Process Scientist; Associate Director - Global Manufacturing Science GMSci DP​/PKG

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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.

• Lead the following activities, along with Pharmaceutical Sciences and/or Operation Units:

  • Technology Transfer to both CMOs and Takeda sites.

  • 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.

• Accountable for successful collaboration with:

  • Pharmaceutical Sciences.

  • Manufacturing Sciences

  • Global Manufacturing Supply, Global Quality and Global Regulatory Affairs.

• SME for Takeda drug product manufacturing organization and network.

• In depth and broad understanding of drug product manufacturing technologies for solid oral dosage form and/or injectable products

• Knowledge of industry’s best practices and innovative/emerging technologies for DP manufacturing.

• Effectively communicate and implement innovative and emerging DP technologies.

• Able to communicate and influence decisions of Pharmaceutical Sciences to ensure successful commercialization of Takeda products.

• Able to independently make complex and key decisions impacting drug product manufacturing organization.

• Actively partner with local Manufacturing Sciences to ensure consistent application of best technology practices across Takeda network.

• Ensure process knowledge sharing across sites and functions for effective management of products.

• Manages with a matrix of reporting lines and across functional areas

• Provides leadership to drive highly complex projects including those that span multiple sites and products.

• BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline with 15+ years of industrial experience or equivalent.

• 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 provide superior results.

• Ability to elevate both business and personal capabilities as technologies change.

• Comfort with multi-modality complexity and ability to collaboratively solve problems with minimal initial process knowledge (i.e., in rapid response situation or new technology evaluation and implementation).

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The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education…