• Takeda Pharmaceuticals International GmbH
  • $94,360.00 -141,170.00/year*
  • North Attleboro, MA
  • Financial Services - Banking/Investment/Finance
  • Full-Time
  • 130 E Washington St

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda??s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the world??s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. We are a passionate team doing important work that impacts patients?? lives. If you are driven to create better health and a brighter future, join us! What makes a successful member of our team? Check out the traits we??re looking for and see if you have the right mix. Recognized for our culture and way of working, we??re one of only select companies to receive Top Global Employer status for 2019. Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do??from decision-making to interacting with patients. Recognized for our culture and way of working, we??re one of only 13 companies to receive Top Global Employer status for 2018. Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention. This individual will be a member of the group responsible for developing GMP cell bank manufacturing processes for clinical and commercial programs; defining appropriate characterization activities for evaluation of production cell banks and cell lines, and managing cell banking activities throughout the program lifecycle. Key responsibilities: Providing technical leadership in developing GMP cell bank manufacturing processes, characterization and testing strategy Identifying and driving technical innovations leading to improvements of production cell lines and cell banking processes Building strong collaborations with cell line development, cell bank manufacturing, quality control and regulatory groups to align activities to rapidly advance Takeda pipeline Drafting/reviewing the content of relevant the CMC sections of regulatory dossiers, supporting regulatory queries and inspections. Providing input into organizational policies and guidance documents related to cell bank life cycle management Mentoring and enhancing staff performance Responsibilities 40% Development related work and associated documentation Identifies the objectives of cell banking group Oversees the timely development, characterization testing of cell banks, communicates with the departments involved Manages preparation of internal documents, reviews SOPs, study reports project summaries in the area of cell culture process development, cell banking and testing 30% Regulatory support Authors relevant CMC sections of US and international regulatory submissions and addresses post-registration questions Serves as subject matter expert for regulatory inspections in the areas of cell banking process, cell bank and cell line characterization and testing Designs and directs the studies to address post marketing commitments 10% Evaluation of new technologies Provides technical leadership in the pursuit of new technologies for improvements of cell line performance as well as cell banking process with the ultimate goal of rapid generation of clinical material meeting quality targets 20% Organization support and cross functional responsibilities Works with the manager to identify and drive group??s goals; coordinates/leads the activities of cross functional project teams, and interdepartmental teams. Serves as a liaison and provides PDB input to cell line development function Effectively leads, trains and mentors group of direct reports Education and Experience Requirements PhD in Biological Sciences or Engineering degree; > 8 years of relevant experience including 4-6 years the industry Proficiency in regulatory requirements for drug development and cell banks manufacturing and testing Excellent writing skills including authoring regulatory filings are required. Key Skills, Abilities, and Competencies Knowledge and industry expertise of advanced scientific principles, practices and standards to biologics process and product development Current scientific knowledge and latest technologies in areas of cell line development, cell banking and cell culture process development Knowledge and understanding of the regulatory guidelines and working experience in the GLP and GMP environment Ability to deliver results consistently and effectively Ability to communicate across all levels of an organization and efficiently coordinate activities with both internal and external customers. High degree of self-motivation Ability to quickly adapt to changing business conditions Complexity and Problem Solving Independently defines his/her assignment objectives based on the input from management, designs and directs experimental strategies to be carried out by others. Makes sound and timely decisions on deliverables and resources based on corporate and functional priorities Independently leads the design and execution of studies to troubleshoot issues encountered during development or GMP manufacturing. Provides high quality drafts of relevant CMC sections of regulatory filings and submissions addressing post-registration questions; proposals for development and research projects, publications in field of expertise. Reviews/approves documents such as protocols, memos, data summaries, reports and procedures Presents at department and cross-functional gatherings, project team meetings and external meetings. Works with management to review progress and strategy in meeting team objectives. Internal and External Contacts Sr. Director, Upstream Development and his staff Quality Control staff Global Regulatory staff Vendor Contract Manufacturing Organizations Notice to Employment / Recruitment Agents: Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda??s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Equal Employment Opportunity Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. EEO is the Law - EEO is the Law ?? Supplement - Pay Transparency Policy - Reasonable Accommodations Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-###-#### and let us know the nature of your request and your contact information. Search for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click ??Add? to create your job alert. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Takeda Pharmaceuticals. Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: 2) file a complaint with the U.S. Federal Trade Commission: and/or 3) file a report with your local police department.
Associated topics: associate director, chief financial officer, controller, general operational manager, manage, operation, operational manager, president, staff, vice president

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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