Summary:Seeking a Director with expertise in early-stage fermentation development and late-stage Process Characterization (PC) to join the development team. Individual will lead the designing of upstream PC studies that to translate to a successful PPQ campaign. The person will oversee the upstream early phase pipeline programs.Essential Functions:Develop and execute upon a high-level plan for validating the upstream commercial manufacturing process for the components of phase II program.Works with process development team and the SMEs within the group and at CMO to complete risk assessments for critical process parameter identification.Design process characterization studies to assess the criticality of parameters and manage a team to execute.Will author Process Characterization reports and review PPQ protocols along with CMO counterparts.Partner with CMOs to develop a validation plan for at-scale validation of the protein manufacturing process and drive the plan.Partner with internal stakeholders (e.g., Regulatory) to ensure that the Upstream validation strategy aligns within the program-wide strategy.Work with pm team to maintain a detailed timeline for the activities that must be completed prior to a commercial PPQ campaign – let the team know when activities are at risk of causing delays to timeline.Lead the development of the upstream processes for pipeline vaccine-based components (will come from the Research team). Mature early-stage fermentation processes to be commercially ready. Lead a group of scientists and engineers that develop upstream processes from early stage to late stage within a world class upstream laboratory.Collaborate effectively with the downstream groups within development and manufacturing team.Represent upstream development at CMC meetings and with external partners.Requirements:PhD in Chemical/Biochemical Engineering or similar, with 7+ years of industry experience; MS with 10+ years of industry experience; or BS with 15+ years of industry experience.In depth experience with upstream process characterization work. i.e. risk assessments, identification of pCPPs, PC reports etc.Strong understanding of design and interpretation of multi-variate development experiments (e.g. Design of Experiments) with practical experience using software required for these experiments.Excellent judgment when assessing risk – strong understanding of when to expend resources to reduce risk and when the level of risk is acceptable to move forward.Excellent background in fermentation development demonstrated through years of industrial experience. Experience working with BSL2 organisms, Streptococcus pneumoniae and Escherichia coli a plus.Strong ability to motivate, mentor, and connect with junior team members.Strong sense of organization, preferably with experience managing timelines using a tool such as Microsoft Project.Ability to work across several teams to pull required information from SMEs and integrate it into centralized plan.Reports to: Senior Director, Process Development & Manufacturing Location: San Francisco Bay Area, CA (onsite) Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $211,000 – $225,000Enigma Search Solutions is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment.