Takeda · 1 day ago
Associate Director, API Process Engineering
Brooklyn Park, MN
Full-time
Hybrid
Lead/Staff, Director/Executive
5+ years expTakeda is a company focused on transforming patient care through innovative pharmaceuticals. The Associate Director, API Process Engineering will serve as a global expert in small-molecule API manufacturing processes, applying chemical engineering principles to enhance process understanding and support regulatory submissions.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Lead the Small Molecules API Manufacturing Sciences activities within Global Process Science, serving as expert for small-molecule API processes and technologies
Provide process engineering support for batch and continuous API platforms from clinical through commercial stages, integrating process chemistry and engineering perspectives
Apply mechanistic modelling, process simulation, and quantitative analysis to enhance process understanding and enable robust process control
Lead API manufacturing process characterization, including risk assessments and definition of critical process parameters and controls
Lead technology transfer of API processes between internal sites and external CMOs, ensuring robust, reproducible, and compliant implementation
Lead API process validation activities, including strategy, protocol design, execution support, and data evaluation
Develop and implement strategies for continuous improvement of marketed API processes, including yield optimization, robustness improvements, cost of goods (COGs) reduction, and capacity expansion
Establish and maintain systems and procedures for best practice in commercial technology transfer and process validation
Build and oversee a central knowledge base of API process and product understanding, ensuring lessons learned are shared across products, sites, and functions
Collaborate closely with GMS functions (e.g., Small Molecules Operations Units, network strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC
Provide technical support to marketing applications for global markets and lead preparation of responses to regulatory questions from health authorities
Utilize structured root cause analysis techniques to investigate process and equipment issues and deliver robust, sustainable corrective and preventive actions
Provide subject matter expertise for due diligence in mergers and acquisitions and in-licensing evaluations
Qualification
Required
At least a Master's degree in an area related to Chemical Engineering, Process Engineering, or Pharmaceutical Engineering
At least 5 years of experience in a cGMP manufacturing environment and at least 5 years of pharmaceutical industry experience in small-molecule APIs (these may overlap)
Strong foundation in organic/pharmaceutical chemistry and chemical engineering, with applied experience in API manufacturing processes
In-depth understanding of pharmaceutical manufacturing processes, ICH guidelines, and current global regulatory requirements relevant to API processes
Demonstrated experience in mechanistic modelling, process simulation, and data-driven process optimization
Proven track record leading API process characterization, technology transfer, process validation, and lifecycle changes in a multi-site or global context
Strong problem-solving, project management, and stakeholder management skills, including the ability to resolve conflicts and drive clear decisions in cross-functional teams
Excellent written and verbal communication skills, including experience preparing high-quality technical reports and presenting project results to diverse audiences
Ability to work independently and proactively while collaborating effectively within multi-disciplinary teams (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC teams, and others)
Commitment to sharing knowledge across functions and sites and to building sustainable technical capabilities in the organization
Intellectual curiosity about technology and new ways of working, coupled with a collaborative and open mindset
Willingness to travel to our international manufacturing sites and work side-by-side with site teams on highly complex issues
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase