Process Development Sr Scientist

Posted 7 Days Ago
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Juncos, PRI
In-Office
Senior level
Pharmaceutical
The Role
Leads pharmaceutical process development studies, experiments, validation protocols, process characterization, technology transfer, and technical investigations. Analyzes and interprets data, recommends project actions, develops experimental designs, introduces advanced technologies, prepares technical documentation, and contributes to project milestones. The role also supports collaboration, mentoring, safety initiatives, recruiting, and department-wide efforts in sterile drug product manufacturing and aseptic filling operations.
Summary Generated by Built In

 For Validation and Scientist Services in the Process Development area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry.
  • Bilingual (English & Spanish).
  • Project Management skills.
  • Shift: Administrative, and according to business needs.
  • Experience in:
    • Sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
    • Aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process.
    • Executing validation protocols, characterization studies, technical reports, investigations, and change controls.

The Personality Part:    

  • Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, and creative (for coming up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, ethical behavior, and the use of the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies.
  • Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations.
  • Expands knowledge-seeking beyond core area of expertise.
  • Identifies relevant external competitive knowledge.
  • Independently prepares new and novel protocols/experimental design.
  • Key contributor to an independent research/project team.
  • Initiates productive collaborations outside of the department or company.
  • Introduces new or advanced technologies and/or concepts.
  • May contribute to scientific journal articles or complex technical documents as lead author.
  • Leads department-wide support efforts such as safety, recruiting and committees. Develops supervisory and mentoring skills.
  • Makes proactive decisions that contribute to the achievement of milestones.
  • Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the next piece?

Skills Required

  • Bachelor's degree
  • Five years of experience as a Scientist within the pharmaceutical or regulated industry
  • Bilingual English and Spanish proficiency
  • Project management skills
  • Experience with sterile drug product manufacturing in the pharmaceutical or biotechnology industry
  • Experience with aseptic filling operations
  • Experience with process characterization
  • Experience with process validation and PPQ
  • Experience with technology transfer and commercial processes
  • Experience executing validation protocols and characterization studies
  • Experience preparing technical reports, investigations, and change controls
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
Year Founded: 2008

What We Do

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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