Executive Director/Vice President, Technical Development And Operations

Executive Director/Vice President, Technical Development and Operations will join the executive management team and play a key role in leading the manufacturing of antibody oligonucleotide conjugates from Development candidate selection through Phase 3 transition and implementing cGMP operating principles including regulatory and quality assurance (QA). By leading an innovative, collaborative fast-paced group, you will be responsible for creating the vision, inspiring teams, and delivering on immediate and long-term goals for the department and organization. Must be a dynamic leader with outstanding communication, strategic and collaboration skills, ability to influence and a sense of urgency to deliver high-quality therapeutics to people with rare diseases.

• Lead and manage the drug substance and drug product development activities from development candidate, CTA/IND submission through the transition to Phase 3 at CMOs. Ensure that manufacturing meets all necessary technical specifications, timelines, budgets, and regulatory requirements.
• Lead external cell line development, optimization of antibody production including both upstream and downstream manufacturing.
• Collaboratively work with team members and functions in selection and management of CMOs for antibody production, oligonucleotide manufacturing, conjugation, formulation development, drug substance and drug product including writing RFPs, contract negotiation, and management of the projects once approved.
• Provide technical leadership to ensure that technical development and production will meet IND through Phase 2 global clinical supply needs and all appropriate global regulatory requirements.
• Provide support to regulatory interactions on CMC related topics. Manage writing and review of technical CMC documents for regulatory filings (CTAs, IND, BLAs, MAA) and participating in cross-functional, interdisciplinary product development teams.
• Responsible for the QA oversight of day-to-day GMP Operations at the CMOs for entry into the clinic through Phase 2.
• Ensure all US, EU, and other suppliers are compliant with local and international regulatory and import/export requirements by working closely regulatory leadership.
• Schedule, plan and prepare CMO for audits; along with internal processes, submission documents etc. in accordance with the audit plan or as requested.
• Assist with GMP inspection readiness activities for regulatory authority inspections and coordinate tracking of document requests, responses, and supporting documentation during inspections.
• Provide support for supply planning, procurement and forecasting of demand, to guarantee resource requirements are met.
• Manage the supply of drug product for Phase 1 through entry into Phase 3 through accurate inventory management.
• Responsible for risk reduction measures through effective risk mitigation programs that focus on appropriate second source strategies, increasing capacities of vendors and shortening supply chain cycle times.
• Maintain working knowledge of current FDA, EU, and other global regulation and guidance governing Good Manufacturing Practice (GMP), Pharmacovigilance (PV) and Good Laboratory Practice (GLP) activities.

• Experience and ability to lead an innovative, collaborative, dynamic team.
• Excellent communication (verbal and written) and interpersonal skills with the ability to clearly communicate and influence at all levels within the organization.
• Ability to think strategically and translate strategies into actionable plans.
• Takes responsibility, drives for results and achieves expected outcome.
• Experience compiling and writing technical packages for regulatory filings including a working knowledge of cGMP manufacturing and all applicable FDA and EMA regulations.
• Experience with BLA filings is strongly preferred
• Demonstrated ability to manage multiple development projects and CMOs simultaneously.
• Experience generating and overseeing development plans for drug product from preclinical through transition to Phase 3 clinical development.
• Demonstrate excellent leadership skills.
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Outstanding people management, and effective talent development.
• Leadership experience in a small company environment is desirable.
• Ability to work well in a deadline-driven environment.

Education and Experience:

PhD equivalent experience required

• Minimum 10 years in a management role within CMC
• Minimum 15 years of experience in pharmaceutical / biotech