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Full-Time

Associate Principal Scientist

Engineering

Confirmed live in the last 24 hours

MSD

MSD

Compensation Overview

$135.5k - $213.4kAnnually

Senior

No H1B Sponsorship

North Wales, PA, USA + 1 more

More locations: Linden, NJ, USA

Hybrid work model requiring three days in the office per week, Monday - Thursday.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Required Skills
Agile
Requirements
  • Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of relevant experience; OR
  • Master of Science (M.S.) degree in chemical engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six (6) years of relevant experience; OR
  • Ph.D. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with three (3) years of relevant experience
Responsibilities
  • Technical guidance and oversight of late-stage product and process development.
  • Manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
  • Develops a robust and scalable manufacturing processes while minimizing time to regulatory filing and product launch.
  • Develops a process and product development plan. Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.
  • Drives the design and execution of process characterization activities. Ensures fit-for-purpose scale-down models are developed and employed. Oversees lab studies as required to ensure ‘right first time’.
  • Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and/or difficult issues.
  • Responsible for commercial site technology transfer and facility fit. Responsible for the DP control strategy, including the recommendation of process parameters, performance parameters, operating ranges, in-process controls, and parameter classification.
  • Influences primary packaging decisions. Drives and influences process demonstration and qualification (PPQ) strategy.
  • Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy (including filing storyboard) and filing readiness and supports preparations for agency meetings. Authors and review regulatory filings.
  • Establishes and validates platform engineering and scientific models for sterile product and process commercialization.
  • Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Monitors performance and recommends schedule changes, cost adjustments or resource additions.
  • Provides a regular summary of progress against development plan, key program and technical risks and risk level, mitigation strategies, and how success will be determined.
  • Serves on cross functional teams and support strategic initiatives.
  • Leads agile implementation of new/improved business processes in partnership with colleagues in Research Laboratories and the Manufacturing Division.
  • Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations.
  • Provides mentorship, technical oversight, and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues.
  • Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity, and inclusion.
  • Potentially manages a small group of individual contributors (professional and contract employees).

Company Stage

N/A

Total Funding

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Headquarters

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Founded

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