19 days old

Senior Scientist, Drug Product Development

Shire Human Genetic Therapies, Inc.
Boston, MA 02109
  • Job Code
    R0022399

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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 Cambridge, MA 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 Drug Product Development team, you will be empowered to design, execute and/or manages phase appropriate formulation and process development studies encompassing all activities from early phase formulation to manufacturing process validation.

OBJECTIVES/PURPOSE

The Senior Scientist is expected to provide technical leadership on product development activities encompassing different modalities including small molecules, microbiome, oligonucleotides and peptides. The Senior Scientist is responsible for independently planning and execution of drug product development activities including Drug Discovery support, Pre-formulation, Formulation/Process Development, Tech Transfer, Clinical Manufacturing and Regulatory Filing supports. The Senior Scientist line function on Pharmaceutical Sciences teams and will provide theoretical/conceptual input to the design, development and execution of research assignments for drug product development.

ACCOUNTABILITIES

  • Designs, executes and/or manages phase appropriate formulation and process development studies encompassing all activities from early phase formulation to manufacturing process validation with inputs from manager as needed.
  • Manage CROs and CMOs to support drug product development and GMP manufacturing of the drug product.
  • Responsible for drug product manufacturing activities at CMOs including master batch records, protocols GMP manufacturing, batch release, deviations, investigations, CAPAs and change controls.
  • Author/review internal development reports, CMC sections of IND/IMPD/NDA and responses in support of regulatory filings/queries.
  • Represent DPD group on cross functional CMC teams and leverage strategic understanding of the project and CMC priorities to plan/coordinate the drug product development studies with cross-functional peers.
  • Provide project progress updates/reports to manager to ensure management is engaged and aware of the project strategy, current activities and future needs.
  • Serves as subject matter expert and contributes actively to complex/multiple projects or functional areas through leading or influencing others.
  • Lead and support departmental (or cross functional) key initiatives to drive scientific and technical innovations.
  • Ensures a productive, respectful and development-rich environment; provides training/mentoring for junior staff.
  • Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.

DIMENSIONS AND ASPECTS

  • Comprehensive understanding of the pharmaceutical industry and Cell Therapy

Leadership

  • Demonstrated ability to work across functions, regions and cultures
  • Enterprise level leadership with the ability to inspire, motivate and drive results
  • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
  • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
  • Ability to distil complex issues and ideas down to simple comprehensible terms
  • Executive leadership presence and confidence
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
  • Ability to develop and drive a Global Workforce and Talent strategy for all colleagues in the Global, Regional and Local organizations

Decision-making and Autonomy

  • Broad decision-making responsibilities:
    • Ability to make highly complex decisions that impact the enterprise
    • Accountable for decision making for Cell Therapy
    • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
    • Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
  • Accountable for designing and implementing vision and strategy for designated scope

Interaction

  • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
  • Ability to effectively implement R&Ds partnership strategy
  • Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
  • Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions

Innovation

  • Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
  • Comfortable challenging the status quo and bringing forward innovative solutions
  • Ability to take risks implementing innovative solutions, accelerating time to market

Complexity

  • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
  • Breadth of knowledge required across therapeutic areas, indications, and/or modalities

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Must have a degree in a related scientific discipline.
  • BS with at least eleven (11) years, MS/PharmD with at least nine (9) years or a PhD with a minimum of three (3) years of experience in Product Development in the Pharmaceutical industry is required.
  • Extensive experience and demonstrated track record in several drug product development activities such as Drug Discovery support, Pre-formulation, Early phase formulation development, formulation characterization, manufacturing process development, tech transfer, scale up and validation.
  • Technical expertise in development of oral or parenteral products with demonstrated experience in one or more formulation techniques including but not limited to solubilization, spray drying, hot melt extrusion, nanoparticles, dry/wet granulation, tablet compression, Wurster process, tablet coating, encapsulation, liquid fill/finish and aseptic processing.
  • Good working knowledge of common analytical techniques such as HPLC, DSC, TGA, XRPD, IR/Raman spectroscopy and particle size analysis techniques.
  • Extensive experience in CMC pharmaceutical development for drug products under cGMPs.
  • Previous experience contributing to regulatory filings.
  • Ability to work independently, take initiatives, and complete tasks to meet the deadlines.
  • Strong team player.
  • Must be capable of handling multiple projects with competing timelines and must be able to make complex decisions.
  • Must possess solid communication skills as well as organizational skills.
  • Demonstrated leadership skills Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.

ADDITIONAL INFORMATION

  • Requires occasional travel to various meetings or vendor sites
  • Some international travel may be required
  • Hands-on laboratory work is required

TRAVEL REQUIREMENTS:

  • 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

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please

#LI-AA1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2020-09-03 Expires: 2020-10-02
Sponsored by:
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Senior Scientist, Drug Product Development

Shire Human Genetic Therapies, Inc.
Boston, MA 02109

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