Senior Manager, Development and Design Transfer

POSITION SUMMARY:

We are seeking an experienced Senior Manager, Design Transfer to lead and coordinate the transfer of products from R&D into Operations. This role will plan, execute, implement, and document all design transfer activities for a next generation sequencing (NGS) IVD/PMA assay under Quality Systems Regulations and Design Control. The role will be managing a multidisciplinary group of scientists, providing technical mentorship, and ensuring timely delivery of project milestones. The manager also will ensure robust processes, documentation, compliance with regulatory requirements, and cross-functional alignment.

PRIMARY RESPONSIBILITIES:

Design Transfer Leadership

Responsible for planning and managing activities and studies from late-stage development to launch

Contribute to design documents, such as reagent stability plans, design inputs, design outputs, design verification protocols and reports while working closely with Quality and Regulatory partners

Routinely participate in risk management activities (such as hazard analysis, FMEA) to identify hazards and its causes and propose controls to mitigate risks

Works closely with bioinformatics / statistics groups in aligning with rationale for 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 based on statistical analysis

Lead process validations; experience with single-site oncology assay validations is required

Assure experimental quality through sound experimental design; utilize DOE, Cpk analysis, and Gage R&R, and mentor others in study design

Lead cross-functional efforts to establish supply chain for raw materials and consumables; propose and implement improvements

Ensure compliance with FDA, ISO 13485, and quality system regulations during design transfer and production

Communicates progress directly with colleagues and senior management

Team & People Management

Manages a team of scientists to coordinate the execution of studies to support development of QC methods, verification studies and validation of assays

Manage and provide leadership for scientists to ensure group effectiveness and development

Provide technical mentorship and decision-making support for the team

Monitor performance, deliver timely feedback, and support career development of direct reports

Foster a culture of accountability, safety, compliance, and continuous learning

Actively participate in the project core team and program team meetings, provide project updates to cross functional teams and senior leadership

Cross-Functional Collaboration

Partner with Operations, R&D, Product Management, Quality Assurance, and Regulatory Affairs to ensure seamless design transfer and product launch

Serve as the primary liaison between development and operations, ensuring knowledge transfer and training of operational staff

Incorporate operational feedback into design improvements and refinements

Contribute technical and process documentation to regulatory submissions

Actively participate in the project core team and program team meetings, provide project updates to cross functional teams and senior leadership

Documentation & Compliance

Oversee creation, review, and approval of SOPs, work instructions, and verification/validation protocols and reports

Ensure compliance with FDA, ISO, CLSI, and other international regulatory requirements, including GLP/GMP

Maintain audit-ready documentation for internal and external inspections

QUALIFICATIONS:

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

Demonstrated ability to lead multidisciplinary teams and provide mentorship to research associates and junior scientists

Strong project management and organizational skills

Excellent communication and presentation abilities, including reporting to senior leadership

Collaborative, adaptable, and focused on achieving business and corporate objectives

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Austin, TX

$143,100—$178,900 USD