Takeda · 1 week ago
Process Engineer Small Molecules API Process Science (Associate Director)
Takeda is a company focused on providing process engineering support in batch or continuous API platforms. The Associate Director will lead the Global Process Science team, implement continuous improvement strategies, and ensure successful collaboration across various functions to enhance process understanding and controls.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Lead the Global Process Science, Small Molecules API Manufacturing Science team and serve as Takeda’s expert on small molecule API process and technologies
Provide strong leadership for the following activities, along with Pharmaceutical Sciences and/or Operation Units API Manufacturing Process Characterization, Technology Transfer from/to external CMOs and/or internal manufacturing sites. Process validation, Risk assessment, Global expansion, COGs management, Regulatory Activities, Process / Product knowledge
Lead projects within Takeda product portfolio, both development and commercial, to support Small Molecules API Manufacturing Sciences activities
Develop and implements strategies for the continuous improvement on the manufacturing of Marketed Products in the late phase of the product life cycle
Lead the team to implement the manufacturing strategy for key Takeda products at internal manufacturing network and external CMOs
Lead the effort to create systems and procedures for best practice in commercial technology transfer, process validation
Lead the team that serves as the central hub of manufacturing process knowledge and establishes system and procedures to ensure the expertise and process knowledge are shared across global Takeda products and sites
Accountable for successful collaboration with: Other functions such as API in Oncology & External Supply Small Molecules Unit, Network strategy in Strategy & Business Excellence etc
Manufacturing Operating Unit Site leads
Local Technical Services functions
Pharmaceutical Sciences counterparts
Other key functional groups such as Global Quality, Regulatory CMC etc
Provide vision and strategy for manufacturing technology projects
Ability to lead and influence the local Manufacturing Science organization for global manufacturing strategy alignment
Effectively communicate Global Manufacturing Sciences visions across the functions
Understanding of API manufacturing from phase appropriate development stage to commercial scale
Must have sound understanding of Organic Chemistry/Pharmaceutical chemistry
Ability to work within a multi-functional team (i.e., Engineering, Manufacturing Operations, Manufacturing Sciences, CMC team etc.)
Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions in a cross-functional team
Provide SME support for Due Diligence of M&A and other in-licensing activities
Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms
Qualification
Required
MS/PhD in Chemical or Process Engineering or Pharmaceutical Engineering
At least 5+ years' experience in a cGMP environment
Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience
Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
Creating the environment that inspires and enables people
Focusing on the few priorities and provide superior results
Elevating capabilities for now and the future
Preferred
At least 5+ years of pharmaceutical industry experience in small molecules is preferred
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
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
Recent News
2026-01-09
2026-01-08
Company data provided by crunchbase