Digital Drug Product Development Associate Scientist
- Employer
- Takeda
- Location
- Lexington, Massachusetts
- Start date
- Jan 10, 2025
View more categoriesView less categories
- Discipline
- Information Technology, Marketing, Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
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Job DescriptionAbout 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
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
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 the world.
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Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MAU.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, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage 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 and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Company
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future
For more information, visit https://jobs.takeda.com/
- Website
- https://www.takeda.com/
- Location
-
650 East Kendall Street
Cambridge
MA
02421
United States
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