Agomab

Drug Substance Manager

Agomab Antwerp, Flemish Region, Belgium
No longer accepting applications

Department: CMC

Employment Type: Full Time

Location: Agomab Antwerp

Description

We are looking for a Drug Substance Manager who will manage and monitor R&D activities within the Chemistry Manufacturing and Controls (CMC) area, focused on active pharmaceutical ingredients (API) such as but not limited to the following: chemical development, manufacturing, product release, control of stocks and deliveries, control of data generated as per current guidelines (cGMP, ICH) and regulations (EMA, USA FDA).

Key Responsibilities

What will you do?

Vendor Selection And Project Follow-up

  • Collaborate in the preparation of requests for proposals (RFP) for the projects;
  • Assist in the selection of the appropriate CRO/CDMO vendor;
  • Monitor vendor activities and organise follow-up meetings on regular basis.

Drug Substance And Process Development

  • Define the API development and manufacturing strategy in alignment with Global project/CMC plans;
  • Review the scope of work and results from R&D chemical development activities of APIs, radiolabelled compounds, impurities or related metabolites;
  • Support in the preparation and follow-up of CMC project plans and timelines based on Global project plans, with special focus on planned pre-clinical and clinical studies, regulatory submissions and future industrialisation objectives;
  • Review and when necessary approve development records, master manufacturing batch records, manufacturing protocols and the corresponding reports and product specifications.

GLP/GMP Manufacturing Of API Batches

  • Assist experts of other development areas in the company (e.g. pre-clinical, clinical, project management) to estimate the required API quantities and required quality to fulfil the Global Project Plans. Propose appropriate batch size and stocks necessary;
  • Monitor the progress of manufacturing activities;
  • Assure activities are performed according to GMP, SOPs and applicable regulations
  • Review executed records and CoA/CoC for compliance before batch release.

Regulatory Support

  • Organize and compile all the CMC Drug Substance specific supporting data in shared folders;
  • Author or collaborate to the CMC Drug Substance sections in regulatory submission documents such as IND, IMPD, IB.

Additional Responsibilities

  • Assist Head of Departments and Project Managers in the overall plan and budgeting process, by contributing with the CMC/API inputs.

Skills, Knowledge And Expertise

  • Organic Chemist (Master degree or PhD) or equivalent qualification with 10 years' pharmaceutical industry experience;
  • Hands-on experience on scale-up processes and industrialisation of APIs;
  • Knowledge of the technical concepts and interpretation of results for the following analytical chemistry techniques: NMR, IR, UV, HPLC, GC, LC/MS, PSD, XRD, and DSC;
  • Regulatory and project management experience;
  • Knowledge of development of pharmaceutical products;
  • Writing skills focused on technical and regulatory documents.
  • Knowledge of and experience in cGMP requirements and international regulations (ICH, EMA; US FDA), and applicable regulatory and QA CMC documents.
  • Understand protocols, SOPs, and technical knowledge of the manufacturing and testing of the drug substance.

Benefits

  • The opportunity to develop pioneering science in a young biotech company
  • Challenging and innovative work environment as part of a driven team
  • Flexibility and responsibility based in Antwerp with remote working options that can be tailored for you
  • Competitive salary and benefits
  • An agile and fast paced environment
  • Seniority level

    Mid-Senior level
  • Employment type

    Full-time
  • Job function

    Other
  • Industries

    Biotechnology Research

Referrals increase your chances of interviewing at Agomab by 2x

See who you know

Get notified about new Manager jobs in Antwerp, Flemish Region, Belgium.

Sign in to create job alert

Similar jobs

People also viewed

Explore collaborative articles

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Explore More