Senior Director, Analytical Development, Bioanalytics Late Stage
14 hours ago
As a Senior Director in Analytical Development, you will lead efforts in developing scientific methods and technology, implementing evolving scientific technology, and driving team objectives to deliver on program strategy and initiatives. You will have expertise in benchmarking analytical development trends within industry and demonstrate an in-depth working knowledge of Pharmaceutical Sciences and other partner organizational roles and program strategy.
Key Responsibilities- Conduct technical analyses and risk assessments to build knowledge of processes and inform related strategies across program and potentially across Pharmaceutical Sciences.
- Manage staff with accountability for performance and talent development.
- Work with senior management to develop and set vision for departmental activities and management of resources.
- Establish and manage operational processes within the department and influence scientific and process improvement in global AD.
- Review and approve analytical-related CMC sections of BLA/MAA regulatory submissions and have knowledge of European, Japanese, Chinese, and US CMC regulatory requirements for Biologics.
- Represent AD and provide guidance to PST teams by leveraging cross-program learning and demonstrating ability to understand and communicate impact of technical and project risks on program timelines and other PS functions.
- Review and interpret complex data, industry trends, and incorporate into strategy to communicate clearly to PS functional leadership and partner functional leadership as appropriate.
- Drive vendors and sourcing/consultancy strategy both internally and externally.
- Develop AD skill set to enable department vision and management of team performance, engage with external professional/scientific community, and drive publication strategy.
- Complete all required training appropriate to role and function in a timely manner.
- Bachelor's degree with 15+ years of relevant experience, Master's degree with 13+ years of relevant experience, or Ph.D. with 7+ years of relevant experience.
- Provides technical/managerial leadership for analytical function, in-depth understanding of PS deliverables and program timelines, driving program strategy, and demonstrating leadership in functional and cross-functional teams.
- Able to communicate to cross-functional senior leadership on technology implementation strategy, lead or contribute in cross-functional teams and ways of working, and provide guidance around project leadership and strategy to team members as well as technical guidance.
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws, and any other characteristic protected by law.
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Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MAU.S. Base Salary Range:
$149,100.00 - $234,300.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws, and any other characteristic protected by law.
LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time-
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