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Company

Original Job Post

Takeda · 2 days ago

Senior Scientist, Process Analytics

Boston, MA

Full-time

Onsite

Senior Level

$133K/yr - $209K/yr

11+ years exp

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Responsibilities

Support project teams for development of research methods, preliminary isolation/identification of process impurities, reaction kinetics, reaction mechanism, and data management (in collaboration with Analytical Development).

Collaborate with drug substance process chemistry and engineering to design and execute experiments for route scouting, process optimization, scale-up, and technology transfer activities.

Provide analytical support and expertise to troubleshoot process-related issues and implement corrective actions.

IPC method development for non-GMP/GMP steps and research development routes.

Off-line support for Process Analytical Technology (PAT) methods (ex. HPLC calibration of methods).

Method development support for innovation and technology team.

HPLC method development that offers identification, and quantification of compounds in complex mixtures for high throughput experimentation (H.T.E.).

Preliminary identification of process impurities by Mass Spec (MS).

Residual solvent analysis.

Fit for purpose, genotoxic impurity method development for investigational routes.

Analyze and interpret analytical data to assess process performance, identify trends, and make data-driven decisions to improve process efficiency and product quality.

Generate technical reports and presentations to communicate findings to internal stakeholders.

Stay updated on emerging trends and advancements in analytical chemistry, and process optimization methodologies. Identify opportunities for continuous improvement in analytical techniques, processes, and systems.

Technology advancement work cross-functionally to ensure continued innovation for the PA team.

Platform consolidation of analytical data so that chemists and engineers can easily access data, accelerate processing time, and integrate results.

Contribute significantly to complex/multiple projects or functional areas through leading or influencing others.

Influence and support initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.

Ensure a productive and development-rich environment; provide training/mentoring for junior staff.

Define more complex/novel approaches and methodologies to solving complex technical challenges.

Proactively identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.

Qualification

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CMC Pharmaceutical DevelopmentContract FacilitiesAnalytical ChemistryOrganic ChemistryReaction KineticsCollaborationTeamworkData Platforms

Required

Bachelor's degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years relevant industry experience.

Master's 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.

Previous experience with the use of contract facilities desired.

Experience in working in a multi-disciplinary team environment.

Strong background in analytical chemistry or organic chemistry, and reaction kinetics is essential, along with the ability to work collaboratively with cross-functional teams to ensure the successful development of synthetic drug substance processes.