More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
Post : Senior Scientist, Process & Analytical Development, Cell Therapy
Job Description
POSITION OBJECTIVES:
This senior scientist position will play an important role in developing the clinical manufacturing processes and/or analytical methods for developing cellular therapy products. Independently plans and executes process and assay development, characterization and qualification studies. Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials. Presents study results at team or department meetings, to external partners or at conferences.
POSITION ACCOUNTABILITIES:
• Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
• Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks.
• Contributes significantly and independently to project work which may include multiple projects within functional area.
• Reviews, interprets and communicates data cross-functionally within CMC and/or project teams.
• Plans and implements resolutions to technical problems/issues
• Represents functional area on GCT project teams by communicating activities from designated functional area to project team
• Supports local and global initiatives which may include leading initiatives or work streams
• Serves as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/trainer.
• Independently designs and executes experiments, and reports results
• Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
• Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
• Proactively analyses manufacturing issues and coordinates potential resolution with the CMC team.
• Responsible for integrating scientific/technical efforts around cross-functional issues
Candidate Profile
• Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
• Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience
• PhD in chemistry, biology, pharmacy, chemical or biomedical engineering or related pharmaceutical science; 0+ years relevant industry experience
• Bachelors or Masters: Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s
• Sound knowledge of current Good Manufacturing Practices (cGMP)
• Previous experience with the use of contract facilities
• Experience in working in a multi-disciplinary team environment
• PhD: Demonstrated mastery of subject or area related to field
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Knowledge and Skills:
• Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
• Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
• Communication Skills -Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents
• Organization – Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
• Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
• Resource Management -Ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
• External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
• Technical - Subject matter expertise and knowledge of applicable lab equipment and operations
LINE FUNCTION SPECIFIC QUALIFICATIONS:
• Experience in developing cell therapy or biological products manufacturing processes, or experience in developing and executing cellular characterization assays, including flow cytometry-based, and multiplexed luminescent readouts
• In-depth experience in principles and practices of cell biology methodologies, cellular immunology or stem cell biology (e.g., induced pluripotent stem cells (iPSCs)), including cell culture, cell transfection and transduction, development and execution of functional in vitro and preclinical methods relevant for various types of immune cells or stem cells.
• Understanding and experience of using the tools of Design of Experiment (DOE) and Quality by Design (QBD) in process & assay design, development, qualification and validation.
• Understanding of viral transduction principles and processes is strongly preferred
• Previous exposure to GMP manufacturing of cell therapy or biological products, or participation in technical transfer of clinical processes to a CMO, or tech transfer of product release & characterization or clinical assays to a CRO, or other third party is a plus
• At least 4-6 years of biopharmaceutical industry experience in a development setting is preferred
Additional Information:
Experience : 1-6 years
Qualification : M.Sc, B.Pharm, Ph.D
Industry Type: Pharma
Location : Cambridge
Functional Area : Process & Analytical Development
End Date : 30th April, 2018
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