Head of Manufacturing
This company is seeking to attract a key member of its leadership team to be the Vice President, Manufacturing, with the mandate to provide the vision, leadership, strategy and management skills to oversee, lead and further expand the manufacturing of company’s proprietary programs through preclinical, clinical and commercial stages. In particular, the VP of Manufacturing will have oversight over the company’s entire out-sourced manufacturing effort, the company’s Programs progress.
The Vice President, Manufacturing is responsible for translating the corporate strategy into supportive strategies for global pharmaceutical manufacturing, packaging, supply chain, logistics and quality control (including process development, analytical development, technology transfer, validation, etc.) from early-mid stage product development through global manufacturing for commercial products. S/he oversees and provides technical leadership, strategic direction, risk assessment, and oversight for successful long-range planning and execution across all supporting functions
S/he leads assessments and analyses resulting in recommendations for contract manufacturing organization (CMO) qualification and negotiations that are consistent with and supportive of the global strategic plan and translation of strategy into an executable series of pharmaceutical manufacturing plans and quality control systems to ensure deliverables meet approved budgets, timelines and adhere to all international and national laws, guidelines and required quality control standards. The position has ultimate responsibility for the company’s strategy and oversight of supply chain/manufacturing and management of all technical operations activities to deliver products to clinical trials and/or market within defined regulatory, legal, quality and cost standards.
The ideal candidate will be a seasoned pharma/biotech executive with an outstanding record of accomplishment in R&D manufacturing of biologics, quality, supply chain management and logistics and with experience in the global submission and maintenance of CMC sections of regulatory (BLA) filings. Candidates will have previously worked on biologics CMC development programs that have been filed and approved for registration with the FDA and other global regulatory bodies.
This is an outstanding opportunity to serve as a driving force in building and expanding the company pharmaceutical development and manufacturing organizations, and one that will provide broad business leadership challenge, accountability and impact for the successful candidate.
The Vice President, Manufacturing will be responsible for leading, managing and coordinating the full breadth of all outsourced manufacturing operations activities for the company’s portfolio in collaboration with the research, development, and business teams. In addition, the successful candidate will play a key role in developing and implementing integrated CMC regulatory strategies for the company pipeline projects.
S/he will be responsible for assuring a reliable preclinical, clinical and future supply of safe, high-quality drug products and will lead the manufacturing strategies and address capacity issues. This position will be responsible for directing and managing the company’s external contract research and manufacturing operations and ensure appropriate processes are in place to support clinical manufacturing.
S/he provides a nexus for communication from the executive level to relevant technical leaders and between technical leaders and works closely with technical leaders to translate strategic plans and evolving company goals into actionable tactical plans, set priorities, measure results, assess and implement new learnings for continual improvement, and report progress to the executive staff and the CEO. It is the responsibility of the Vice President, Manufacturing to develop approaches acceptable to the CEO and Board to communicate risks, recommended mitigation strategies, and project status to stakeholders, including the Board, and to obtain buy-in for relevant recommendations from managers and directors.
Oversight and Accountability
The Vice President, Manufacturing oversees, manages, and provides development opportunities for and technical leaders in all areas of pharmaceutical development, manufacturing, planning, procurement, logistics, production control, and quality control functional managers, accountable for implementing the executive strategy by clearly defining deliverables in the context of the corporate plan for each functional area and then measuring the results against the goals. This includes listening to and gathering any concerns, finding common ground solutions, highlighting necessary changes, and then collaborating with the executive committee to endorse changes in the strategic plan, where necessary.
The Vice President, Manufacturing works with technical leaders to develop policies, processes and programs that ensure efficient workflow and the production of high-quality drug product and associated documentation. S/he ensures development processes comply with regulatory requirements to minimize risk to the organization, and addresses the analysis and evaluation of process development procedures and practices to ensure compliance with regulatory, legal and good manufacturing procedures to attain corporate goals.
Areas of specific key responsibility will include:
Build, lead, manage and develop a best-in-class, high-performance team and related support functions. Provide effective leadership to the organization to ensure the development of the business and its people. Manage the organization to accommodate anticipated growth and to ensure bench strength across all levels. Ensure technical leadership and all departmental associates have development opportunities and plans for career advancement, are provided with routine and useful feedback, have personal goals aligned with corporate, program team, and brand goals and a clear understanding of how their work directly impacts patients and is relevant to the success of AnaptysBio.
As a part of the management team, participate in strategic and operational decisions regarding several aspects of growth for the company.
Ensure appropriate technical oversight of external CMOs and internal resources to ensure effective production to supply clinical studies in compliance with Global Health Authority Regulations as well as regional requirements and ICH Guidelines.
Oversee functional efforts to optimize existing processes, scale-up efforts and solve complex manufacturing issues in a compliant and timely manner.
Be responsible for assessing and analyzing information resulting in recommendations for long-term manufacturing solutions, including new manufacturing sites and facilities, that are aligned with the corporate strategy and evolving goals.
Support product launches by ensuring practical and cost-effective manufacturing and analytical approaches.
Routinely assess and define risks associated with in the span of control, create and implement effective mitigation plans, and escalate as appropriate.
Ensure the management of all financial aspects of the supply chain including budgeting, forecasting, long-range planning and overall management and accountability of product supply. Help lead development of the company’s supply chain strategy, the annual global business goals and tactical implementation plans in collaboration with the other members of the management team, including effective involvement of direct reports and communication with colleagues.
Work collaboratively with regulatory affairs colleagues to help manage, direct and monitor the preparation, assembly and filing of CMC regulatory submissions to support new product approvals and existing brands, including interactions between the company and health authority representatives to facilitate IND, BLA and other submissions. Directly accountable at the executive level for the accuracy and quality of all associated documentation, including submissions and query responses provided to regulatory authorities. Ensure compliance with respect to CMC requirements to assure favorable compliance reviews and audits.
Ensure the organization’s resources are aligned and prepared to support the development, launch, and clinical manufacturing needs for quality production
Regular interaction with R&D, CMO and CMC support teams for continual process improvements
Work collaboratively with Quality and Regulatory to oversee establishment of development stage and product appropriate specifications aligned with production capabilities.
Lead development of relationships and contracts for the procurement of high value and cost- effective services and materials for the company's products. Coordinate the selection and oversight of component vendors and contract manufacturers. Conduct project management and day-to-day interactions with all related research and contract manufacturing operations for clinical products.
Ensure all manufacturing agreements are effectively negotiated to meet the near and long term needs of the company in a cost-efficient manner as agreed with legal, finance and functional heads.
Review technical documentation and summaries to ensure sound rationale, conformance with regulations and existing approvals, and challenge where appropriate the effectiveness of these documents to deliver on the intended purpose.
Develop plans to accomplish company objectives and achieve long-range and short-term product development objectives.
Develop departmental budget and product cost structure, and identify profit improvement opportunities. Have full budget responsibility and accountability. Review and approve expense and capital budgets for non-clinical development and manufacturing.
Hold all department members accountable for establishing the minimal number of processes that enable the most efficient workflow and product in keeping with all relevant International and regional standards and guidelines.
Develop and generate strategy and then implement a global supply chain and inventory risk management procedures.
Manage process for product charge backs, returns, recalls and customer service.
Understand the company’s current performance levels; define, implement and manage Key Performance Indicators (KPI) both internally and for third party relationships to produce results that are cost-effective, mitigate risk and ultimately have a positive effect on daily operations that add value for the company.
Determine and enforce productivity, quality and safety requirements in accordance with company needs, based on current regulations and state-of-the-art product development.
Provide business updates to executive management including the tracking and communication of results compared to key performance metrics/targets. Develop and monitor performance against marketing and supply forecasts and plans, ensuring the achievement of results is within designated budgets. Recommend and implement adjustments to strategies and tactics as needed.
As required, present the company’s CMC plans to regulators, potential partners, and collaborators.
Assist in the evaluation of opportunities in the marketplace that will enhance the growth of the business and help assess business development activities.
Help represent the company in the context of conferences, presentations, and industry groups.
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