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Staff Engineer, Cell Culture Process Development

Boston, Massachusetts

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Staff Engineer, Cell Culture Process Development

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Job ID R0023116 Date posted 10/06/2020 Location Boston, Massachusetts

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Job Description

OBJECTIVES/PURPOSE

The cell culture process development team is seeking an experienced scientist to contribute to the development and characterization of cell culture processes used in the production of protein therapies.

This position will participate in process transfer to internal and external manufacturing facilities and support manufacturing activities as needed. This position is expected to independently plan and execute studies and provide technical leadership to project teams, outside partners and contract organizations. 

ACCOUNTABILITIES

  • Responsible for executing cell culture development experiments in order to develop robust cell culture processes for the production of investigational and ultimately commercial products.
  • Responsible for execution of laboratory experimentation using bench top bioreactors, small scale expansion systems and high throughput systems. Activities include optimizing process controlling strategies, process characterization and evaluating overall process robustness.
  • Responsible for data analysis and communication of results within presentations and formal process development reports. Manages all activities associated with execution of experimentation and will participate in a team to design experiments and discuss results.
  • May be responsible for supporting global CMC team activities though acting as technical representative as well as providing input to CMC team activities and decisions.
  • Responsible for interacting with both internal and external manufacturing sites and supporting cell culture specific activities, such as technical transfer and process oversight.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Biologics - Cell Culture Process Development
  • Experience with mammalian-based fed batch culture processes and operation of  laboratory scale stirred tank bioreactors
  • Experience in statistical methodologies, such as Design of Experiments (DOE), to promote process modeling for application towards the development, characterization and robustness of a process. 
  • Familiarity with large scale manufacturing, technical transfer activities and working within quality systems is preferable.
  • Late stage process development experience, such as process characterization, is preferable. 

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 XXX 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&D’s 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, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
  • Master’s degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ yearsrelevant industry experience
  • Bachelors or Masters: Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s
  • Sound knowledge of current Good Manufacturing Practices (cGMP)
  • Previous experience with the use of contract facilities
  • Experience in working in a multi-disciplinary team environment
  • PhD: Demonstrated mastery of subject or area related to field\
  • 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
  • Organization – 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  

ADDITIONAL INFORMATION

  • May require approximately 5-10% travel

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023116

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