CuriRx, Inc. was founded in 2012 with the goal of creating new standards of care in therapeutic areas with high unmet medical needs. We do this by partnering with our clients to provide innovative development solutions for pharmaceutics, biopharmaceutics, vaccines, generics, and biosimilars.
This is an outstanding opportunity for a motivated, career-minded individual to join a fast-paced contract research organization in improving the lives of patients globally by transforming scientific discoveries into medicines.
CuriRx is seeking an experienced scientist/engineer to lead the Bioprocess R&D team to support bioreactor/fermentation and downstream process development activities. He/she will be responsible for developing and improving bioprocesses for new and existing products, as well as transferring processes to other contract manufacturing facilities. The Bioprocess Director will serve as a subject matter expert and technical lead for developing upstream and downstream processes supporting clients and partners drug development efforts.
The focus of this role is to direct and oversee process development for the production of bulk drug substance and the initial clinical manufacturing initiatives. This position requires a strong working knowledge of manufacturing processes as well as experience across CMC functions with an emphasis on process development. The right candidate will also have the expertise needed to ensure all processes are consistent with regulatory requirements per the FDA, EU, and other international agencies.
Duties and Responsibilities
- Direct upstream and downstream process development, ensuring that all process development is conducted within current industry standards and regulations.
- Oversee biologics drug substance development and manufacturing processes, tech transfer and scale-up; identify and implement opportunities for process improvement.
- As technicallead and subject-matter expert (SME), assess and resolve technical issues related to biologics drug substance development and manufacturing operations.
- Incorporate Quality-by-Design (QbD) into developing processes.
- Manage project plans and timelines for multiple development projects, ensuring the timely completion of project goals.
- Evaluate technical concepts and methodologies, new unit operations, data analysis techniques and tools.
- Lead process automation and equipment validation related to biologics drug substance manufacturing.
- Review and approve applicable product batch documentation
- Establish critical process parameters (CPPs), and critical quality attributes (CQAs) for developing processes.
- Oversee and provide leadership for process development and clinical manufacturing functions in cross-functional team forums.
- Hire and mentor staff, ensuring that all direct reports perform to expected levels and achieve established objectives.
- Forge relationships with external resources and consultants
- Establish standard operating procedures, guidelines, expectations, and documents for the R&D group
- Present analytical results and development activities to clients.
The successful candidate will have:
- Extensive hands-on experience in upstream and downstream process development. Knowledge of regulatory aspects for both Biologics License Applications (BLAs) and biosimilars.
- Strong analytical skills and ability to distill key information from various data sources.
- Experience bringing products to commercialization
- A successful record of R&D accomplishments and peer-reviewed publications
- Demonstrated understanding of industry trends, practices, techniques, and standards
- Proven ability to drive technical strategy as well as lead cross-functional teams.
- Exceptional people management and leadership skills.
- Strong communication (oral and written) and organizational skills.
- Experience with external CRO or CMO management
- Proven ability to operate with a high level of ambiguity while making sound and timely decisions based on project priorities and risk assessments.
- Proven ability to complete projects on time and within budget
- Ph.D. (preferred) in bioengineering/biological sciences with 12-16 years of relevant experience; or M.S. degree with 14-18 years of industrial experience, or B.S. degree with 16+ years of industrial experience.
- Strong knowledge of biologics manufacturing, including significant hands on experience in the areas of cell culture, protein expression, isolation, purification and characterization.
- Breadth of knowledge across cell culture technologies, cell culture, fermentation processing technologies, cell characterization methods, manufacturing under cGMP, validation, quality systems and regulatory requirements.
- Demonstrated in-depth skills in DOE and factorial design, and execution and analysis in support of process scale and optimization.
- Experience authoring CMC sections of CMC regulatory documents.
- Proficiency with MS Office applications; advanced knowledge of Excel and MS Project.
CuriRx is an equal opportunity employer and supports workplace diversity, a reduced carbon footprint, and fun
Job Type: Full-time
- Wilmington, MA (Preferred)
- Paid time off
- Parental leave
- Health insurance
- Dental insurance