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Job Description
OBJECTIVES:
Lead and develop a team of managers and scientists and their teams in the field of analytical development in the field of late stage biologics
Oversee and manage phase-appropriate analytical development for clinical trial material efforts across three main areas: a) Characterization and comparability, b) Method development of methods for non-routine and release/stability use, c) Method development for In-Process analytics across all required analytical techniques (including but not limited to HPLC, mass spectrometry, immunological and potency assays, …)
Contribute to product development from Pharmaceutical Sciences to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process and product knowledge. Including transfer of development assets to the commercial organization.
Contribute to overall functional direction globally and represent function within CMC/Pharmaceutical Science and across the global Takeda organization.
Implement and execute externalization activities with external partners, facilitate development of execution plans for each, and ensure completion of agreed upon activities
ACCOUNTABILITIES:
Direct and indirect supervisory responsibilities in analytical areas for development of high-quality late stage biologics therapeutics (complex proteins, ADCs, mAbs, engineered mAbs…)
Drive global late stage team to obtain scientific data; data compilation and review; preparation and review of technical reports, global regulatory filings, and other documentation; project/CMC team representation/leadership; technical interactions with internal partners and contract laboratories
Collaborate with other functions in Pharmaceutical Sciences to encourage strategic alignment and successful achievement of shared goals
Be well versed in all stages of analytical development and understand the global regulatory trends for CMC activities, to ensure robust and high-quality regulatory filings in all major countries
Develop, implement and execute a smart sourcing strategy
Lead global CMC key initiatives and represent Pharmaceutical Science to other cross functional stakeholder key initiatives
Manage functional area budget and human resources to be within required limits
Drive continuous improvement in the technology, methodology and business processes used to support analytical development, characterization and associated operational and documentation systems
Strong knowledge of ICH and other regulatory guidelines including Quality by Design
Maintain an active understanding of the future trends of medicine to build an organization adaptable for the future
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
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Master or PhD in chemistry, biology, pharmacy, or related pharmaceutical science; at least 10 years relevant industry experience including significant experience in analytical science, cGMP compliance, CMC regulatory requirements in multiple analytical development areas
Leadership experience of teams including managers and scientists. Development of team members to managers of scientific analytical teams including individual contributors with an exceptional commitment to science
Direct experience in analytical development for biologics, especially late stage assets, and ability to drive study completion in a timely, sustainable, robust and cost-efficient manner
Drive decision making within a cross-functional, cross-cultural global team structure
Knowledge and experience with product development and clinical supply processes and product commercialization. Quality experience is of advantage
Experience in reviewing and approving analytical-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics
Develop, implement and execute a smart sourcing strategy
Deep and broad knowledge of analytical chemistry of biologics in support of drug substance and drug product release and stability method development, raw material control, in process control, and characterization
Exceptional problem solving and troubleshooting skills related to analytical methodology
Proven working knowledge of current GMPs, ICH guidelines including Quality by Design, other regulatory requirements, and various quality system
Proven knowledge, skills, and abilities with statistical analysis (with emphasis on analytical testing applications).
Knowledge of complex and state-of-the-art methodology for biologics GMP method development and characterization
Proven ability to work efficiently and effectively as a leader of managers and scientists
OPEX and CAPEX budget planning and controlling skills and efficient resource planning
Strong verbal, presentation, and written communication skills. Can concisely articulate and deliver effective presentations on complex technical issues to non-technical audience.
Ability to create collaborative and trusting relationships internally and with external partners.
Requires strong organizational skills and attention to detail for composing and proofing materials, scheduling, establishing priorities, and meeting deadlines.
Other professional competencies include: building authentic relationship, global and cross-boundary communication, excellence in execution, courage to challenge, inspiring and motivating others
TRAVEL REQUIREMENTS:
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:
Boston, MA
U.S. Base Salary Range:
$205,100.00 - $322,300.00
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-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.
Locations
Boston, MA
Vienna, Austria
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
