Senior Scientist II/III
The pharmaceutical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state of the art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We are looking for a highly motivated person for a drug product formulation lead position. The candidate will independently design and develop stable and robust drug product formulations and scalable manufacturing processes for NBEs used in clinical trials and commercial. In this role, the candidate will be part of a global team and will work closely with scientists from multiple functional areas, including Analytical, Process R&D, Pre-formulation and Manufacturing Science & Technology.
Key Responsibilities Include:
- Lead the formulation, drug product development and stability assessment activities of the assigned NBEs, including candidate screening and selection for clinical studies and commercialization of monoclonal antibodies, antibody drug conjugates, bispecifics and fusion proteins.
- Independently design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and Lyophilization), and screen excipients (buffers, stabilizers, surfactants, tonicity & Tg' modifiers etc.) 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 formulations for both clinical studies and for commercialization.
- Represent the formulation group in the CMC team. Prepare concise and sound scientific presentations of experimental results to the management and author detailed scientific technical reports.
- Author CMC sections of INDs/CTDs, and BLAs as well as responses to questions form regulatory agencies.
- Generate 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
- Stay current with the scientific literature and lead new scientific initiatives.
- Develop and author patents as needed.
Level will be based on education and years of experience
- Ph.D.in Chemistry, Biochemistry, Pharmaceutics, Pharmaceutical Sciences Chemical or Biomedical Engineering, or Materials Science (or related discipline), with 3+ years of industry experience in formulation and/or analytical development of NBEs, and a proven track record of publications in the field.
- Post-doctoral experience is preferred but not required.
- Scientific understanding of the structure & function of monoclonal antibodies, antibody constructs/conjugates, bispecifics and fusion proteins and their modes of degradation/stabilization.
- Solid understanding of the scientific approaches to develop commercially viable protein drug products
- Strong laboratory skills focused on formulation development for monoclonal antibodies and antibody constructs/conjugates (standard excipient selection, functional excipients, high throughput assays).
- Solid understanding of the various 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 analytical methods for chemical and structural characterization of protein pharmaceuticals e.g. HPLC, UPLC, capillary electrophoresis and biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, Raman spectroscopy, particle analysis, etc.) for protein characterization is a plus.
- 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-guidance).
- Knowledge and experience in statistical analysis is preferred e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies
Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
- Excellent oral communication skills in a scientific setting as well as sound technical writing and documentation competencies are required
- The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions;
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled