We are looking for an experienced and motivated individual to lead the implementation and operation of Early Phase Clinical Testing for GLP and GMP drug substance (DS) and drug product (DP) for all small molecule, biologic and conjugate modalities. The Head of Early Clinical Testing will be responsible for coordinating and execution of all aspects of clinical testing related to DS and DP which is produced internally in Takeda. Additionally, to lead technical interactions with contract laboratories and to lead interface activities especially with Global Manufacturing and Quality.
Provide leadership and overall management of early phase clinical testing activities, external partnerships and Interface management across all sites (Cambridge, MA; Lexington, MA; Shonan, Yokohama, Japan)
Oversee and manage the phase appropriate method validation and testing (IPC, release and stability) of early phase clinical trial material for small molecules, biologics and conjugates.
Partner across all PS functions, especially with PS Global Manufacturing Operations, in addition to Global Regulatory Affairs, Global Manufacturing Sciences and Global Quality to provide testing support for early phase clinical trial material
Work closely with internal and external partners to ensure seamless coordination and transfer of information, and will be responsible for ensuring that all testing activities are conducted efficiently and effectively
Direct and indirect supervisory responsibilities in analytical areas for development of high-quality therapeutics (proteins, small molecules, conjugates, …)
Support the finalization and implementation of a new Early Clinical Testing Strategy
Ensure that all early clinical testing activities are conducted in compliance with regulatory requirements and industry standards, and that the results are reported accurately and in a timely manner.
Lead and implement a hoteling system for IPC, release and stability testing in Analytical Development in cooperation with PS Global Manufacturing Operations
Develop, implement and execute a smart sourcing strategy. Including management of technical interactions with internal partners and contract laboratories
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 countries
Strong knowledge of ICH and other regulatory guidelines including Quality by Design
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
Direct experience in analytical development for synthetic molecules, biologics and conjugates 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
Deep and broad knowledge of analytical chemistry of multiple modalities in support of drug substance and drug product release and stability method development, raw material control and in process control testing
Proven working knowledge of current GMPs, ICH guidelines including Quality by Design, other regulatory requirements, and various quality system
Exceptional problem solving and troubleshooting skills related to analytical methodology
Ability to create collaborative and trusting relationships internally and with external partners.
Other professional competencies include: building authentic relationship, global and cross-boundary communication, excellence in execution, courage to challenge, inspiring and motivating others
What Takeda can offer you:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
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No Phone Calls or Recruiters Please.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range: $198,000.00 to $283,000.00. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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
Cambridge, MAWorker Type