We are looking for a highly motivated and enthusiastic Head BioProcess Scientist to join an emerging stage biotech company that is developing cutting edge vaccine technologies for HPV, and additional applications in multiple other indications. This is an exciting opportunity to drive the development of the next-generation of immune oncology biologics in a highly collegial environment.
You will lead all aspects of Chemistry, Manufacturing and Controls (CMC) development for the recombinant expression platform. This is a key leadership position that reports directly to the Chief Operations and Chief Executive Officer. You will be responsible for providing scientific expertise as well as leading the design, production and characterization of products from early pre-clinical development leading to a first-in-human clinical trial. Mentoring of junior scientists in the team is also expected. This is an exciting opportunity to drive the development of the next-generation of biologics within a highly collegial environment. A high level of responsibility, flexibility, and acceptance to constructive guidance is required to carry out the diverse duties of this position.
IN THIS ROLE, YOU WILL:
- Lead the BioProcess team in all aspects of Upstream and Downstream process development, engineering, expression, purification and characterization of recombinant candidates.
- Provide expertise and insight to guide the development of effective expression and purification strategies.
- Design and implement improvements in either compositions or formulations aligned to the research strategies.
- Mentor and guide junior team members in cell culture process characterization and validation.
- Mentor and guide junior team members in developing purification techniques as well as assays for biochemical characterization of candidates using a variety of techniques and tools.
- Analyze, document, and interpret scientific research and technical data.
- Meticulous attention to details, and be able to in author and follow standard operating procedures (SOPs) and Quality systems.
- Highly capable of maintaining detailed experimental records, and observing safety and sterility practices.
- Provide oversight of CMO qualification, tech-transfer, process development and cGMP manufacturing campaigns.
- Participate in audits and site visits to CMOs.
- Review and audit cGMP batch records.
- Write and compile CMC sections for pre-IND and IND submissions to FDA
EXPERIENCE AND SKILLS REQUIREMENTS:
- Experience in leading research teams.
- A desire to be part of a small, dynamic and growing team that is focused on delivering highly effective medicines to treat infectious diseases and/or Cancers.
- PhD in Biochemistry/Biophysics/Analytical Chemistry/Bioengineering or a related discipline with 3 - 5 years of relevant experience in industry.
- Relevant biotech industry experience with upstream processing of recombinant and/or fusion macro-proteins or molecules.
- Experience working with bioreactors at various scales, single use bioreactors (SUBs), scale-up and scale-down modeling.
- Proficiency with separation and purification techniques, including Hydrophobic Interaction Chromatography (HIC), Ion-exchange (IEX), Size Exclusion Chromatography (SEC), and affinity purification.
- Experience in developing and executing purification processes for large macromolecules using a variety of ultra/diafiltration, etc., and chromatographic techniques that are applicable to peptides, proteins, polysaccharides, nanoparticles, and bioconjugates.
- Well versed in analytical and bioanalytical techniques applicable to peptides, proteins, carbohydrates, bioconjugates: NMR, mass spectrometry, light scattering, HPLC, colorimetric techniques, etc.
- Preference will be given to those with experience with Quality systems, batch record execution and cGMP manufacturing
TO APPLY, PLEASE SUBMIT YOUR CV AND COVER LETTER.