A leading biotech in the novel vaccine space is looking for a motivated and skilled individual to join their Vaccine Product Development organization as an Associate Director of Downstream development and manufacturing within the Protein Development and Manufacturing group. The successful candidate will have the following skills and qualities:
- A dynamic leader who can establish a team and move the pipeline forward while building a team and developing workers.
- A terrific team player who collaborates well with others, speaks up when necessary, and keeps focused on achieving the best results possible in order to accomplish company goals.
- A scientific thought leader capable of synthesizing difficult challenges into well-designed experiments capable of illuminating the unknown; capable of planning and executing with the help of a team.
- The capacity to synthesize and evaluate data in order to form conclusions, make sound judgments, and explain key points succinctly
- A strong sense of ownership and accountability
- Take the lead in creating a downstream purification process for early stage vaccine candidates, the purification method must be robust, scalable, and cost-effective.
- Spend ~50% time in the lab
- You'll be responsible for a group of 2-3 direct reports.
- Develop and implement tests to assess product quality in collaboration with Analytical Development, including innovative product concentration assays.
- Participate in cross-functional project teams and report on progress on a regular basis.
- Lead technology transfer activities for process to an external CMO for GMP manufacturing.
- COVID-19 vaccination is required for all personnel.
- PhD in Chemical Engineering, Biochemistry, or a related discipline, with 5+ years of industry experience; MS with 10+ years of industry experience; or BS with 15+ years of industry experience
- In-depth expertise and experience with protein purification, including familiarity with AKTA lab-scale and preparative chromatography systems, as well as Unicorn software.
- Practical and theoretical knowledge of engineering principles involved in scaling processes from development lab to pilot / production plant are both required.
- Working knowledge of GMP production criteria; hands-on GMP experience a plus
- Experience working with CMOs highly desired; ability to effectively transfer processes to CMO, and to oversee development and manufacturing activities performed at CMO; ability to travel to CMO (some international travel required) to perform person-in-plant oversight activities
- Extensive hands-on experience purifying proteins from crude lysate to high purity
- Solid understanding of the principals of DoE (Design of Experiments); practical experience with DoE software; proficient in the design and interpretation of statistically modelled experiments.
- Experience with depth, nominal, and tangential flow filtration
- Ability and desire to learn upstream cell-free production system used to express proteins
- Proficiency running gel- and column-based analytical methods a plus; such methods may include SDS-PAGE, Western blotting, IEF, SEC, HIC, IEX, RP, Mass Spec, and binding affinity or activity assays (such as MSD or ELISA) Experience writing IND section(s) a plus
- Demonstrated success working in a cross-functional team environment on multiple projects; ability to work both on a team (as member and/or leader) and independently to deliver results
- Strong interpersonal skills, with excellent written and verbal communication skills
- Senior Director, Protein Process Development and Manufacturing