Posted to MedZilla on 10/18/2017


Takeda Pharmaceuticals

US-MA, Staff Engineer - Cell Culture Process Development 1702031-MZ


 
 

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 Staff Engineer - Cell Culture Process Development in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Staff Engineer working on the Biologics-New Modalities team, you will be empowered to develop robust cell culture processes and interact with a variety of teams to achieve your goals, and a typical day will include:


POSITION OBJECTIVES:


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.


POSITION 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.

LINE FUNCTION SPECIFIC QUALIFICATIONS

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.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:


Education and Experience:
Required:

  • Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
  • Masters 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+ years relevant 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

Knowledge and 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
  • 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

TRAVEL REQUIREMENTS:

  • May require approximately 5-10% 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

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-SM1-USA


Schedule

Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.