Head of Parenteral Drug Products (Vice President)

Takeda•Boston, MA

9h•Hybrid

About The Position

OBJECTIVES/PURPOSE: Leads the global Parenteral Drug Product organization and delivery of parenteral drug product development from early phase through commercialization and lifecycle management. Sets strategy and builds capabilities for robust parenteral formulations and aseptic fill/finish processes, including tech transfer and process validation/PPQ readiness. Partners with Device Development (as needed) and key stakeholders (GSQ, Quality, Regulatory CMC, Commercial, R&D, Supply Chain) and external partners to deliver high-quality parenteral and combination products.

Requirements

Deep expertise in parenteral biologics drug product development (liquid and lyophilized), including formulation science, stability, aggregation/particulates control, and analytical/biophysical characterization interface.
Strong knowledge of aseptic processing and fill/finish manufacturing science (sterility assurance, contamination control strategy, process controls, equipment/technology selection).
Demonstrated expertise in lyophilization development (cycle design, scale-up, CPP/CQA linkage, process robustness) and/or other stabilization approaches.
Experience with container closure systems for parenterals (vials, syringes, cartridges) and key technical risk areas (silicone oil, tungsten, delamination, extractables/leachables, compatibility).
Proven track record in global parenteral CMC regulatory strategy and filings, including successful licensure and post-approval changes.
Strong capability leading tech transfer to internal sites and/or CMOs and supporting PPQ, commercial troubleshooting, and lifecycle change execution.
Strategic thinking, facilitative leadership.
Executive leadership presence and confidence.
Enterprise level leadership with the ability to inspire, motivate and drive results.
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.
Ability to assemble and manage a diverse and high performing team.
Demonstrated ability to lead teams across functions, regions and cultures.
Ability to distill complex issues and ideas down to simple comprehensibility.
Proven skills as leader who can engender credibility and confidence within and outside the company.
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
Broad decision-making responsibilities: Ability to make highly complex decisions that impact the enterprise.
Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.
Ability to incorporate feedback and ensure decisions are made transparently and swiftly to yield flawless execution.
Accountable for designing and implementing vision and strategy for designated scope.
Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring an engaging and inclusive workplace.
Ability to effectively implement R&D’s partnership strategy.
Effectively represent Takeda in high-level negotiations with the ability to resolve conflict in a constructive manner.
Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to Pharmaceutical Sciences, GSQ, GPLS, and Regulatory CMC.
Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation.
Comfortable challenging the status quo and bringing forward innovative solutions.
Ability to take risks implementing innovative solutions, accelerating time to market.
Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 25+ years relevant industry experience.
Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 20+ years relevant industry experience.
PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 15+ years relevant industry experience.
Demonstrated people and program management skills, critical and out-of-the-box thinking ability.
Demonstrated ability to anticipate issues and manage a team to proactively implement solutions.
Experience in assuring the implementation of required quality processes and standards to facilitate smooth transition from product development to commercialization.
Demonstrated expertise in writing regulatory documents.
Understands the structure, functions, and methods of the global Takeda organization and overall Takeda R&D and Commercial operations.
Excellent organizational and communication skills.
Has the ability to influence at all levels of the organization and manage projects and initiatives across businesses and the globe.
Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions.
Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.
Demonstrated ability to effectively lead and motivate a team of direct reports, build on strengths, and address areas for improvement.
Proven record of building mutually-respectful relationships across global regions and companies in order to foster communication and achieve strategic goals.

Responsibilities

Owns the global Parenteral Drug Product strategy and capability roadmap across modalities (e.g., mAbs, recombinant proteins, peptides, oligos, complex biologics) to deliver clinically and commercially viable parenteral products.
Accountable for parenteral formulation development (liquid and lyophilized) including stability, compatibility, excipient selection, and robust control strategies aligned to target product profile and patient use.
Leads development of aseptic fill/finish processes and scale-up, including sterile filtration, filling technologies, lyophilization cycle development, and container closure strategy through PPQ and commercialization.
Ensures integration with Device Development for combination products and delivery systems (e.g., PFS, autoinjectors, pens) including drug-product/device compatibility and performance requirements.
Owns parenteral CMC deliverables for global submissions (IND/CTA/BLA/NDA/MAA and variations), ensuring high-quality module content, agency interactions, and inspection readiness.
Drives lifecycle management for commercial parenteral products: deviation investigations support, CAPA contributions, change control, process robustness, cost-of-goods improvements, and supply continuity in partnership with GSQ and manufacturing sites/CMOs.
Establishes platform approaches for parenteral development (e.g., platform formulations, standard CCS options, leachables/extractables strategy alignment, standard lyophilization approaches) to accelerate pipeline delivery.
Leads external network strategy for parenteral DP (CDMOs/CMOs, component suppliers), including technical governance, performance metrics, and risk mitigation.
Builds and develops a high-performing global organization; defines operating mechanisms, talent strategy, and resourcing across programs and geographies.

Benefits

U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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