Associate Director-Process Engineer SM API Process Sci jobs in United States
cer-icon
Apply on Employer Site
company-logo

Takeda · 3 months ago

Associate Director-Process Engineer SM API Process Sci

Takeda is a leading global biopharmaceutical company committed to improving the health of patients worldwide. The Associate Director-Process Engineer SM API Process Sci will provide process engineering support in batch or continuous API platforms, integrating mechanistic modeling and process simulation to enhance process understanding and controls. This role involves leading projects, implementing continuous improvement strategies, and collaborating with cross-functional teams to support small molecules API manufacturing sciences activities.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Leads the GMSci, Global Process Science, Small Molecules API Manufacturing Science organization ; may serves as Takeda’s expert on small molecule API process and technologies
Provides 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
Leads projects within Takeda product portfolio, both development and commercial, to support Small Molecules API Manufacturing Sciences activities
Develops and implements strategies for the continuous improvement on the manufacturing of Marketed Products in the late phase of the product life cycle
Leads the team to implement the manufacturing strategy for key Takeda products at internal manufacturing network and external CMOs
Leads the effort to create systems and procedures for best practice in commercial technology transfer, process validation
Leads 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 within GMS such as API in Onco&ES SM OpU, 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 MSci 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

Process EngineeringAPI ManufacturingChemical EngineeringProcess ValidationRisk AssessmentLeadershipInterpersonal SkillsProblem SolvingTeam CollaborationStrategic Thinking

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

twittertwittertwitter
company-logo
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 Company
Total Funding
$2.46B
2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M

Leadership Team

leader-logo
Christophe Weber
President and CEO
linkedin
leader-logo
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
linkedin
Company data provided by crunchbase