Technical Operations and Manufacturing is a critical strategic priority for Torque, and the inventions and process development advances are a core component of the Deep Priming technology platform. We are creating this new leadership role to head our Analytical Development, Process Development, MS&T, cGMP Manufacturing teams to ensure the technical functions work seamlessly together.  In addition, this position will play a key role in asserting the vision for the manufacturing platform both within the company, and externally with key stakeholders:  our investors, partners, and investigators/KOL's. 

This role requires collaborating with internal teams, partners, contract organizations and consultants to deliver process and analytics technology transfers internally and externally, technical support of cGMP operations, production process scale, continuous improvement projects, process robustness enhancement, COGs reduction, process scale up strategy, strategic business and operations process development, among other opportunities that surface.

Responsibilities:

• Provide critical production process technical support for the cGMP manufacturing clinical drug product for commercial biologics and cell therapy
• Lead and manage process validation design, protocol preparation and review, IND/NDA/BLA filing reviews, while serving as SME (Subject Matter Expert) for CMC issues and initiatives
• Resolve all cGMP issues effectively including discrepancy investigation and CAPAs, change control and management, product (DS and DP) release, tech transfer reports, key process development reports and continuous improvement project report
• Lead, direct and manage the manufacturing function to meet, exceed and support business goals
• Manage and plan budget, projects, personnel and schedules to perform specific projects according to deliverables and overall priorities
• Design organization and recruit key talents to strengthen manpower capabilities and technical depth
• Coach, mentor and develop key staff systematically with career path definition, career planning, training regimen to achieve high performance consistently
• Build and establish appropriate processes and systems to consistently improve operating productivity and efficiency
• Support business development in project evaluation, due diligence and providing technical inputs to potential projects
• Drive strong collaboration and communication across Operations, Quality and Product Development Tech Transfer teams to implement new projects.
• Lead process external tech transfers from Biologics and/or cell therapy to external partners and third parties such as CMOs
• Develop new manufacturing technologies with PD groups
• Introduce new manufacturing technologies to streamline operations, improve yields, enhance quality (cGMP) and lead “disruptive technology” development.
• Routinely present and publish in international conferences on behalf of company to build strong positive reputation and perceptions while gathering industrial intelligence

Ideal Experience for this role:

Ph.D. degree in relevant biological sciences and/or engineering, such as molecular biology, analytical and biochemistry, protein chemistry or biological engineering, biochemical engineering with minimum of 15 years industry experience in the pharmaceutical and/or biotechnology industries.

• Proven leadership skills and track records of success in managing technical groups and teams to meet objectives under resource constraints and time sensitive pressure

• Excellent communication, documentation and technical writing skills

• Demonstrated experience in CMC & Manufacturing Sciences for producing clinical and commercial biopharmaceuticals

• Proven records and ability in process development, productivity improvement and cGMP biologics manufacturing

• Familiarity of regulatory issues pertaining to the manufacture of biologics, large scale biopharmaceutical unit operations and process validation

• Excellent technical background with full range of biologics process development, production processes, cGMP biologics manufacturing, state-of-the-art analytical sciences and technologies

• Deep appreciation and broad understanding of cGMP and practices for biologics

• Demonstrated leadership skills in coaching, managing, mentoring and developing high performance staff to fully explore their potential