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Senior Manager Pharmaceutical Development, Packaging and Scale-up (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 an experienced Scientist to provide operational leadership for the transfer of early research formulations into pilot scale pharmaceutical products:
 
Senior Manager
Pharmaceutical Development, Packaging and Scale-up (m/f)
 
Main responsibilities:
  • Define, develop and implement pharmaceutical scale-up strategies for ophthalmic drug products based on scientific, technical, regulatory, and market place needs
  • Lead the resolution of technical issues related to products in development or in commercialization
  • Define primary and secondary packing materials according to technical requirements and market needs
  • Coordinate project activities with other internal functions such as Regulatory Affairs, Quality Assurance, Analytical R&D, Sales/Marketing, etc.
  • Author, review and approve CMC related documentation as required for the market application
  • Lead, guide and direct in executing process optimization and validation studies
  • Interact with FDA/EMA regulatory authorities as required
  • Partner in continuous improvement projects
  • Contribute to department goals
 
Your profile:
  • MSc in Pharmaceutical Sciences, preferably a PhD
  • 7+ years’ experience in Drug Product development (preferably for ophthalmic drug products)
  • Solid understanding of FDA, EU, and ICH cGMP guidelines and industry best practices
  • Broad experience in pharmaceutical packing, preferably for multi dose eye droppers
  • Excellent understanding of validation and qualification principles and standards with demonstrated ability to apply these to GMP operations
  • Ability to solve problems, a solid understanding of cGMPs, exhibit excellent interpersonal skills and prioritize multiple task
  • Experience in the compilation of regulatory submissions (CTA, IND etc.)
  • Willingness to travel frequently
  • 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 SMPP-0416 via e-mail to
jobs@novaliq.com.
 

Kontaktdaten


Art des Bewerbungszugangs

Please send your written application in English, stating the reference number SMPP-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