Digital Drug Product Development Associate Scientist - Innovation in Pharmaceutical Technology (Apply in minutes)

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• Job Description
• About the role : At Takeda, we are a forward-looking, world-class R&D; organization thatunlocks innovation and delivers transformative therapies to patients. Byfocusing R&D; efforts on four therapeutic areas and other targetedinvestments, we push the boundaries of what is possible in order to bringlife-changing therapies to patients worldwide.Join Takeda as a Digital Drug Product Development Associate Scientist whereyou will be responsible for development of Takeda’s parenteral products(including mAbs, recombinant proteins, peptides, and ADCs). Responsibilitiesinclude development of robust formulation for drug substance and drug productthroughout their product lifecycle and developmenttech transfer of scalableand robust drug product manufacturing process from early phase to processvalidation. You will provide technical guidance for formulation and drugproduct development efforts, author technical protocols, design and implementexperimentation, generate technical reports, and author related CMC sectionsto support regulatory submissions. You will also need some background inComputer Science to be involved in the data modeling, design, building, andordeployment of in-silicosimulationsdigital initiativesdigital twins.Furthermore, it is expected to apply modern computational techniques to thetraditional pharmaceutical formulation concepts such as the application ofmachine learning and data analytics to formulation development process.You will work closely with the existing Digital Scientists Community infurther developing our capabilities for in-silicosimulationsdigitalinitiativesdigital twins.You will collaborate with cross-functional Process Development and CMC teammembers including technical services, drug substance process development,analytical development, quality control, quality assurance, and supplierrelationship and manufacturing leads. You will also interface with externalcontract 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 developmentengineering and clinical drug product manufacturing support
• Authorreview development documents and support regulatory submissions and responses
• Provide technical expertise in modern computational techniques
• Provide expertise and proven record of deployment of in silicosimulationsdigital initiativesdigital twins
• Provide applied data science and predictive analysis and modeling support (e.g., AIML, 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 datadecisions within department and cross functionally as necessary# Minimum RequirementsQualifications :
• 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
• Experiencefamiliarity 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
• Experiencefamiliarity in analytical and biophysical methods is a plus.
• Preferably, experienced in lyophilization andor 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 novelspecialty pharmaceuticals and best in class patient support programs. Takedais a patient-focused company that will inspire and empower you to grow throughlife-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers,encourages innovation, and strives for excellence in everything we do. Wefoster an inclusive, collaborative workplace, in which our teams are united byan unwavering commitment to deliver Better Health and a Brighter Future topeople around the world.#LI-SB1
• Takeda Compensation and Benefits Summary
• We understand compensation is an important factor as you consider the nextstep in your career. We are committed to equitable pay for all employees, andwe strive to be more transparent with our pay practices.
• For Location :
• Lexington, MA
• U.S. Base Salary Range :
• 96,600.00 - 151,800.00The estimated salary range reflects an anticipated range for this position.The actual base salary offered may depend on a variety of factors, includingthe qualifications of the individual applicant for the position, years ofrelevant experience, specific and unique skills, level of education attained,certifications or other professional licenses held, and the location in whichthe applicant lives andor from which they will be performing the job. Theactual base salary offered will be in accordance with state or local minimumwage requirements for the job location.U.S. based employees may be eligible for short-term and or long-termincentives. U.S. based employees may be eligible to participate in medical,dental, vision insurance, a 401(k) plan and company match, short-term andlong-term disability coverage, basic life insurance, a tuition reimbursementprogram, paid volunteer time off, company holidays, and well-being benefits,among others. U.S. based employees are also eligible to receive, per calendaryear, up to 80 hours of sick time, and new hires are eligible to accrue up to120 hours of paid vacation.
• EEO Statement_
• Takeda is proud in its commitment to creating a diverse workforce andproviding equal employment opportunities to all employees and applicants foremployment 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, orother protected veteran in accordance with applicable federal, state and locallaws, and any other characteristic protected by law._##
• Locations
• Lexington, MA##
• Worker Type
• Employee##
• Worker Sub-Type
• Regular##
• Time Type
• Full time
• Job Exempt