Scientist

Duration: 12 months

Shift: Standard Day shift- Full-Time (40 hours/week)

Reports to: R&D Assay Development On-Market Support Team Lead

Position Summary:

• We are seeking a motivated and detail-oriented Scientist II (Senior Scientist equivalent) for a one-year temporary assignment within our R&D Assay Development On-Market Support team.
• This role is dedicated to supporting global regulatory submissions for our on-market products.
• The successful candidate will be responsible for project management, regulatory response coordination, and documentation strategy, contributing directly to the continued success of our product portfolio.

Key Responsibilities:

Regulatory Submission Support:

• Coordinate and deliver timely, informed responses to global regulatory authorities’ questions related to assay development and product performance.

• Collaborate cross-functionally with Regulatory Affairs, Quality, and R&D teams to gather and synthesize necessary information for submissions.

Project Management:

• Track and manage activities and deadlines related to regulatory submissions and post-market support projects.

• Maintain project timelines and communicate status updates to stakeholders.

Product Knowledge Repository:

• Establish and maintain a comprehensive repository of product knowledge, including technical documentation, study data, protocols, and regulatory correspondence.

• Ensure the repository is organized, accessible, and up to date for internal use.

Documentation Strategy:

• Assess current documentation and design history files for completeness and regulatory readiness.

• Make recommendations and develop strategic plans to address gaps, including proposing new study plans, protocols, and documentation updates.

• Partner with subject matter experts to drive documentation improvements and ensure compliance with global regulatory requirements.

Qualifications:

• PhD or MS in life sciences, chemistry, biochemistry, or related field (or equivalent experience).

• 3 years of experience in assay development, R&D, or related scientific role; experience in regulated environments preferred.

• Demonstrated experience supporting global regulatory submissions or working with regulatory authorities.

• Strong organizational and project management skills, with the ability to manage multiple deadlines and priorities.

• Excellent written and verbal communication skills.

• Ability to synthesize complex scientific information for a variety of audiences.

• Experience with documentation systems, design history files, and regulatory documentation standards.

• Proficiency in Microsoft Office and project management tools.

Preferred Qualifications:

• Previous experience in on-market support for medical devices, diagnostics, or related regulated products.

• Familiarity with global regulatory requirements (e.g., FDA, CE, PMDA).

• Experience in establishing knowledge repositories or databases.

General Summary of Duties and Responsibilities:

• Candidates should have experience working in a GMP environment.
• Plans and executes own experimental work
• Analyzes associated lines of investigation and devises and recommends methods to resolve problems
• Writes reports covering data and scientific explanation of results and conclusions
• Collaborates outside team on project related issues or studies

Qualifications:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the basic knowledge, skills, and or abilities required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Solid knowledge of molecular biology, chemistry, biochemistry or related disciplines
• Understanding of molecular diagnostic technology and nucleic acid amplification
• Understanding of scientific method experimental design and statistical analysis
• Ability to design both standard and factorial experiments process improvement
• Ability to analyze data and come to valid scientific conclusions,
• Ability to prepare and present studies to small groups of people
• Sound technical writing skills and ability to document technical work.
• Ability to communicate effectively with peers and management.
• Experience working in a GMP environment