Scientist - Analytical Development Early Stage

Takeda • Cambridge, MA

1d • $116,000 - $182,270

About The Position

As a Scientist working in the Analytical Development Early Development team, you will be empowered to lead technical activities and represent Analytical Development Early Development within departmental and cross-functional team. POSITION OBJECTIVES: Support the transition of novel compounds (synthetic molecules, Oligonucleotide, Protacs) from Discovery into Development and development activities to support FIH clinical studies. The role will also involve continued research efforts throughout the developmental lifecycle of compounds across a wide range of activities. Interaction with Discovery Teams, Drug Safety , DMPK and close collaboration with Process Chemistry, Formulation development and Late Phase Analytical Development to achieve project goals. A strong focus will be on salt/polymorph screening, solid state analytics and analytical method development for API and Drug Product

Requirements

• Bachelors degree in Pharmaceutics, analytical chemistry, organic chemistry, or related pharmaceutical science with 8+ years of relevant industry experience
• Masters degree in Pharmaceutics, physical organic chemistry, analytical chemistry, or related pharmaceutical science with 6+ years of relevant industry experience
• PhD in relevant discipline with 0+ years of relevant industry experience
• Strong understanding of polymorphism and solid state screening techniques
• Strong understanding of solid state analytical techniques (XRPD/DSC/TGA/DVS)
• Strong understanding of analytical method development (HPLC/GC/KF/Dissolution) and cGMP
• Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and identify/implement possible solutions
• Teamwork -- Ability to work well in highly cross functional team environment
• Communication Skills -Able to expresses one’s self clearly and concisely within teams; documents issues and/or concerns concisely with colleagues; timely and effective communication of 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
• Resource Management -Ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
• Technical - strong knowledge analytical theory along with hands on experience in multiple analytical techniques (DSC, TGA, HPLC, XRPD, GC, etc) and proven ability to work in a lab setting.

Nice To Haves

• Working knowledge of modalities outside of traditional small molecule (Oligonucleotides, Protacs) and in silico predictive tools/modeling highly valued

Responsibilities

• Independently design, plan and execute studies on new development candidates to elucidate fundamental physicochemical properties and behaviors that enable lead candidate selection and downstream CMC development.
• Contributes to and drives solid state screening activities
• Lead physicochemical profiling efforts and analytical method development
• Contributes to a cross-functional Pharmaceutical Sciences team responsible for overseeing API salt and polymorph selection and subsequent development activities
• Develops analytical methods for release of GMP API and Drug Product.
• Responsible for significant technical leadership within a project and assist in project strategy development across projects within the department or cross functionally
• Interfaces with individual Pharmaceutical Science colleagues and cross functional project teams to ensure that development activities are consistent with physicochemical properties of API
• May serve as a technical expert/SME for mentoring of junior team members
• Responsible for integrating scientific/technical efforts around cross functional issues
• Plans and implements resolutions to technical problems/issues
• Supports local initiatives which may include technical or process related work streams
• Authoring of technical reports and contributes to regulatory filings

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees