection of external providers and ensure effective planning and execution of outsourced small molecule (SMOL) bioanalytical studies
* Monitoring CRO performance is key—you review critical tasks to guarantee timely, high-quality data and reporting
* Your function includes review of transfer, development and validation of bioanalytical methods at CROs, including (cross)-validation
* You design bioanalytical strategies for new drug candidates in alignment with PCD leads and clinical teams
* In close collaboration with Bayer Quality Assurance, regulatory, and biosample management teams, you oversee CRO operations to ensure compliance
* Part of your responsibilities are maintaining strong relationships with CROs, including regular communication and on-site visits
* You implement best practices for CRO interaction using alliance management principles and oversee KPIs through annual reviews
* You coordinate with internal bioanalytical labs and the Toxicology Outsourcing group to ensure alignment on external TK bioanalysis and evaluations
* You contribute to regulatory documents by writing expert statements in IND, IMPDS, NDAs and prepare answers to regulatory requests
**WHO YOU ARE**
* You hold a Master’s degree in analytical chemistry, pharmacy, or natural sciences; a Ph.D. or equivalent qualification is preferred
* Extensive relevant industry experience in bioanalysis within a pharmaceutical setting have equipped you with strong scientific expertise in SMOL bioanalysis
* Additional knowledge in biologics, peptides, or advanced modalities like cell and gene therapy is a plus
* You bring proven experience working in international, cross-functional teams and managing collaborations with external partners
* A solid track record in regulated environments (GxP) is essential
* You demonstrate a broad understanding of global drug discovery and development processes
* Strong organizational skills, excellent networking ability, and a collaborative mindset define your working style
* You have strong proficiency in English (written and spoken)
**WHAT WE OFFER**
Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: **What matters to you, matters to us!**
* We ensure your **financial stability** through a competitive compensation package, consisting of an attractive base pay, our performance based company bonus and a global, equity-based cash plan with a four-year duration. In addition, managers can recognize special contributions by granting an individual performance award.
* Whether it’s hybrid work models or part-time arrangements: Whenever it is possible, you will have the **flexibility** to work how, when and where it is best for you.
* Your **family** is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more.
* We support your **professional growth** by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs.
* We support your **health** and **well-being** with free check-ups by our company doctor, health seminars, and a wide range of initiatives that promote a healthy lifestyle.
* We embrace diversity by providing an **inclusive work environment** in which you are welcomed, supported, and encouraged to bring your whole self to work.
Be You. Be Bayer.
**Location:** Germany : North Rhine Westfalia : Wuppertal-Elberfeld
**Division:** Pharmaceuticals
**Reference Code:**847500