Manages all activities,
both upstream and downstream, within the pilot laboratory at Takeda Boston with
a small team of focused staff. This position will have strong interfaces with
development, manufacturing, both internal and external, and project management.
Must be hands-on and flexible with strong leadership skills in this fast
growing capability. Pilot team will be responsible for material supply,
scale up process design, trouble-shooting, several aspects of technical
transfer and in exploring innovative technology for pilot and cGMP
manufacturing. Manages constant effort in continuous improvement for both
operational and technical aspects of the pilot team. Identifies and recommends
vendors as appropriate. Identifies and plans broader technical objectives
(project and department related) and initiates processes to meet objectives
with input from manager as needed.
- Manages a team of both upstream
and downstream technical staff personnel
- Accountable for meeting pilot
team objectives such as production of batches for material supply,
technical transfer or for development.
- Responsible for capacity
planning and identification of critical risks and needs
- Responsible for capital and
infrastructure planning for pilot facility
- Coordinates cross-functional
teams and resolutions, with a focus on scientific/technical challenges.
- Develops and leverages
strategic understanding of project and CMC priorities to plan/coordinates
with cross functional peers and evaluate impact of decisions across CMCC
and other development functions
- Influences or assists
initiatives related to driving scientific and technical improvement within
function and potentially cross functionally.
- Contributes significantly and
independently to complex/multiple project work through advising and
guiding direct reports.
- Assists with the operations of
the group and department including resource planning, process
improvements, infrastructure, and initiatives.
- Reviews, interprets and
communicates data cross-functionally within CMC/project teams.
- Analyzes technical and
conceptual risk and trends and advises direct reports
- Coordinates the work of
coworkers and direct reports to create technical reports in own area
including reviewing and editing.
- Contributes to defining
departmental operational strategies
- Provides significant technical
leadership for a project area/technical program within the department and
potentially across CMCC (i.e. GCT lead).
- Represents functional area on
technical teams and provides guidance on potential impacts of proposed
actions on other disciplines/projects.
- Identifies initiative topics
and leads local/global initiatives as directed by senior staff.
- Defines more complex strategic
approaches and methodologies to achieve project goals and influence team
- Proactively identifies vendors
and builds relationships to gain access to technologies as needed to
deliver on pipeline goals. Proactively resolves issues arising at vendors.
COMPETENCIES AND SKILLS:
- Bachelors degree in chemistry,
biology, pharmacy, or related pharmaceutical science and 11+ years
relevant industry experience
- Masters degree in chemistry,
biology, pharmacy, engineering or related pharmaceutical science; 9+ years
relevant industry experience
- PhD in chemistry, biology,
pharmacy, engineering or related pharmaceutical science; 3+ years relevant
- Extensive experience in CMC
pharmaceutical development for active pharmaceutical ingredients and drug
products under cGMP s
- Experience with CHO based systems and proteins
- Sound knowledge of current Good
Manufacturing Practices (cGMP) and direct experience with cGMP
manufacturing is preferred
- Previous experience with the
use of contract facilities
- Experience in working in a
multi-disciplinary team environment
- Previous experience
contributing to regulatory filings
- Previous people management
Knowledge and Skills:
- Analytical and Problem Solving
Skills - Able to troubleshoot critical issues or problems and determine
causes and possible solutions
- Teamwork -- Works well on
global cross-functional teams; Demonstrated ability to foster a highly
efficient team environment.
- Communication Skills -Able to
expresses one s self clearly and concisely within team; documents issues
and/or concerns concisely with colleagues; adjusts communication style
appropriate for the audience; timely and effectively communicates with
senior management and direct reports; technical writing skills to support
authorship and approval of technical documents
- Organization Exercises good
time management and prioritization skills to balance multiple project and
- Technical - Subject matter
expertise in a specific scientific area or areas. Demonstrated ability to
successfully contribute across multiple scientific endeavors
- Knowledge Sharing - Ability to
capture organizational knowledge organization; 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 -Project
management skills; ability to manage the time of direct reports 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. Advises team members or directly interacts with external
vendors for projects
- Leadership Skills
Demonstrated ability to manage up and down the organization; Ability to
use appropriate management strategies to provide direction for the work of
team members and support individual development.
Must be willing to
support circumstances which may require weekend and evening coverage.
approximately 10% travel
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