|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:
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
- 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:
- Bachelors degree in chemistry, biology,
pharmacy, engineering or related pharmaceutical science and 8+ years relevant
- Masters degree in chemistry, biology, pharmacy,
engineering or related pharmaceutical science; 6+ years relevant industry
- PhD in chemistry, biology, pharmacy, engineering
or related pharmaceutical science; 2+ 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
- Previous experience with the use of contract
- Experience in working in a multi-disciplinary
- 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
- 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
- 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
- May require approximately 5-10% travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
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