Associate Director, Analytical Development, Bioanalytics Late Stage

Description

Objective / Purpose :

As an Associate Director in Analytical Development, it is expected that the individual will independently lead efforts in development of appropriate scientific methods and technology, implementation of evolving scientific technology, drive team objectives and manage team performance in line with Pharmaceutical Sciences’ strategy to deliver on program strategy and initiatives.

The individual is expected to have acquired expertise in benchmarking analytical development trends within industry and demonstrate an in-depth working knowledge of Pharmaceutical Sciences and other partner organizational (Research, GMSGQ) roles and program strategy.

Accountabilities :

Expected to independently conduct technical analyses and risk assessments to build knowledge of processes, methods, and to inform related strategies across program and potentially across Pharmaceutical Sciences especially for Bioanalytics for late stage Biologics programs

Manage staff with accountability for performance and talent development

Works with senior management to develop and set vision for departmental activities and management of resources.

Ownership of Bioanalytics late stage area, responsible for establishing and managing operational processes within the department and influencing scientific and process improvement in global AD.

Strong knowledge of ICH and other regulatory guidelines including Analytical Quality by Design (AQbD)

Experience in reviewing and approving analytical-related CMC sections of BLA / MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics

Represents AD and provide guidance to PST teams by leveraging cross program learning, demonstrating ability to understand and communicate impact of technical and project risks on program timelines and other PS functions

Reviews and interprets complex data, industry trends and incorporates into strategy to communicate clearly to PS functional leadership and partner functional leadership as appropriate.

Driving vendors and sourcing / consultancy strategy both internally and externally.

Responsible for developing AD skill set to enable department vision, and management of team performance, engaging with external professional / scientific community, may drive publication strategy

Complete all required training appropriate to role and function in a timely manner

Education & Competencies :

Bachelors degree with 15+ yrs relevant experience, Masters degree with 13+ yrs relevant experience, Ph.D. with 7+ yrs relevant experience

Provides technical / managerial leadership for analytical function, in-depth understanding of PS deliverables and program timelines, driving program strategy, demonstrating leadership in functional and cross functional teams

Able to communicate to cross functional senior leadership on technology implementation strategy, able to lead or contribute in cross functional teams and ways of working, provide guidance around project leadership and strategy to team members as well as technical guidance

Takeda is proud in its commitment of 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, MA

Lexington, MA

U.S. Base Salary Range :

$149,100.00 - $234,300.00

The 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-termincentives. 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

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time