Verflixt! Es sieht so aus, als wenn Sie einen veralteten Browser benutzen. Wir empfehlen Ihnen dringend Ihren Browser zu aktualisieren.
Weitere Informationen über Browser und Updates finden Sie hier

Senior Manager Tech Transfer & External Pharmaceutical Manufacture (m/f)

We are a Germany based specialty pharmaceutical with a highly innovative and proprietary drug delivery technology platform called EyeSol®, focusing on ophthalmology. Our mission is to transform poorly soluble drugs into effective ocular therapeutics for both front and back of the eye. Our first OTC product is marketed within Europe since Q4 2015. Our most advanced prescription candidate is currently being tested in a large phase II US trial in moderate to severe dry Eye disease. Within our development we further focus on drug candidates based on our disruptive technology platform for the application in Glaucoma, Retinal diseases and beyond.
 
Novaliq GmbH in Heidelberg is currently looking for a Scientist to establish and manage external CMOs for pharmaceutical manufacturing activities in order to support our clinical and commercial product development program:
 
Senior Manager
Tech Transfer & External Pharmaceutical Manufacture (m/f)
 
Main responsibilities:
  • Establishing robust, efficient external pharmaceutical supply chains for successful new product launches from development through to commercial
  • Establishing and liaising with CMOs to ensure that scope, executing and reporting of validation meets expectations
  • Developing product target profiles and validating master plans
  • Transferring pharmaceutical research projects into final drug products
  • Ensuring that program controls meet global quality standards and applicable regulatory requirements
  • Reviewing protocols and reports for completeness, cGMP compliance and acceptability of data
  • Managing external validation resources to facilitate project completion
 
Your profile:
  • MSc in Pharmaceutical Sciences, preferably PhD
  • 7+ years’ experience in drug product manufacturing and validation (including aseptic filling experience)
  • Solid understanding of FDA, EU, and ICH cGMP guidelines and industry best practices
  • Excellent understanding of validation and qualification principles and standards with demonstrated ability to apply these to GMP operations
  • Ability to solve problems, understand cGMPs, exhibit excellent interpersonal skills and prioritize multiple tasks
  • Working knowledge of manufacturing processes, validation, and change control concepts for pharmaceutical manufacturing
  • Experience in the compilation of regulatory submissions (CTA, IND etc.)
  • Proven history of working with several CMOs and be able to discuss key criteria for the selection of a suitable CMO
  • Willingness to travel frequently and to work with our CMOs
  • Competent handling of MS Office applications
  • Strong collaborative team spirit, self-motivated and track record of reporting skills
  • Strong and open communication skills
  • German/English of international working standard
 
This is an excellent opportunity for the right candidate to be part of an exciting, growing company and the option to directly contribute to and benefit from the success of the organization.  A competitive salary will be offered dependent on experience. 
 
Please send your written application in English, stating the reference number SM-0416 via e-mail to
jobs@novaliq.com.
 

Kontaktdaten


Art des Bewerbungszugangs

Please send your written application in English, stating the reference number SM-0416 via e-mail to jobs@novaliq.com.
Kontakt für Bewerbungen

Novaliq GmbH
Im Neuenheimer Feld 515
D-69120 Heidelberg
Tel.: +49 (0)6221-50259-0
http://www.novaliq.com
 
 

Details der Stellenanzeige


Arbeitszeit
Vollzeit
Vertragslaufzeit
Festanstellung
Stellentyp
Fachkraft
Berufserfahrung
Berufserfahrung vorausgesetzt
Region
Deutschland (Baden-Württemberg)
Arbeitsort
69120 Heidelberg
Fachgebiet
Pharma, Biologie & Life Sciences, Chemie, Biotechnologie
JETZT BEWERBEN