BioSpace
Process Scientist (Associate Director) - Global Manufacturing Science GMSci DP/
BioSpace, Boston, Massachusetts, us, 02298
Process Scientist (Associate Director) - Global Manufacturing Science GMSci DP/PKG
Location: Cambridge, MA
Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG
About The Role As a Process Scientist (Associate Director) - Global Manufacturing Science GMSci Drug Product (DP), you will provide technical expertise within the GMSci DP organization relating to manufacturing technology and sciences for our multi‑modal biologics, small molecule and plasma DP manufacturing. You will act as the Subject Matter Expert (SME) for significant technical transfers and validation projects associated with new product introductions and the life‑cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (CMC) content for dossiers. Additionally, you will ensure that process knowledge is effectively shared and utilized across various sites, serving as Takeda’s global DP SME for resolving issues.
How Will You Contribute
Lead technology transfer to CMOs and Takeda sites.
Lead drug product manufacturing process validation.
Serve as the expert for rapid response teams.
Manage projects within Takeda product portfolio, both development and commercial, to support Manufacturing Sciences DP activities, including high‑impact life‑cycle management projects.
Collaborate with Pharmaceutical Sciences, Manufacturing Sciences, Global Manufacturing Supply, Global Quality and Global Regulatory Affairs.
Act as SME for Takeda drug product manufacturing organization and network.
Possess in‑depth and broad understanding of drug product manufacturing technologies for solid oral dosage form and/or injectable products.
Apply industry best practices and innovative/emerging technologies for DP manufacturing.
Communicate and implement innovative and emerging DP technologies across sites.
Influence decisions of Pharmaceutical Sciences to ensure successful commercialization of Takeda products.
Make complex decisions impacting drug product manufacturing organization.
Partner with local Manufacturing Sciences to ensure consistent application of best technology practices across the Takeda network.
Ensure process knowledge sharing across sites and functions for effective product management.
Manage multiple reporting lines and functional areas.
Provide leadership to drive highly complex projects spanning multiple sites and products.
What You Bring To Takeda
BS or graduate degree in Chemistry, Chemical Engineering, or related discipline with 15+ years of industrial experience.
Minimum 10 years’ experience in pharmaceutical development and/or manufacturing.
Previous experience as an SME lead in a DP manufacturing matrix environment.
Ability to prioritize and deliver superior results.
Ability to elevate business and personal capabilities as technologies evolve.
Comfort with multi‑modality complexity and ability to collaboratively solve problems with minimal initial process knowledge, e.g., rapid response situations or new technology evaluation and implementation.
Takeda Compensation and Benefits Summary U.S. Base Salary Range (Boston, MA): $153,600.00 – $241,340.00.
Eligible for short‑term and long‑term incentives. Benefits include medical, dental, vision insurance; a 401(k) plan with company match; short‑term and long‑term disability coverage; basic life insurance; tuition reimbursement; paid volunteer time off; company holidays; and well‑being benefits. Eligible to accrue up to 120 hours of paid vacation and up to 80 hours of sick time per calendar year.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG
About The Role As a Process Scientist (Associate Director) - Global Manufacturing Science GMSci Drug Product (DP), you will provide technical expertise within the GMSci DP organization relating to manufacturing technology and sciences for our multi‑modal biologics, small molecule and plasma DP manufacturing. You will act as the Subject Matter Expert (SME) for significant technical transfers and validation projects associated with new product introductions and the life‑cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (CMC) content for dossiers. Additionally, you will ensure that process knowledge is effectively shared and utilized across various sites, serving as Takeda’s global DP SME for resolving issues.
How Will You Contribute
Lead technology transfer to CMOs and Takeda sites.
Lead drug product manufacturing process validation.
Serve as the expert for rapid response teams.
Manage projects within Takeda product portfolio, both development and commercial, to support Manufacturing Sciences DP activities, including high‑impact life‑cycle management projects.
Collaborate with Pharmaceutical Sciences, Manufacturing Sciences, Global Manufacturing Supply, Global Quality and Global Regulatory Affairs.
Act as SME for Takeda drug product manufacturing organization and network.
Possess in‑depth and broad understanding of drug product manufacturing technologies for solid oral dosage form and/or injectable products.
Apply industry best practices and innovative/emerging technologies for DP manufacturing.
Communicate and implement innovative and emerging DP technologies across sites.
Influence decisions of Pharmaceutical Sciences to ensure successful commercialization of Takeda products.
Make complex decisions impacting drug product manufacturing organization.
Partner with local Manufacturing Sciences to ensure consistent application of best technology practices across the Takeda network.
Ensure process knowledge sharing across sites and functions for effective product management.
Manage multiple reporting lines and functional areas.
Provide leadership to drive highly complex projects spanning multiple sites and products.
What You Bring To Takeda
BS or graduate degree in Chemistry, Chemical Engineering, or related discipline with 15+ years of industrial experience.
Minimum 10 years’ experience in pharmaceutical development and/or manufacturing.
Previous experience as an SME lead in a DP manufacturing matrix environment.
Ability to prioritize and deliver superior results.
Ability to elevate business and personal capabilities as technologies evolve.
Comfort with multi‑modality complexity and ability to collaboratively solve problems with minimal initial process knowledge, e.g., rapid response situations or new technology evaluation and implementation.
Takeda Compensation and Benefits Summary U.S. Base Salary Range (Boston, MA): $153,600.00 – $241,340.00.
Eligible for short‑term and long‑term incentives. Benefits include medical, dental, vision insurance; a 401(k) plan with company match; short‑term and long‑term disability coverage; basic life insurance; tuition reimbursement; paid volunteer time off; company holidays; and well‑being benefits. Eligible to accrue up to 120 hours of paid vacation and up to 80 hours of sick time per calendar year.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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