Senior Manager, Development and Design Transfer

US - TX - Austinfull timeOn Site

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senior

$143k–$179k

H1B: yes

Natera Senior Manager, Development and Design Transfer at Natera leads and coordinates transfer of products from R&D to Operations for NGS IVD/PMA assays. This role manages a team of scientists, ensures regulatory compliance, and drives design transfer activities and process validations.

Responsibilities

Plan and manage activities and studies from late-stage development to launch
Contribute to design documents including reagent stability plans, design inputs, outputs, verification protocols and reports
Participate in risk management activities such as hazard analysis and FMEA
Align with bioinformatics/statistics groups on study designs and acceptance criteria
Develop and execute detailed design transfer plans
Lead and coordinate design transfer activities from R&D to manufacturing
Lead test method development, characterization, and validation
Conduct studies to generate specifications and set process/test method specifications
Lead process validations, including single-site oncology assay validations
Ensure experimental quality using DOE, Cpk analysis, and Gage R&R
Lead cross-functional efforts to establish supply chain for raw materials and consumables
Ensure compliance with FDA, ISO 13485, and quality system regulations

Qualification

KNOWLEDGEAbility to establish and follow SOPsExperience authoring study plansProficiency in experimental design

Required

Advanced degree in molecular biology or related discipline. PhD is preferred, Master’s or Bachelors with equivalent industry experience considered
6-8 years of post PhD biotech industry experience or >10 years of post BS/MS biotech experience
At least 4 years managing a team of scientists and research associates
KNOWLEDGE, SKILLS, AND ABILITIES:
Must have hands-on experience with next-generation sequencing (NGS) and DNA/RNA molecular biology
Proven track record of successful design transfer for assays and medical devices
Strong understanding of assay development, design control, analytical validation, and manufacturing workflows
Extensive knowledge of quality and regulatory standards (ISO, CLSI, FDA)
Ability to establish and follow SOPs, with in-depth knowledge of GLP/GMP guidelines
Experience authoring study plans, protocols, and study reports is highly desirable
Experience with process validations for single-site oncology assays
Proficiency in experimental design, statistical data analysis, and technical problem-solving