This successful candidate will be responsible for delivering Biopharmaceutical Development strategies and leading cross functional teams required for the technology transfer, manufacture and release of Company's growing biopharmaceutical products. The Manager/Associate Director will principally support the Company’s development of biologics by overseeing the successful completion of chemistry, manufacturing and controls (CMC) deliverables according to rigorous scientific and regulatory standards within agreed upon timelines and budgets. This position will provide committed and accountable leadership for the team.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Executes comprehensive, biologic product-specific development strategies and tactics to meet global project needs that incorporates all elements across the intermediates, drug substance, drug product, analytical, quality and regulatory work space
- Oversees manufacturing of biologic candidates for development, clinical trial and marketing authorization programs
- Process and formulation development activities (Protocol generation, batch record and process execution, manufacturing reports)
- Validation activities for processes and analytical procedures
- Stability protocol, stability monitoring and interim and final reporting
- Clear understanding of process and analytical issues, mitigation strategies, technical review of OOS for root-cause analysis and problem solving efforts
- Generation of request for proposal (RFP) for contract manufacturing (CMO) of drug candidates and finalizing the CMOs based on the technical merits in conjunction with cost of manufacturing
- Monitors and reports product-specific plans to ensure project goals are achieved according to the project plan, predefined spending / contractual targets and management expectations
- Executes the project management activities of external contract manufacturing and analytical organizations for the accurate and timely creation and dissemination of project milestones
- Provides technical input and leadership to streamline cost effective and compliant processes and analytics during technology transfer and product manufacturing campaigns
- Ensures appropriate technical, scale-up, and production strategies and timelines are in place to meet clinical supply and registration needs, and ensures production, technology transfer, validation and regulatory outcomes, meet and/or exceeds industry standards
- Responsible for ensuring adequate transition plans to transfer knowledge to clinical and commercial manufacturing
- Communicates effectively and transparently within Biopharmaceutical Development and other stakeholders such as Quality, Regulatory, Clinical and Scientific Affairs across the company
- Develops Project Plans and timelines, manages and tracks installation tasks and milestones
- Writes CMC regulatory portions/ amendments in support of IND, NDA and BLAs. Authors and manages the generation of all development reports (technology transfer, process development, analytical test methods, qualification and validation reports, interim and final stability reports Some travel required (approximately 20%).
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Minimum of 15 years experience in biopharmaceutical development with MS or PhD in chemistry, chemical engineering, biology or related discipline or a BS with equivalent experience 10-15 years in a leader ship roll in biologics manufacture.
- 10-15 years of biopharmaceutical experience required in at least 2 of the following areas of product development and manufacturing.
- Development experience (process and analytical development) in biologics; vaccine experience preferred )
- Manufacturing of clinical trial materials and/ or commercial biologic products
- Manufacturing experience in sterile injectables
- Comprehensive understanding of drug product development and how biopharmaceutical development activities integrate with contract manufacturers and partner with key functional areas such as Quality, Regulatory, Clinical and Scientific Affairs across the company.
- Demonstrated experience in implementing processes and systems
- Experience in managing/overseeing CMO
- Demonstrated expertise in process and analytical development, validation studies and technology transfer of manufacturing processes and analytical methods.
- Experience in being the primary writer for key regulatory submissions including IND, and BLAs (or NDAs).
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
OTHER SKILLS AND ABILITIES:
- Demonstrated experience managing multiple projects simultaneously with aggressive timelines
- Experience and demonstrated ability to manage at a high level of productivity with minimal infrastructure
- Experience in budget planning, management and reconciliation
- Proficient knowledge of Excel, PowerPoint, Microsoft Project
- Experience in outsourcing management and oversight
- Ability to function well in a cohesive management team environment, with strong goal and results orientation
- Proven verbal and demonstrable written communication skills