Full-Time

CMC Lead

Launch Product, Small Molecules

Posted on 5/9/2026

Takeda

Takeda

10,001+ employees

Global biopharmaceutical firm; R&D-driven NMEs

No salary listed

Bengaluru, Karnataka, India + 1 more

More locations: Dublin, Ireland

In Person

Category
Biology & Biotech (1)
Required Skills
REST APIs
Data Analysis
Requirements
  • A bachelor degree in engineering or life sciences.
  • Minimum 10 to 15 years experience in pharmaceutical development and manufacturing.
Responsibilities
  • Lead the cross functional GSQ CMC team to support effective product development activities with Pharmaceutical Sciences Organization.
  • Lead the GSQ CMC team to develop a robust life cycle management for Takeda’s key small molecule assets.
  • Represent CMC matters within Takeda’s Global Product Teams.
  • Provide strong leadership for initiatives which are complex or span across multiple products.
  • Accountable for the scientific/CMC contents related to a SM asset, take into consideration of business impact to the GSQ organization.
  • Ability to lead the Small Molecules CMC team to effectively resolve issues relating to CMC matter, also at times with the Pharmaceutical Sciences organization, when needed.
  • Ability to work across all GSQ functions, including internal and external manufacturing sites, and Pharmaceutical Sciences to define directions relating for robustness technology excellence and innovation including digital solutions and data analytics.
  • Accountable for key CMC decisions and provide recommendations to have a direct impact on program’s outcome.
  • Has a deep and broad understanding of small molecule product development, manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen.
  • Ability to influence broadly within GSQ organization and Takeda Product Teams to drive decisions, alignment, and conflict resolution for complex cross-functional CMC and technology excellence issues.
  • Work closely with the PMs to drive to the success of the CMC team.
  • Full accountability for complex decisions regarding the development of the SM asset.
  • Accountable for the decision relating to Life Cycle Management activities, and able to effectively manage SMEs from all functional areas to execute the decisions made.
  • Works alongside Pharmaceutical Sciences organization and influence and be accountable for decisions made having impact to the commercialization of the key asset.
  • Works across MSAT small molecule organization (including API and DP) to align CMC Development and LCM activities within the various GSQ functional organizations
  • Works across MSAT global functions as needed for business metrics and align on LCM procedures.
  • Works across MSAT small molecule (API and DP), Pharmaceutical Sciences, and Site Manufacturing Sciences groups to align on vision and priorities for LCM activities.
  • Works with the MSAT CMC LCM group on coordination of hand-off of late stage products to the commercial team.
Desired Qualifications
  • Experience operating globally in a matrixed organization highly preferred.
  • Experience defining the strategy and roadmap for complex, cross-functional initiatives.
  • 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.
  • Capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
  • Scope includes innovation in manufacturing equipment, manufacturing processes, and use of digital technology to provide data-driven approaches.

Takeda is a global biopharmaceutical company focused on discovering and delivering medicines and vaccines to improve patient health. It relies on extensive research and development to create new molecular entities (NMEs) and bring them to market, aiming for up to 15 product launches through FY2024 from a pipeline of 11 NMEs. Revenue comes mainly from selling pharmaceutical products, supported by about 41,000 third-party suppliers worldwide. The company differentiates itself through a deep history (over 240 years), a broad portfolio of global brands, and a patient-centric approach that places patients’ needs at the center of its operations while pursuing environmental sustainability. Takeda’s goal is to advance health globally by turning scientific innovations into accessible therapies, maintaining long-term growth through steady product innovation and responsible operations.

Company Size

10,001+

Company Stage

IPO

Headquarters

Tokyo, Japan

Founded

1781

Simplify Jobs

Simplify's Take

What believers are saying

  • Zasocitinib NDA submission planned FY2026 challenges Bristol Myers Squibb's Sotyktu.
  • Rusfertide PDUFA target Q3 2026 under FDA Priority Review boosts polycythemia vera pipeline.
  • Stock undervalued at ¥5,173 versus ¥6,036 fair value with post-FY2025 revenue recovery.

What critics are saying

  • VYVANSE generic erosion crushes revenue beyond FY2025 stabilization.
  • 634 US layoffs from July 2026 trigger talent exodus to Vertex.
  • JPY 150B FY2026 restructuring costs overrun delays oveporexton launch.

What makes Takeda unique

  • Takeda advances zasocitinib oral TYK2 inhibitor with positive Phase 3 LATITUDE data.
  • Takeda secures exclusive global rights to rusfertide after Protagonist opt-out.
  • Takeda restructures for $1.25B savings by FY2028 to fund multiple launches.

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401(k) Retirement Plan

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6 month growth

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BioSpace
Apr 6th, 2026
Takeda breaks up with Denali, dumps dementia drug.

Takeda breaks up with Denali, dumps dementia drug. April 6, 2026 | Takeda and Denali Therapeutics first partnered in early 2018 to advance drugs for neurodegenerative diseases. One asset, for Alzheimer's disease, was previously discontinued after an FDA hold and disappointing early data. More than eight years after linking up, Takeda and Denali Therapeutics are going their separate ways, with the Japanese pharma handing all rights to a dementia program back to Denali. Takeda's decision to terminate its partnership with Denali "was driven by strategic considerations," the California biotech said in an SEC document dated April 3, and "is not related to efficacy or safety data." The Japanese pharma informed Denali of its decision that same day, according to the securities filing. The companies inked their partnership in January 2018, with Takeda fronting $150 million and promising unspecified milestone payments. Takeda and Denali had also previously been working on the TREM2 agonist DNL919 for Alzheimer's disease - but this molecule's development path has been bumpy. In January 2022, the FDA slapped a clinical hold on the asset, though the partners at the time did not disclose why. The hold was eventually lifted, but Takeda and Denali in August 2023 nevertheless discontinued DNL919's development, pointing to Phase 1 findings suggesting the drug had only a "narrow therapeutic window." In 2021, Takeda also exercised its option to co-develop and co-commercialize DNL593, a protein replacement therapy that can cross the blood-brain barrier, for frontotemporal dementia. That asset has since been returned to Denali, the biotech said on April 3. "We are looking forward to advancing DNL593 independently," CEO Ryan Watts said in a press statement that day, adding that the company "remain[s] confident" in the scientific rationale behind DNL593. DNL593 works by replacing the progranulin protein, which in frontotemporal dementia is deficient, leading to lysosomal defects that, in turn, result in the accumulation of toxins across different tissues. The asset is currently in a Phase 1/2 study, enrollment for which has completed with 40 recruited participants, according to Denali's April 3 release. There have been no reported safety signals to date, the biotech noted. Phase 1/2 data for DNL593 are expected before the end of this year, Watts said. Takeda's pullback comes just days after Denali delivered a much-needed win for the rare disease space with the FDA approval of its Hunter syndrome therapy Avlayah. Like DNL593, Avlayah works by replacing a deficient player, this time targeting the IDS enzyme, which under healthy conditions clears toxic byproducts from several organs, including the brain. Avlayah is the first Hunter syndrome therapy in nearly 20 years and is the first FDA-approved treatment to exploit the transferrin pathway to cross the blood-brain barrier. Avlayah is the first Hunter syndrome therapy approved to address the condition's neurologic complications, according to Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research. March 26, 2026

The Boston Globe
Mar 31st, 2026
Pharma giant Takeda to lay off nearly 250 local workers in latest job cutting.

Pharma giant Takeda to lay off nearly 250 local workers in latest job cutting. By Marin Wolf Globe Staff, Updated March 30, 2026, 10:00 a.m. Takeda Pharmaceuticals will lay off nearly 250 workers in Cambridge, the state's largest biopharma employer announced through a state filing. The layoffs will begin in July, although some will take place later in the year or in 2027. All affected Massachusetts employees work at the company's 500 Kendall St. location, according to the filing posted Friday. The workforce reduction is part of a cost-saving plan approved by Takeda's board of directors on March 25 that is expected to result in annual savings of about $1.25 billion by 2028, according to a company statement. Another 387 workers in other states may also be laid off as part of the plan.

Yahoo Finance
Mar 30th, 2026
Takeda Pharmaceuticals to cut 247 jobs in Cambridge as part of $1.2B cost-cutting plan

Takeda Pharmaceuticals, Massachusetts' largest biopharmaceutical employer, will lay off 247 employees at its Cambridge headquarters as part of a broader corporate restructuring. The redundancies begin on 1 July and could extend into 2027. The Japanese company announced cost-cutting measures expected to save approximately $1.2 billion by 2028. An additional 387 employees will be laid off in other US states. Affected workers are receiving transition assistance, including help identifying internal opportunities. Takeda currently has around 700 open positions, including 300 in Massachusetts, with internal candidates given priority. The company employs more than 5,700 people in Massachusetts and occupies approximately 2.8 million square feet of real estate. This follows 137 layoffs announced in October and over 800 Massachusetts redundancies in 2024.

BioSpace
Mar 30th, 2026
Takeda restructuring could push more than 600 US staffers out of jobs.

Takeda restructuring could push more than 600 US staffers out of jobs. March 30, 2026 | Takeda's layoffs include cutting 247 people in Massachusetts. The workforce reduction is meant to help offset investments in areas including a product launch for oral drug candidate zasocitinib, for which the pharma today announced positive Phase 3 data. The workforce impact of Takeda's recently announced reorganization has become clearer. The Japan-based pharma estimates the restructuring will affect around 634 U.S. employees, according to a Worker Adjustment and Retraining Notification (WARN) Act notice. Takeda began notifying employees on March 25, the same day it announced a business transformation, which includes streamlining corporate functions. However, the company noted in the WARN notice that the total number affected could change as staff pursue and accept redeployment opportunities across its global network. Takeda's cuts include 247 employees in Cambridge, Massachusetts, effective July 1, 2026, through Dec. 31, 2027. To understand where other layoffs will take place, BioSpace has requested a copy of a document mentioned in the WARN notice that lists the number of individuals affected by state. In last week's announcement, Takeda noted that the restructuring, which includes "strategically prioritizing resources," is expected to save more than 200 billion yen - about $1.25 billion - by fiscal year 2028. The company explained that the savings will offset investments needed to prepare for multiple launches, including oveporexton, usfertide and zasocitinib; progress the late-stage pipeline; and support strategic technology investments. Takeda announced today promising data for zasocitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate to severe plaque psoriasis. In the Phase 3 Latitude PsO 3001 and 3002 studies, more than half of patients treated with the drug candidate achieved clear or almost clear skin at week 16, a key measure of treatment success, according to the pharma. Zasocitinib also demonstrated statistically significant improvements in complete skin clearance. Takeda expects to submit a new drug application for zasocitinib in fiscal year 2026. The pharma acquired zasocitinib from Nimbus Therapeutics for $4 billion at the end of 2022 to challenge Bristol Myers Squibb's kinase inhibitor Sotyktu. Takeda in December 2025 reported positive results from the Phase 3 LATITUDE studies, noting that when compared with placebo and Amgen's Otezla, about 30% of treated patients achieved completely clear skin, or a score of 100 on the Psoriasis Area and Severity Index (PASI). The company's latest layoffs join a series of cuts from the past two years. Takeda let go of nearly 1,500 employees in the U.S. and Austria in 2024 and early 2025 and 137 in October 2025. In January, news broke that 243 people would be laid off across its U.S. operations.

Healthcare Asia Magazine
Mar 30th, 2026
Takeda Healthcare Philippines, Inc. wins at Healthcare Asia Pharma Awards 2026.

Takeda Healthcare Philippines, Inc. wins at Healthcare Asia Pharma Awards 2026. The access programme and advocacy initiative closed affordability gaps for Filipino patients. Takeda Healthcare Philippines, Inc. won Most Differentiated Service of the Year - Philippines and Patient Advocacy Program of the Year - Philippines in the Healthcare Asia Pharma Awards 2026 for its access model that supports patients from disease awareness to therapy completion. In a healthcare system where many patients face delayed diagnosis, long referral pathways, and high out-of-pocket costs, the company built a differentiated and sustainable service anchored on its Patient Assistance Program (PAP). The programme follows a clear principle: therapy completion should not depend on a patient's ability to pay. PAP uses an affordability-based assessment to evaluate each eligible patient's circumstances and set a contribution aligned to what the patient can reasonably afford for the full course of treatment. This structured, patient-level approach supports equity whilst maintaining business viability. It is not a standard discount model but a tailored access scheme designed for Filipino patients and adaptable to changing circumstances. The operating model involves independent third parties assessing financial support needs and informing programme design. Patients share in the cost of treatment, whilst Takeda Healthcare Philippines, Inc. collaborates with local authorities and partners to help cover the remaining cost. The company embeds access within hospital pathways through collaborations with organisations such as the Tzu Chi Foundation, private institutions, and major hospitals, helping reduce out-of-pocket expenses and improve coordination across the patient journey. Join Healthcare Asia Magazine community To date, more than 1,300 Filipino patients have received support through Takeda's access programme, including patients living with Hodgkin lymphoma, inflammatory bowel disease, and other rare conditions. By enabling therapy completion, the programme helps patients return to work or school and resume caregiving roles, reducing the broader social and economic burden of untreated disease. Beyond affordability, the company addresses inequity in geographically isolated and disadvantaged areas by working with partners to strengthen patient navigation and connections to appropriate providers and specialists. Through Access to Medicines Summits and partnership frameworks, it also supports patients in accessing available private and government funding. A key milestone in its advocacy efforts is the inclusion of life-saving treatment for rare diseases such as haemophilia in the Philippine National Formulary, enabling free access to essential medicines in government hospitals following partnerships and a positive health technology assessment. The Healthcare Asia Pharma Awards shines a spotlight on the outstanding companies redefining pharmaceutical excellence in Asia. It lauds those who redefine the pharmaceutical landscape through innovative, unique initiatives that have significantly enhanced their businesses. The Healthcare Asia Pharma Awards is presented by Healthcare Asia Magazine. To view the full list of winners, click here. If you want to join the 2027 awards programme and be recognised for your organisation's innovative and unique initiatives that enhanced your business and remarkable contributions to the pharmaceutical industry, please contact Julie Anne Nuñez-Difuntorum at [email protected].