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Senior Scientist, Drug Product Development

Lexington, Massachusetts

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention.

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Senior Scientist, Drug Product Development

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Job ID R0010097 Date posted 04/10/2020 Location Lexington, Massachusetts

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career?  If so, be empowered to take charge of your future at Takeda. Join us as a Senior Scientist, Drug Product Development in our Lexington office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. 

As a Senior Scientist working in the Biologics Drug Product Development team, you will be empowered to develop formulations for novel biologic molecules and transfer drug product manufacturing processes to global manufacturing sites.

POSITION OBJECTIVES:

  • Provides theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area (e.g., formulation screening by design of experiment, analyze data and create predictive models for protein stability). Leverages technical skill(s) as a resource/expert within the department.
  • Identifies and plans broader technical objectives (project and scientific related) and initiates processes meet objectives with input from manager as needed. Independently plans and executes characterization and optimization experiments (protein conformation and chemical stability) within expertise and develops new screening tools (e.g., chromatography, protein particle analysis).
  • Responsible for significant or sole technical leadership within project or complex study (e.g., design drug product manufacturing processes or protein formulation screening studies). Prepares technology transfer documentation and regulatory documents or coordinates with team members to ensure execution (e.g., author drug product manufacturing process documents, author regulatory filing documentation or section).
  • Represents line function on Global Chemistry Control (GCT) and Manufacturing Teams as appropriate/necessary (e.g., provide technical leadership or expertise on formulation development and drug product manufacturing).

POSITION ACCOUNTABILITIES:

  • Independently plans drug product developmental project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders to support clinical studies and commercial.
  • Provides technical leadership to drug product development project teams within area of expertise and commits resources to execute specific project tasks (e.g., protein formulation development and drug product manufacturing process).
  • Contributes significantly and independently to drug product formulation development work which may include screening multiple proteins within functional area.
  • Reviews, interprets and communicates data cross-functionally teams (e.g., protein stability data, drug product manufacturing process data).
  • Independently designs and executes experiments and reports results.
  • Plans and implements resolutions to technical problems/issues.
  • Coordinates others in creating technical reports including reviewing and editing.
  • Conducts analysis of technical and conceptual risk and trends.
  • Identifies process trends and defines/champions process strategy or use of novel technologies.
  • Represents functional area on GCTs by communicating activities from designated functional area to project team.
  • Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
  • Develops project strategy and communicates complex data/decisions within department and cross functionally.
  • Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations.
  • Responsible for integrating scientific/technical efforts around cross-functional issues. Leverages technical skill(s) as a resource/expert within the department.

EDUCATION,BEHAVIORALCOMPETENCIES AND SKILLS:

Required Education and Experience:

  • Bachelor’s degree in chemistry/biochemistry,biology,pharmacy, engineering or related pharmaceutical science and 11+ years relevant industry experience.
  • Master’s degree in chemistry/biochemistry,biology,pharmacy, engineering or related pharmaceutical science; 9+ years relevant industry experience.
  • Ph.D. in chemistry/biochemistry,biology,pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience.
  • Sound knowledge of current Good Manufacturing Practices (cGMP).
  • Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients (API) and drug products under cGMP.
  • Previous experience with the use of contract facilities.
  • Experience in working in a multi-disciplinary team environment.
  • Previous experience contributing to regulatory filings.

KNOWLEDGE AND SKILLS:

  • Protein formulation development experience preferred.
  • Experience with analytical methods used for protein analysis such as HPLC, CE, spectroscopy, and sub-visible particle analysis.
  • Knowledgeable about Design of Experiments and statistical principles for experimental design and data analysis.
  • Exposure to the development of combination products and drug antibody conjugates preferred.
  • Experience leading technology transfer to aseptic drug product manufacturers.

Additional Skills:

  • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions.
  • Teamwork - Ability to work well in highly cross functional team environment and across global line functions.
  • Communication Skills - Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents.
  • Organizational Skills – Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously.
  • Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
  • Resource Management - Ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors).
  • External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events.
  • Technical - Subject matter expertise and knowledge of applicable lab equipment and operations.
  • Leadership Skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.

TRAVELREQUIREMENTS:

May require approximately 10 - 20% travel.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

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Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0010097

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