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About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Digital Drug Product Development Associate Scientist where you will be responsible for development of Takeda's parenteral products (including mAbs, recombinant proteins, peptides, and ADCs). Responsibilities include development of robust formulation for drug substance and drug product throughout their product lifecycle and development/tech transfer of scalable and robust drug product manufacturing process from early phase to process validation. You will provide technical guidance for formulation and drug product development efforts, author technical protocols, design and implement experimentation, generate technical reports, and author related CMC sections to support regulatory submissions. You will also need some background in Computer Science to be involved in the data modeling, design, building, and/or deployment of in-silico/simulations/digital initiatives/digital twins. Furthermore, it is expected to apply modern computational techniques to the traditional pharmaceutical formulation concepts such as the application of machine learning and data analytics to formulation development process.

You will work closely with the existing Digital Scientists Community in further developing our capabilities for in-silico/simulations/digital initiatives/digital twins.

You will collaborate with cross-functional Process Development and CMC team members including technical services, drug substance process development, analytical development, quality control, quality assurance, and supplier relationship and manufacturing leads. You will also interface with external contract organizations as required.

How you will contribute:

• Provide technical expertise in execution of biologics product formulation development

• Provide technical expertise for clinical drug product process development/engineering and clinical drug product manufacturing support

• Author/review development documents and support regulatory submissions and responses

• Provide technical expertise in modern computational techniques

• Provide expertise and proven record of deployment of in silico/simulations/digital initiatives/digital twins

• Provide applied data science and predictive analysis and modeling support (e. g. , AI/ML, statistical, chemometric) to multiple projects or project teams

• Represent drug product development within cross functional project teams, organizational initiatives, and technology development groups

• Design and execute phase-appropriate DP formulation development, process development, process characterization, and process validation studies

• Support drug product manufacturing deviation investigations, CAPAs, and change control management

• Help develop project strategy and communicate complex data/decisions within department and cross functionally as necessary

Minimum Requirements/Qualifications:

• Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science with heavy emphasis on Computer Sciences, Data Science, Bio-Informatics, and 5+ years relevant industry experience

• Master's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science, with heavy emphasis on Computer Sciences, Data Science, Bio-Informatics, and 3+ years relevant industry experience

• Bachelors or Masters: Experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's

• Familiarity with current Good Manufacturing Practices (cGMP)

• Previous experience with the use of contract facilities

• Experience working in a multi-disciplinary team environment

• Experience/familiarity with data modeling, simulation, in-silico are needed

• Experienced and a demonstrated track record in biopharmaceutical development including but not limited to drug product development, drug product process characterization, QbD, control strategy, and validation

• Good understanding of protein degradation background and stabilization strategies applicable to common dosage forms

• Good understanding of CMC management with involved function areas to drive and meet deliverables in the matrix environment and cross-functional improvements

• Experience/familiarity in analytical and biophysical methods is a plus.

• Preferably, experienced in lyophilization and/or combination drug product development with an understanding of the inter-relationship among formulation parameters, process parameters, device performance, product delivery, and quality.

• Excellent communication, technical, organizational, interpersonal and leadership skills are required

• Must be a team player prepared to lead, work effectively and efficiently in a team-based environment

• Critical evaluation of results and ability to defend strategic guidance to resolve technical issues

• Must be able to perform experiments in the laboratory

• (4+ days) on site. May require 5-10% travel

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around .