Your mission
As a Drug Substance Manager
- you will be part of our CMC management team supporting all development projects with respect to managing clinical and commercial drug supply ensuring product quality managing CMOs / CDMOs / CROs and preparing CMC documentation for regulatory dossiers.
Responsibilities
CMO / CDMO / CRO management for API manufacturing of small molecules and Tides (mainly Oligonucleotides) for clinical study supply and early commercial phasesManagement of all aspects of technical drug substance development (eg analytics solid state assessment impurity profiling route finding)Supply chain management of APIs Regulatory Starting Materials and other critical reagentsCMC project management including clinical supply demand and timeline planning and representation of CMC in project teamsSelection and evaluation of suitable CMOs / CDMOs / CROs for GMP manufacture and testingCost of good assessment support of commercial phase preparation and postapproval activitiesSupport of regulatory fillings in US and EU (eg CTD module 3 and review of quality documentation relevant for manufacturing and testing (eg MBR validation protocols)Close interaction with QA / QC to manage CAPAs change controls quality incidents and participating in audits as technical expertYour profile
PhD (or equivalent) in Chemistry or Pharmaceutical Technology or similarAt least 5 years of professional experience in the pharmaceutical / biotech industryProfound experience in CMC development for early and latephase programs specifically with drug substance related activitiesExperience in CMO / CDMO / CRO management and collaboration with external partnersExperience with supporting regulatory filings in US and EUSound expertise in GMPcompliant drug substance manufacturing and testing including validation and transferAbility to efficiently evaluate prioritize and handle multiple project tasksHighly motivated and ability to work independently as well as in the teamExcellent organizational and communication skillsBusiness fluent in English; German skills would be beneficialWhy us
Unique corporate culture : Scientific excellence a collaborative working environment and the passion to improve the lives of patients defines our work. With us you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity inspiration as well as trustful collaboration.Development : We encourage people to grow and strongly support individual development and learning opportunities.Flexibility : Embracing flexible working accommodations we enable our people to integrate business into their personal life.Benefits : Employerfunded pension comes along with an attractive benefits packageAbout us
AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product PREVYMIS marketed by our partner MSD treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people an otherwise manageable infection can mean life or death. AiCuris with its expertise and growing pipeline is committed to providing therapeutic solutions for them now and in the future.
Passionate about our mission to develop antiinfective therapeutics for patients in need a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency where feedback is considered an opportunity to contribute to each others personal and professional growth. We hire people who are collaborative adaptable communicate well and love to learn.
AiCuris is an employer that supports equal opportunities diversity and inclusion. We welcome applications from people regardless of their national origin skin color religion gender age marital status disability sexual orientation gender identity or other legally protected characteristics.Required Experience :
Chief
Key Skills
Digital Marketing,Information Systems,F&B,Biomedical,Air Conditioning
Employment Type : Full-Time
Experience : years
Vacancy : 1
