Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a CMC Scientist in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a CMC Scientist working on the New Modality Development team, you will be empowered to develop processes for cell therapies that will be transformative to patients and work with cross-functional teams to move these therapies into the clinic and beyond, and a typical day will include: POSITION OBJECTIVES:
- Provides theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area.
- Independently plans and executes most unit operation characterization and optimization experiments within expertise and develops an awareness of unit operations in other areas.
- Responsible for significant or sole technical leadership within project or complex study.
- Prepares technology transfer documentation and regulatory documents or coordinates with team members to ensure execution.
- Represents line functions on GCT teams as appropriate/necessary.
- Proactively identifies process or study issues/challenges and proposes potential resolutions.
Qualifications: LINE FUNCTION SPECIFIC QUALIFICATIONS:
- 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
Biologics – New Modalities:
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: Education and Experience:
- Experience in the development and scaling of cell-based therapeutics such as stem cells or CAR-T cells.
- Hands-on experience in the genetic modification of human primary cells.
- Familiarity with evolving regulatory expectations for cell therapies, including considerations regarding comparability and product characterization.
Knowledge and Skills:
- 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, 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
- 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
WHAT TAKEDA CAN OFFER YOU:
- May require approximately 5-10% travel.
Empowering Our People to Shine
- 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
Learn more at takedajobs.com
. Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx No Phone Calls or Recruiters Please.
A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.