Mercy BioAnalytics, Inc. is a pre-commercial biotechnology company committed to reducing suffering and saving lives through the early detection of cancer. We are looking for a passionate individual to join our mission to enable development of the Mercy Halo test. This high visibility position is an excellent opportunity for individuals seeking a scientific leadership opportunity in early detection of cancer.
Candidates for this position must enjoy working for a fast-paced, cutting-edge company and demonstrate exemplary technical capabilities and a passion for contributing to our life-saving mission.
Responsibilities
- Lead Mercy’s Development team; recruit, hire, and support ongoing professional growth and development of team members.
- Plan, prioritize, and assign allocation of the Development team and ensure deliverables, timelines, specifications, and budgets are met.
- Write Assay Development, Verification and Validation plans. Write protocols and coordinate execution and report generation.
- Establish project plans and product launch timelines in collaboration with research, manufacturing, and marketing teams.
- Design and execute guard-banding and stability studies to ensure robustness of the assays.
- Lead the development and qualification of analytical, orthogonal and functional methods for quantitative/qualitative assessment of raw materials, WIP, and finished goods.
- Lead technology transfer to internal and external manufacturing facilities, including requisite documentation.
- Write, implement, and validate SOPs and customer-facing documentation.
- Collaborate with Quality Assurance and the Portfolio Management Office to establish a PDP and process purpose built to meet global IVD regulatory requirements.
- Play a strong supporting role in development and maintenance of Quality System elements, specifically for Design Control.
- Represent Development on Product Core Teams; collaborate with Program Management to build bottom-up timelines; identify, communicate, and mitigate risks.
- Work with the Bioinformatics team to finalize assay-specific algorithms.
- Support development of regulatory filings.
- Collaborate on the development of strategic and operational plans and associated budgets.
- Work with the Marketing team to prioritize customer/market needs that become product design inputs.
- Collaborate with internal and external parties and routinely present experimental findings to internal and external parties and at meetings.
Requirements
- Ph.D. in Molecular Biology, Biochemistry, or other life science such as Immunology.
- ≥7years of leadership experience in life sciences Development; In Vitro Diagnostic product development experience required.
- Proven track record developing robust immunoassays; molecular biology and qPCR experience required; NGS experience is a plus.
- Demonstrated leadership in diagnostic development, protein analytics and assay optimization.
- Experience developing products within a 21 CFR part 820-compliant Quality Management System, including Design Control.
- Experience with establishment of robust reagent and assay development as well as manufacturing procedures.
- Effective communication, collaboration, and negotiation on a global stage.
- Track record for recruiting, retaining, and developing high-potential, high-performing, diverse talent.
- Ability to work effectively and efficiently in a fast-paced and dynamic environment and pay close attention to detail.
Hiring Manager: Chief Scientific Officer
Location: On-site