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We are looking for a highly motivated person who drives new technologies and processes. The candidate will develop drug product formulations and scalable manufacturing processes for NBEs used in clinical trials through all phases of development. Working closely with analytical and formulation scientists in an integrated group the candidate will operate via multi-functional, global teams including API manufacturing, Process R&D, Pre-formulation and Pilot Plant Operations.
Major Responsibilities
- The incumbent will participate in the development of parenteral formulation for monoclonal antibodies and antibody drug conjugates,
- Independently design and execute studies evaluating the stability (chemical & physical) of the monoclonal antibodies and antibody constructs/conjugates against solution conditions (pH, ionic strength, temperature, light e.tc) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, filtration and Lyophilization), and screen excipients (buffers, stabilizers, surfactants, tonicity & Tg’ modifiers e.t.c) to develop robust formulations for frozen, refrigerated liquid and lyophilized dosage forms
- Perform upfront manufacturability assessment of the formulation candidates and recommend the best and back up formulation for both FIH and commercialization
- Make concise scientific presentations of experimental results to the management and author detailed scientific technical reports.
- Author CMC relevant sections of INDs/CTDs, as well as response questions
- scientific project lead, generating original technical ideas for formulation and analytical technologies of assigned NBE development projects
- Establishment and coordination of external development activities including supervision of technical, financial and regulatory requirements
Basic:
- BS and typically 10+ years of experience; MS or equivalent education with typically 8+ years of experience; PhD 0+ years of experience in formulation or analytical development of NBEs
- Scientific understanding of the structure & function of monoclonal antibodies and antibody constructs/conjugates, and their modes of degradation/stabilization
- An understanding of scientific approach to develop biologic protein formulations
- Strong lab skills focused on formulation development for monoclonal antibodies and antibody constructs/conjugates (standard excipient selection, functional excipients, high throughput assays)
- Basic understanding of unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling and lyophilization for liquid and lyophilized NBEs
- Hands on expertise of bio analytical test methods for protein pharmaceuticals e.g. mass-spectrometry, HPLC and electrophoretic methods, particle imaging, ELISA, compendial tests
- Broad expertise around regulatory requirements for NBEs (mAbs, bispecifics, ADCs) and parenteral products is preferred (21 CFR parts 600 & 210, FDA cGMP-, ICH-, EU GMP-guidances).
- Statistical knowledge and experience is preferred e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies
All your information will be kept confidential according to EEO guidelines.
