Process Development Scientist

Ultimate Solutions

$70K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Doctorate degree or Master's with 2 years of scientific experience or Bachelor's with 4 years of scientific experience.
  • Experience in regulated industry is essential.
  • Proven ability to create and execute validation and qualification documentation.
  • Strong communication skills, especially with suppliers and across locations.
  • Familiarity with automated vision inspection systems is a plus.
  • Knowledge of Computer System Validation (CSV) and related documentation is beneficial.

Responsibilities

  • Conceive, design, and execute experimental strategies.
  • Provide input for new processes to ensure robust and reliable data.
  • Ensure compliance with protocols, guidelines, and regulations during studies.
  • Monitor field expertise and communicate relevant observations.
  • Develop and implement new protocols for specific challenges.
  • Independently author complex scientific and regulatory documents.
  • Engage with the external scientific community for collaboration and insights.

Benefits

  • Innovative and stimulating work environment.
  • Opportunities for collaboration across departments.
  • Possible advancement into leadership or mentoring roles.
  • Participation in cutting-edge scientific research.
  • Involvement in external scientific community activities.
Full Job Description
DESCRIPTION
The Process Development Scientist conceives, designs, implements and executes specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.

RESPONSIBILITIES
  • Conceives and designs, executes or evaluates, and interprets experimental strategies.
  • Provides input to new processes to generate robust and reliable data.
  • Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
  • Designs, monitors or conducts experimental strategies with general guidance from supervisor.
  • Provides data analysis and interpretation, and assesses impact of the data on the project.
  • Keeps current in field of scientific expertise and areas relevant to their function.
  • Monitors field of expertise, including literature and technology development, and communicates relevant observations.
  • May introduce advanced scientific methods.
  • Develops and implements new and novel protocols to address specific issues.
  • May represent the department on project teams under supervision of a senior scientific staff member.
  • May initiate productive collaborations within and outside of the department or company.
  • Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
  • Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
  • Participates in external scientific community.
  • May assume lead role in department-wide support efforts such as safety, recruiting and committees.
  • May develop supervisory and mentoring skills.
  • Develops and follows timelines for completing project team work.
EDUCATION
  • Doctorate OR
  • Master + 2 years of Scientific experience OR
  • -Bachelors + 4 years of Scientific experience.


REQUIREMENTS
  • Experience in Regulated Industry
  • Proficient in creating and executing validation and qualification documentation
  • Provide support to vision inspection qualification and characterizations
  • Requires excellent communication skills with suppliers and other sites
  • A Plus: Knowledge in automated vision inspection systems
  • A Plus: Knowledgeable in CSV. Support CQV documentation and execution
    Other Considerations:
  • Willing to work during regular business hours, night shift, and/or weekends, as needed to meet the projects' schedule.
Employment visa sponsorship is not available.
Not open for Corp-to-Corp arrangements.

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