Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team! This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily responsible for scientific leadership and technical oversight of upstream and downstream process design, development, and scalability of unit operations necessary for supporting the Target product profile of the vaccine candidates in development. This role is within a team of highly experienced scientists with an opportunity to drive IND submission of early-stage assets. As a CMC development lead, the individual will apply their strong expertise in CMC fermentation and/or purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. This position is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.
Responsibilities include but are not limited to:
Effectively function as a CMC lead generating original technical ideas and development strategies.
Provide scientific and technical leadership of early-stage assets to design and develop scalable upstream and downstream processes using QbD and PAT tools.
Responsible for development, characterization, scale-up and support of drug substance processes to enable advancement of programs.
Develop robust CMC development plans, Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation
Expand and develop skills in microbial fermentation, scale up and purification, thereby further contributing to the integrated group.
Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase appropriate manner.
Make significant contributions to project team through lab-based activities.
Proactively seek out new tools, techniques, and strategies to implement into individual programs(s)
Be hands-on and execute lab and small-scale operations to meet project deliverables.
Transfer processes to GMP manufacturing.
Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals and presenting work at scientific conferences.
Work efficiently, collaboratively, and cross-functionally toward project timelines and goals.
Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment.
Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness.
Identify and lead additional development activities and manufacturing through various phases of product development.
Participate in efforts to define, manage, and/or complete innovation projects that advance technical capabilities, refine & establish platform manufacturing processes.
Generate documentation for experimental reports to support technology transfer and regulatory filings (development and technical report writing).
Communicate technical information and project progress to the Senior leadership and external partners.
Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
Preferred Qualifications:
Must be a subject matter expert in microbial fermentation (yeast). Additional experience in downstream purification of biologics including chromatography separations and filtration operations (depth, dead-end, and ultrafiltration/diafiltration) is a plus.
Direct experience in designing, planning and executing feed strategies for increased yield and productivity,
Proficiency in Mandarin
Strong understanding of analytical techniques using HPLC, ELISA and mass spectrometry based methods
Requirements:
PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 8 years in the bio/pharmaceutical manufacturing environment. MS with 10+ years of relevant experience in MSAT or process development of biologics /vaccines may also be considered.
Direct experience in microbial expression systems (yeast) is a must.
Technical expertise in development and full-scale manufacture of recombinant biologic products. Direct experience in Vaccine development and Phase 1-3 readiness support is highly desirable.
Excellent communication skills, both written and oral.
Proficiency in statistical software for data analysis and tracking and trending.
Other:
Seeking Boston local candidates to be on-site 3-4 days per week.
Travel (5-10%) may be required to CMO, CRO and key vendor for process and product development purposes.