Drug Substance Manager* (Reporting to the Vice President CMC & IP)

Permanent employee, Full-time · Hybrid

Your mission

As a Drug Substance Manager* you will be responsible for the co-ordination of all GMP-related internal and external Drug Substance-activities for all the AiCuris small molecule research and development projects.

Responsibilities

CRO/CMO Management of API Manufacturing of Small Molecules and Tides (mainly Oligonucleotides)
Project Management Support, including demand/timeline planning and Legal support (CDA, POs, MSA, others)
Physio-chemical property assessment and feasibility studies
Route-finding and process development activities with external partners
Support of internal project teams in the candidate selection phase
Supervising solid phase assessments (Polymorph and salt/co-crystal screening), selection of appropriate development form
Due Diligences of CMC related information for new in-licensing candidates
Selection and evaluation of suitable GMP CROs
Supply chain management of APIs, RSMs (Regulatory Starting Materials), and other critical reagents
Cost of good assessment and support of commercial phase preparation
Supervising external CROs during the GMP manufacturing phase for clinical study supply and early commercial phases
Specific experience in impurity profiling and assessment
Documentation and quality control of all dossier-relevant reports (external and internal ones) including Master Batch records and Analytical Validation Protocols and Reports
Supervising the preparation of regulatory documents (IMPDs, CTD Module 3 documentation for drug substance, support IP preparation)
Organizing of GMP audits, selection of auditors, and participating as technical expert in audits
Management and support of external consultants
Close interaction with QA/QC and regulatory department to follow up CAPAs, change controls and any other related activities in the drug substance manufacturing process, support of QP release
Update of all relevant internal SOPs and preparation of new SOPs for further quality improvement
Support of patent team to generate new IP during development and during commercial phase
Experience in post-approval activities
Representation of CMC activities in internal and external project team meetings
Representation of AiCuris’ CMC team at conferences, exhibitions and CRO/CMO meetings

Your profile

PhD (or other adequate title) in Chemistry or other adequate title
More than 3 years proven experience in her/his area of responsibility with specific focus on process development and GMP manufacturing
Broad experience in route scouting and proven records in process development with additional experience in green chemistry trends
State of the art knowledge in industrial process chemistry (modern and scalable synthesis experience)
Leadership skills leading a team of at least 2-5 people
Experience in different regulatory areas: EMA, FDA and other authorities
Regulatory experience with proven record in Quality Control activities
Experience in CTD Module 3 writing for EMA and FDA submission
Support of regulatory dossier writers and agencies
Sound expertise in route finding, process development, GMP manufacturing for clinical study supply and early commercial phase, analytical method development and validation is essential
Ability to efficiently evaluate, prioritize and handle multiple project tasks
Experience in managing alliances with international external partners
Highly motivated, able to work independently and in a team
Ability to lead larger (project) teams having sole responsibility
Ability to think strategically about projects and business issues
Strong analytical and project management skills
Business fluent in English; German skills would be beneficial

Why 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: Employer-funded pension comes along with an attractive benefits package

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About 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 anti-infective 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 other's 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.

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Your application!

We appreciate your interest in our company. Please fill in the following short form. Should you have any difficulties in uploading your files, please contact us by mail at jobs@Aicuris.com.