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 Senior Scientist, Analytical Development Small Molecules in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Scientist working on the Analytical Development Small Molecules team, you will be empowered to be the Analytical Development Small Molecules representative on CMC teams and contribute significantly to regulatory filings, and a typical day will include:
As a Senior Scientist working in Analytical Development Small Molecule, primary job objectives include:
- Develops a project or significant technical strategy within area of expertise
- Leverages analytical technical skill(s) as a resource/expert within Analytical Development
- Prepares and coordinates completion of technology transfer documentation, CMCC sections of regulatory documents, or validation plans and reports within expertise for review
- Coordinates transfer of projects as necessary
- Identifies and plans broader technical objectives (project and scientific related) with input from manager as needed
- Identifies and recommends vendors as appropriate
- Coordinates cross-functional teams and resolutions, with a focus on scientific /technical challenges.
- Develops and leverages strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMCC and other development functions
- Contributes significantly to complex/multiple projects or functional areas through leading or influencing others
- Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
- Reviews, interprets and communicates data cross functionally within CMC and project teams. .
- Coordinates others in creating technical reports including reviewing and editing
- Conducts analysis of technical and conceptual risk and trends
- Identifies process trends and defines/champions process strategy or use of novel technologies
- Recognized as a technical expert and resource within function
- Significant technical responsibility for a project area/technical program within the department and potentially across CMC (i.e. CMC team lead).
- Represents functional area on CMC project teams by communicating activities from designated functional area to project team
- Identifies topics for initiatives and leads local/global initiatives as directed by senior staff.
- Ensures a productive and development-rich environment; provides training/mentoring for junior staff.
- Defines more complex/novel approaches and methodologies to solving complex technical challenges
- Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
- Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.
- Initiate and influence project direction outside department.
- Mentor and work along-side junior scientists in Analytical Development to support Analytical Development project activities.
EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
- Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years relevant industry experience
- Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years relevant industry experience
- PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience
- 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
- Previous experience contributing to regulatory filings
- Strong knowledge of analytical techniques with advanced experience in multiple techniques such as LC, GC, MS, dissolution, etc
- Able to work in lab setting
- Experience representing Analytical Development in a cross functional CMC environment
- Multiple experiences with methods development, validation and transfer
- Ability to design and direct analytical strategy to meet CMC project objectives.
Knowledge and Skills:
- Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions
- Teamwork -- Ability to work well on global cross-functional teams.
- 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 with senior management; technical writing skills to support authorship and approval of internal technical documents
- Organization Exercises good time management and prioritization skills to balance multiple project and departmental objectives
- Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors
- Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
- Resource Management -Project management skills; ability to manage one s time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)
- External Involvement Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects
- Leadership Skills Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives
- May require approximately 10% travel.
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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.