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Job Details

Associate Scientific Fellow / Senior Scientist Analytical Development - Biologics

Company name
Takeda Pharmaceutical Company Limited.

Location
Boston, MA, United States

Employment Type
Full-Time

Industry
Sciences, Scientist, Post Doc, Chemistry, Engineering, Pharmaceutical

Posted on
Sep 11,2019

Valid Through
Dec 25,2019

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Job Description

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 an Associate Scientific Fellow / Senior Scientist, Analytical Development – Biologics in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Scientific Fellow / Senior Scientist working on the Analytical Development - Biologics team, you will be empowered to develop and leverage your technical skills to contribute to Takeda's mission and work with cross-functional project teams, and a typical day will include:

POSITION OBJECTIVES:

Develops project or significant technical strategy within area of expertise

Leverages technical skill(s) as a resource/expert within the department and across division to contribute across multiple projects

Prepares and coordinates completion of technology transfer documentation, CMC 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) and initiates processes to meet objectives with input from manager as needed

Identifies and recommends vendors as appropriate

Directs and manages outsourcing across a product platform as appropriate

Coordinates cross-functional teams and resolutions, with a focus on scientific/technical challenges                                

POSITION ACCOUNTABILITIES:

Significant technical responsibility for a project area/technical program within the department and potentially across CMC (i.e. Global CMC Team lead)

Represents functional area on GCT project teams by communicating activities from designated functional area to project team 

Insures effective project management of all plans and projects with area of responsibility, linking all scientific efforts to company, program and functional goals

Develops and leverages strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMC 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 

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

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

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 

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 audienc; 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

LINE FUNCTION SPECIFIC QUALIFICATIONS:

Significant experience with a broad variety of biochemical analytical techniques, including but not necessarily limited to liquid chromatography, gel or capillary electrophoresis, spectrometry and spectroscopy methods

May have significant knowledge in specialized subdisciplines such as protein mass spectrometry or biophysics

Able to lead cross-program development activities for multiple methods

Able to conduct troubleshooting for complex technical issues and to lead major characterization studies

Strong understanding of protein structure/function and of technical and regulatory expectations regarding analytical development and product characterization

Serves as a SME for more complex methods

Defines critical technical or scientific gaps within AD-Bio

General lab competencies such as equipment maintenance and compliance activities

PHYSICAL DEMANDS:

Use hands on a regular basis to perform experiments and handle small laboratory equipment

Able to lift or move up to 40 pounds in the course of daily work

Exposure to hazardous/toxic chemicals and reagents

TRAVEL REQUIREMENTS:

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.

#LI-TRL

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID

R0005580

Company info

Takeda Pharmaceutical Company Limited.
Website : https://www.takeda.com

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