Process Development Scientist

Posted 4 Days Ago
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Juncos
In-Office
Mid level
Biotech • Pharmaceutical
The Role
The Process Development Scientist designs and executes scientific experiments, develops processes, ensures compliance, analyzes data, and supports digital transformation initiatives.
Summary Generated by Built In

The Scientist is responsible for conceiving, designing, executing, and interpreting scientific experiments that support project objectives with general guidance from the supervisor. This role develops robust scientific processes, ensures regulatory compliance, drives data-driven decisions, and contributes to digital transformation initiatives through advanced analytics.

Key Responsibilities

  • Conceive, design, execute, evaluate, and interpret experimental strategies that align with project goals.
  • Develop and implement new or innovative scientific protocols to address complex challenges.
  • Ensure all studies are conducted in compliance with approved protocols, cGMP, and regulatory requirements.
  • Provide detailed analysis, interpretation, and assessment of experimental data.
  • Maintain expertise in scientific disciplines, literature, and emerging technologies; share relevant insights with the team.
  • Introduce advanced scientific methods and tools when appropriate.
  • Integrate, clean, and analyze complex datasets from various digital systems (e.g., PAT, LIMS, MES, PI systems).
  • Apply multivariate statistics, predictive modeling, and advanced analytics to optimize processes.
  • Utilize modern data platforms and tools to support digital transformation.
  • Translate analytical and scientific insights into actionable recommendations for technical and business teams.
  • Collaborate effectively with scientific, engineering, operations, and business teams.
  • Represent the department on project teams under the guidance of senior staff.
  • Initiate collaborations within or outside the department or organization.
  • Provide guidance in experimental design, troubleshooting, and data interpretation.
  • Participate in scientific communities, committees, safety initiatives, or recruiting efforts.
  • May develop supervisory or mentoring skills over time.
  • Independently author scientific reports, summaries, protocols, regulatory documents, and invention disclosures.
  • Maintain organized timelines and ensure deliverables are completed according to project schedules.
  • Ensure laboratory and analytical practices adhere to cGMP and internal quality standards.

Core Competencies & Skills

  • Advanced scientific analysis, troubleshooting, and laboratory techniques.
  • Strong knowledge of cGMP and regulated environments.
  • Excellent organizational, multitasking, and cross-functional collaboration abilities.
  • Exceptional verbal and written communication, including technical writing.
  • Strong analytical reasoning and project management skills.
  • Ability to lead, motivate, and support others as needed.
  • Adaptability with proven ability to manage change.
  • Proficiency in Word, Excel, and PowerPoint.
  • Creativity in experimental design and data interpretation.
  • Fully bilingual in English and Spanish.

Requirements

Education & Experience

  • Doctorate OR
  • Masters + 2 years of Scientific experience OR
  • Bachelors + 4 years of Scientific experience.

Preferred experience:

  • Provide direct support to the requirement, design, and characterization of inspection/packaging process, process optimization strategies and/or troubleshooting of operational issues in the operations.
  • Apply advanced and diverse engineering principles to the design and implementation of system, equipment or process modifications, experiments, process and/or capital projects.
  • Develop, organize, analyze and present interpretation of results for operational issues or engineering projects.

Requirements:

  • Provide advanced technical support to AML-1 automatic packaging equipment and processes.
  • Strong Knowledge on Vision system technologies.
  • Strong Knowledge with local process flow, layouts and general packaging SOP’s to be able to define details of serialization solution.
  • Support troubleshooting, investigations, root cause analysis related to the packaging area and inspection process.
  • Technical Reports Development.
  • Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies.
  • Risk assessments and QRAES knowledge, to support risk assessments activities.
  • Project execution activities coordination (Material requests, Trainings, Production Windows, Work Orders generation)

Benefits
  • Administrative Shift
  • 7-months contract with possible extension

Top Skills

Excel
Lims
Mes
Pat
Pi Systems
PowerPoint
Word
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The Company
HQ: Cambridge, MASSACHUSETTS
39 Employees
Year Founded: 2010

What We Do

BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results.

Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields.

We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions.

BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.

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