Job Summary
CTO/ Vice President/Head (VP), Technical Operations will report to the CEO and have a high degree of visibility and expected impact across the organization. The successful candidate will bring a strong strategic and quality mindset to this leadership role and has a proven track record managing risk and leading technical operations, including drug substance and drug product process and analytical development, and clinical manufacturing and supply. S/he will oversee and provide technical guidance, strategic direction, and long-range planning in the execution of all CMC (Chemistry, Manufacturing and Controls) and related activities from IND-enabling studies to BLA. S/he will be responsible for and have experience with the development and implementation of efficient and effective CMC strategies, building CDMO relationships, and ensuring excellence in process and product development, including controls, and compliance with regulatory guidance.
The ideal candidate will seek to build inter department synergy using excellence in communication, will be highly motivated, and have substantial CMC experience developing biologic drugs, ideally with cell based modalities. S/he will derive motivation from working in a small, entrepreneurial biotech environment, accepting the challenge of broad responsibilities and opportunities within a fast-paced, matrix-focused can-do culture. A “hands-on” operational approach and ability to deliver on corporate goals integrating internal and external, virtual resources lay at the core of this role.
Key Position Objectives & Candidate Criteria
- The ideal candidate will have strong biologics/large molecule CMC experience across multiple functional areas. Experience with Cell Therapies is required
- This individual will lead biologics drug development and manufacturing, including all CMC functional areas – cell culture development, biopharma development, and drug product and analytical sciences, and support business development of the Novel program
- This individual will organize and provide oversight of internal CMC activities at in-house CMC laboratories as well as all outsourced biologics CMC activities at contract development and manufacturing organizations (CDMO) and Contract Testing Organizations (CTOs)
- The candidate is experienced in managing change and is a strong team leader with excellent communication skills and an ability to work effectively with others, both cross functionally within the company, with consultants, and with external partners
- The candidate will be a hands-on leader who can build successful and sustainable processes, instill operational excellence, and build out and nurture the TO team
- As a part of the Senior Leadership Team, this individual will have access to members of the C-Suite on a regular basis and will play an integral role in all tactical initiatives and strategic
Key Responsibilities
- Develop and implement a sustainable and adaptable CMC strategy for each clinical candidate and support business development of the Novel program. Lead CMC activities from IND-enabling studies to late clinical development (ultimately to BLA), ensuring full executive management engagement in key decisions and effective communications to all stakeholders
- Build or adapt the operational tools, systems, and communication channels necessary for alignment of the TO department with broader program teams, as well as Research, Vector Production, Finance and Legal/IP, to achieve the corporate goals and quality objectives
- Lead, mentor and further develop the TO team with a strong team-based culture and commitment to scientific and operational excellence in alignment with individual, departmental, and corporate goals
- Provide input into the regulatory affairs strategy for the product portfolio; lead the development, review, and approval of all CMC sections in regulatory filings
- Participate in meetings with the relevant global health authorities, conveying the appropriate compliance with GMP and other standards
- Meet the needs of internal stakeholders for appropriately packaged and labeled clinical supplies through Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs)
- Oversee the review of all CMC-relevant documents, such as technical reports, batch records, protocols, and change controls to ensure compliance with all applicable regulations and industry standards for the development of drug substances and drug products
- Proactively identify potential risks to CMC timelines and deliverables and communicate/implement effective risk mitigation strategies
- Oversee management of external subject matter experts in the areas of CMC regulatory strategy, pharmaceutical development and manufacturing, and analytical development, and department budgets
Qualifications
- Advanced (MS/MES/PhD) degree in Biology, Chemistry, Chemical Engineering, Pharmaceutical Sciences or related technical discipline, as well as a minimum of 15 years’ experience in the Biotech / Pharmaceutical industry, ideally in a senior manufacturing and process development technical leadership role within the cell therapy industry, with 10+ years managing a CMC function, modalities and small, virtual biotech experience preferred
- Demonstrated general ability applying fundamental scientific and engineering know how for crafting innovative and practical solutions to technical challenges
- Demonstrated ability creating and executing strategies for successful product development through effective management of CMOs/CTOs resources
- Substantial experience with cGMP manufacturing and testing of pharmaceuticals from early through advanced clinical development; ability to manage and simultaneously advance multiple tasks/projects and pivot in strategy and operational execution
- Knowledge of cGMP regulations and CMC-relevant ICH guidance documents as well as experience in the preparation and defense of CMC regulatory documents
- Skilled in clearly conveying complex concepts and study results in written and verbal form to a range of audiences, such as peers, executive management, regulatory agencies, and intellectual property attorneys
- Highly motivated, ethical and professional self-starter with strong interpersonal skills and a quality and sense of urgency mindset, who is capable of influence and negotiation with stakeholders to successfully prosecute the completion of projects per timeline
- Demonstrated, motivational leadership leading technical teams within a highly matrixed environment; ability to articulate vision and successfully drive execution
qualified candidates should email resume / CV to jobs@tseworldwide.com