Seranbio1mo ago

Principal Scientist, Development Project Lead

BendFull-time Exemptlead

OtherScientist Development Project

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Overview

The Principal Scientist,

Technical Tools

OtherScientist Development Project

The Principal Scientist, Development Project Lead will lead projects that scale up and define the processing space of oral solid pharmaceutical products as they advance into and through stage 1 of process validation. Success in this role also includes a smooth transfer of technical knowledge to the commercial operations team, participation in stage 2 process validation, and provision of ongoing support throughout the product lifecycle. The Principal Scientist will interface with different departments within the company to ensure project success and will serve as the technical point of contact for the project sponsors. The Principal Scientist is expected to integrate the efforts of experts across different technical areas into a cohesive project strategy. This role requires the individual to blend strong fundamental knowledge with practical, risk-based decision making to identify solutions that meet quality and schedule expectations for the project sponsors.

Achieves results with a high level of independence and uses judgement to solicit guidance

Leads technical aspects of projects, and may act as a subject matter expert to provide support and guidance for other projects

Develops broader technical strategy and specific experimental work plans

Performs and/or supervises experimental execution as appropriate to ensure quality of the results

Analyzes data, draws conclusions, and proposes next steps to meet project milestones

Authors and reviews technical reports and presentations

Interfaces with clients through verbal and written communications

Effectively communicates with internal stakeholders to manage project timelines and strategy

Adapts approach to evolving project requirements

Mentors, and may manage employees

Coordinates the work of other team members

Provides technical guidance and mentorship

May have direct reports and provide constructive and timely performance evaluations

Responsibilities may increase in scope to align with company initiatives 

Performs related duties as assigned

Demonstrated experience with pharmaceutical product and process development, including amorphous dispersions and oral solid dosage forms

Expertise with common unit operations for spray drying, blending, milling, granulation, compression, fluid bed coating, and encapsulation

Understanding of formulation concepts and material properties of common excipients

Demonstrated experience in process development activities that support process validation, and familiarity with appropriate regulatory expectations and industry practices

Demonstrated experience with transfer of manufacturing processes into GMP environments and / or process transfer between different manufacturing sites

Demonstrated experience with principles of risk-based decision making and common tools for risk analysis

Ability to apply rigorous scientific and engineering principles to guide practical decisions

Advanced laboratory and data analysis skills

Excellent verbal and written communication skills

Excellent time management skills, with an ability to prioritize and / or delegate tasks appropriately to meet deadlines

Excellent leadership and collaboration skills

Ability to function well in a high-paced and at times stressful environment

B.S. in Science or Engineering discipline with 10+ years of experience

M.S. in Science or Engineering discipline with 8+ years of experience

Ph.D. in Science or Engineering discipline with 3+ years of experience

Combination of degree and experience required, and:

3+ years of experience on projects where the key deliverables required GMP execution