Takeda
Associate Director, AD Strategy and Operations
Takeda, Boston, Massachusetts, us, 02298
Job Description
Objective / Purpose:
Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.Global CMC program oversight of PS with management of all project-related analytical topics, development requirements and program milestones including global reporting
Develop and set vision and direction of departmental activities and infrastructure, including but not limited to establishing and driving line function strategies, program managements, resources, and budgets
Local CMC program oversight related to analytical development, testing, and characterization, including management of milestone and risk reporting locally and globally; provide training to AD functional representatives.
Responsibility for people and (matrix) group management
As PS Lead, lead PS Team as a liaison between the Global Product Team (member)/DDU and CMC sub-team leads; evaluate and escalate risks/issues from a CMC perspective in a pro-active and constructive way
As AD rep (ADR), lead AD sub-team as an AD functional representative to complete development activities;
own release specification strategy and Justification of Specification documents ; identify and execute the most appropriate approach to AD deliverables in alignment with CMC development strategy and AD business practices/analytical strategies; track progress toward all AD activities and milestones;
act as a Point of Contact (POC) on the PS Team to evaluate and escalate risks/issues from an AD perspective in a pro-active and constructive way.
Accountabilities:Coordination and assignment of ADRs in collaboration with local heads/leads ( Global and Regional ADR coordination )
Management of mentor assignment, oversight on mentoring activities and ADR training curriculum (
Mentoring, training and coaching of ADRs
)
Hold mentoring session with ADRs and provide guidance and suggestions for program management including CMC development strategy, regulatory submission strategy, quality/analytical control strategy, and specification justification strategy (
Mentoring, training and coaching of ADRs
)
Technical guidance, risk management assessment and escalation via oversight of local programs (
Regional program oversight
)
Approve regulatory submission, specification and justification documents (when applicable) (
Regional program oversight
)
Harmonize the internal AD processes between sites and between modalities (
Harmonization of internal AD processes for programs
)
Proactively builds relationships with key partners/stakeholders to gain access to understanding to deliver on pipeline goals (
Point of contact for PS partners and stakeholders for global processes
)
Drives the vision/culture for the operation of the department, and set direction of departmental activities (operational processes) and infrastructure, including but not limited to establishing and driving line function strategies, program managements, resources, and budgets (
Departmental operations
)
Works with senior management to develop and set vision and direction of departmental activities (operational processes) and infrastructure, including but not limited to establishing and driving line function strategies, program managements, resources, and budgets (
Departmental operations
)
Organizational (matrix) leadership of team/group within a department. Management of internal or external teams (previous managerial experience preferred), accountable for the performance and results. Strategic impact/influence across a departmental area within Function by having accountability for performance and results of team (
people management
)
Designated PS team lead or lead of a cross functional team ( PS lead, initiative/workstream lead)
Cross functional leadership of complex projects; accountability for programs by leading AD sub-team to complete analytical development activities (
AD rep
)
Author and review regulatory submission content of which AD is responsible for including but not limited to specification and justification documents (
AD rep
)
Representing their functional area to a PS sub-team and coordinates with cross functional peers to evaluate the impact of decisions across PS and other development functions (
AD rep
)
Leadership and technical guidance for team members
Represents Takeda with external partners
Education & Competencies (Technical and Behavioral):Masters and 13+ years relevant industry experience or PhD and 7+ years relevant industry experience
Minimum of 7 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP’s
Demonstrates effective project management skills
Teaching and mentoring experience required
Analytical method development experience required
GMP and compliance experience required
Regulatory submission experience required with basic knowledge for regulatory guidelines
Global cultural awareness, manage inclusively
Familiarity with working in a global setting
(Specific skills required follows)
Excellent command of English is highly preferred (oral and written)
Team player with flexible personality but able to be persistent and assertive
Highly reliable, self-motivated, responsible and curious personality open to learn and develop and a pronounced desire for improvement
#J-18808-Ljbffr
Objective / Purpose:
Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.Global CMC program oversight of PS with management of all project-related analytical topics, development requirements and program milestones including global reporting
Develop and set vision and direction of departmental activities and infrastructure, including but not limited to establishing and driving line function strategies, program managements, resources, and budgets
Local CMC program oversight related to analytical development, testing, and characterization, including management of milestone and risk reporting locally and globally; provide training to AD functional representatives.
Responsibility for people and (matrix) group management
As PS Lead, lead PS Team as a liaison between the Global Product Team (member)/DDU and CMC sub-team leads; evaluate and escalate risks/issues from a CMC perspective in a pro-active and constructive way
As AD rep (ADR), lead AD sub-team as an AD functional representative to complete development activities;
own release specification strategy and Justification of Specification documents ; identify and execute the most appropriate approach to AD deliverables in alignment with CMC development strategy and AD business practices/analytical strategies; track progress toward all AD activities and milestones;
act as a Point of Contact (POC) on the PS Team to evaluate and escalate risks/issues from an AD perspective in a pro-active and constructive way.
Accountabilities:Coordination and assignment of ADRs in collaboration with local heads/leads ( Global and Regional ADR coordination )
Management of mentor assignment, oversight on mentoring activities and ADR training curriculum (
Mentoring, training and coaching of ADRs
)
Hold mentoring session with ADRs and provide guidance and suggestions for program management including CMC development strategy, regulatory submission strategy, quality/analytical control strategy, and specification justification strategy (
Mentoring, training and coaching of ADRs
)
Technical guidance, risk management assessment and escalation via oversight of local programs (
Regional program oversight
)
Approve regulatory submission, specification and justification documents (when applicable) (
Regional program oversight
)
Harmonize the internal AD processes between sites and between modalities (
Harmonization of internal AD processes for programs
)
Proactively builds relationships with key partners/stakeholders to gain access to understanding to deliver on pipeline goals (
Point of contact for PS partners and stakeholders for global processes
)
Drives the vision/culture for the operation of the department, and set direction of departmental activities (operational processes) and infrastructure, including but not limited to establishing and driving line function strategies, program managements, resources, and budgets (
Departmental operations
)
Works with senior management to develop and set vision and direction of departmental activities (operational processes) and infrastructure, including but not limited to establishing and driving line function strategies, program managements, resources, and budgets (
Departmental operations
)
Organizational (matrix) leadership of team/group within a department. Management of internal or external teams (previous managerial experience preferred), accountable for the performance and results. Strategic impact/influence across a departmental area within Function by having accountability for performance and results of team (
people management
)
Designated PS team lead or lead of a cross functional team ( PS lead, initiative/workstream lead)
Cross functional leadership of complex projects; accountability for programs by leading AD sub-team to complete analytical development activities (
AD rep
)
Author and review regulatory submission content of which AD is responsible for including but not limited to specification and justification documents (
AD rep
)
Representing their functional area to a PS sub-team and coordinates with cross functional peers to evaluate the impact of decisions across PS and other development functions (
AD rep
)
Leadership and technical guidance for team members
Represents Takeda with external partners
Education & Competencies (Technical and Behavioral):Masters and 13+ years relevant industry experience or PhD and 7+ years relevant industry experience
Minimum of 7 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP’s
Demonstrates effective project management skills
Teaching and mentoring experience required
Analytical method development experience required
GMP and compliance experience required
Regulatory submission experience required with basic knowledge for regulatory guidelines
Global cultural awareness, manage inclusively
Familiarity with working in a global setting
(Specific skills required follows)
Excellent command of English is highly preferred (oral and written)
Team player with flexible personality but able to be persistent and assertive
Highly reliable, self-motivated, responsible and curious personality open to learn and develop and a pronounced desire for improvement
#J-18808-Ljbffr