Du leitest ein Team, das analytische Methoden entwickelt und technische Probleme löst, während du regulatorische Anforderungen beachtest.
Anforderungen
- •Ph.D. in Analytical Chemistry
- •Long-term R&D experience
- •Experience in developing analytical methods
- •Skilled in troubleshooting assay issues
- •Expertise in conducting studies for data generation
- •Agile and collaborative mindset
- •Ability to work with cross-functional teams
- •Strong leadership and influencing skills
Deine Aufgaben
- •Führung des MSAT Pharma Analytics-Teams übernehmen
- •Analytische Wissenschaftler weltweit leiten
- •Technische Probleme untersuchen und beheben
- •Analytische Methoden für Produkte entwickeln und validieren
- •Studien entwerfen und Daten auswerten
- •Komplexe Fertigungs- und Qualitätsprobleme lösen
- •Zusammenarbeit mit externen Labors und Partnern leiten
- •Regulatorische Anforderungen für analytische Methoden verstehen
- •Ein kleines Team von Direktraportierenden managen
Original Beschreibung
# Head of MSAT Pharma Analytics
## The Position
Join Boehringer Ingelheim as a Senior Leader and spearhead the establishment of a new group focused on identifying and solving pharmaceutical manufacturing and analytical challenges. In this role, you will lead efforts to ensure our products meet global regulatory standards, facilitate knowledge transfer to maintain market supply, and prevent significant compliance issues. Your expertise will also drive the optimization of our pharmaceutical analytical methods, enhancing quality control and upholding our commitment to excellence. This is your chance to make a pivotal impact on the health and well-being of patients worldwide.
## Tasks & responsibilities
* One of your responsibilities will be providing leadership and direction to the MSAT Pharma Analytics team and analytical scientists globally to meet business needs efficiently.
* You will lead teams in investigating and troubleshooting technical issues, developing and validating analytical methods for commercial products, including APIs and finished goods, both internally and at CMOs worldwide.
* In addition, you will utilize strong scientific and seasoned analytical skills to design studies, evaluate data, and resolve complex manufacturing/Quality issues while maintaining GMP standards. You will direct and collaborate with external laboratories and partners to execute the studies you and your team designed.
* Furthermore, you will apply broad knowledge and experience with regulatory filings, including understanding regulatory requirements and guidelines related to Analytical Methods and specifications.
* You will initially manage a small team of direct reports, guiding their efforts in supporting the company's analytical and regulatory objectives.
## Requirements
* Ph.D. or equivalent in Analytical Chemistry, Chemical Sciences, or Pharmaceutical Sciences
* Long term experience in R&D or Operations with a proven track record in developing analytical methods as well as troubleshooting analytical assay issues across manufacturing sites
* Skilled in root cause analysis for manufacturing discrepancies where APIs or finished products do not meet specifications
* Expertise in designing and conducting studies to generate data for problem identification, documentation, and solution provision to manufacturing operations
* Agile and collaborative, with the ability to work effectively with cross-functional teams, including R&D, Regulatory Affairs, Quality, and Manufacturing Operations
* Strong ability to lead teams and influence partners which are not directly under your supervision