Associate Product Development Scientist

Lancesoft; Martinez (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

LanceSoft is seeking a detail‑oriented R&D Support Associate to facilitate product development projects, review design outputs, and assist with technical documentation across the Product Development Life Cycle from R&D to Marketing.

The role requires a bachelor’s degree in a scientific or technical field, 0–3 years of related experience, and knowledge of IVD development, Design Controls, and GMP practices. Collaboration across cross‑functional teams is essential.

Qualifications

• Bachelor's degree in a scientific or technical field.
• 0–3 years of related R&D experience or training.
• Understanding of IVD development.
• Knowledge of Design Controls and Quality System Regulations.
• Familiarity with ISO 13485, IVDR, and MDSAP requirements.
• Strong verbal and written communication skills.
• Ability to effectively communicate and present complex information.

Responsibilities

• Facilitate and support product development projects.
• Draft design outputs for review by Product Design management.
• Assist with technical document review, including test records, data sheets, product labeling, SOPs, and design-output documentation.
• Edit product data sheets and assist with revisions to departmental procedures.
• Revise documentation associated with product implementations and discontinuations.
• Participate in routine laboratory activities, including preparation of purchase requisitions and ordering laboratory supplies.
• Monitor new reagent products through the Product Development Life Cycle across R&D, Manufacturing, QC, QA, and Marketing.
• Identify potential obstacles affecting product development timelines and coordinate with cross-functional teams.
• Support GMP-compliant product development activities.
• Organize test results and assist with drafting, proofreading, scanning, and preparation of product-development documentation.
• Assist with oversight of antibody raw material inventory within R&D.

Skills

Verbal communication

Written communication

Presentation skills

Education

Bachelor's degree in a scientific or technical field

Job description

Enter Job Description... Facilitate and support product development projects. Draft design outputs for review by Product Design management. Assist with technical document review, including test records, data sheets, product labeling, SOPs, and design-output documentation. Edit product data sheets and assist with revisions to departmental procedures. Revise documentation associated with product implementations and discontinuations. Participate in routine laboratory activities, including preparation of purchase requisitions and ordering laboratory supplies. Monitor new reagent products through the Product Development Life Cycle (PDLC) across R&D, Manufacturing, QC, QA, and Marketing. Identify potential obstacles affecting product development timelines and coordinate with cross-functional teams. Support GMP-compliant product development activities. Organize test results and assist with drafting, proofreading, scanning, and preparation of product-development documentation. Assist with oversight of antibody raw material inventory within R&D.

Required Qualifications

• Bachelor s degree in a scientific or technical field.
• (Manager will accept Associates as the least) 0 3 years of related R&D experience or training.
• Understanding of IVD development.
• Knowledge of Design Controls and Quality System Regulations.
• Familiarity with ISO 13485, IVDR, and MDSAP requirements.
• Strong verbal and written communication skills.
• Ability to effectively communicate and present complex information.

Preferred Skills

• Product development experience within an IVD, biotechnology, or regulated laboratory environment.
• Familiarity with GMP requirements.
• Experience with technical documentation and document control.
• Ability to work cross-functionally with R&D, Manufacturing, QC, QA, and Marketing.
• Strong attention to detail and organizational skills.

EEO

Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.