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Job Description OBJECTIVES: - Lead and develop a team of managers and scientists in the field of analytical controls and compliance
- Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all local project-related analytical control topics, development requirements and program milestones including global reporting
- Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas a) GMP review and control for analytical documents b) Release testing oversight, Stability and Shelf life c) Reference Standard Management d) GMP Quality Systems
- Contribute to product development and product quality oversight from Research to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process and product knowledge and control. Including the support of transfer of development assets from Research, main ownership commencing at start of GMP activities until hand-over to the commercial organization.
- Contribute to overall functional direction globally and represent function within CMC/Pharmaceutical Science and across the global Takeda organization.
ACCOUNTABILITIES:- Responsibility for people and group management. Inspire confidence in team members and lead the organization culture, promoting a healthy and inclusive working environment. Build future leadership while mentoring direct reports and junior employees.
- Demonstrates project oversight and leadership and cross-functional awareness to advance the line function regionally and globally. Close alignment and collaboration with other global AC leads in Japan and EU.
- Manages complete line function responsibility for all departmental programs and initiatives. Provides strategic guidance across projects that involve extraordinary, well-considered risks.
- Approve regulatory submission relevant sections, PS usage and justification documents (when applicable)
- Contributes and manages strategies for regional and global departmental infrastructure, resources, projects, etc. in conjunction with senior staff and global line and function heads
- Support and implementation of wider cross-functional/cross divisional strategy and decisions and drives initiatives to completion. Support of global CMC and Quality key initiatives and representation of PharmSci to other cross functional stakeholder key initiatives
- Analyze and synthesize concepts from diverse information -and articulate
- Contribute and drive vision and direction of departmental activities and infrastructure with specific focus but not limited to compliance, quality, systems and processes for AD and PS
- Focus on harmonisation and standardisation of AD but also PS processes, reporting, systems and documents in collaboration with Quality. Establishes and manages operational processes within the department/function.
- In collaboration with commercial functions, develop and implement aligned strategies to control quality of drug substances and products based on the current Good/Laboratory/Manufacturing Practice (cGMP, cGLP) regulations
- Benchmarks current trends within industry for all areas within Analytical Controls also including strategic development in alignment and collaboration with partners and stakeholders
- Directs and manages outsourcing strategy for department in conjunction with senior staff and global line and function heads
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:- Bachelors degree and 18+ years relevant industry experience
- Masters and 16+ years relevant industry experience
- PhD and 10+ 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
- GMP and compliance experience required
- Analytical method development 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 (oral and written)
- People managerial experience preferred
- 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
More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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:Boston, MA
U.S. Base Salary Range: $169,400.00 - $266,200.00
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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
