Clinical Development Scientist II

Organization: 
MolecularMD
Job Location: 
Portland, OR
Salary: 
DOE
Job Description: 

The Clinical Development Scientist II is responsible for development of new technologies/platforms and assays, performance of validation studies, transfer of assays and implementation into the clinical laboratory. The Clinical Development Scientist II will perform the functions of nucleic acid isolation, quantification, testing, data analysis, recording, and reporting laboratory results as directed for specific assays/projects performed in the Clinical Laboratory under CLIA. Responsibilities also include using fundamental concepts, practices, and procedures of the particular field of specialization to perform scientific research tasks requiring application of both established and innovative techniques and procedures. In addition, the Clinical Development Scientist II will serve as technical lead on IVD project teams when appropriate.

Essential Functions:
• Provides technical oversight of the project team with support and direction from the Clinical Assay Development Manager.
• Drafts project development or validation plans and associated budget estimates and timelines.
• Independently executes experiments according to approved project development or assay validation plans, budgets and timelines.
• Critically analyzes complex data and evaluates/integrates results with project objectives;
• Identifies and solves problems in experimental designs, providing clear documentation of the problem resolution process.
• Prepares written project progress reports, project summary reports or assay validation reports as directed.
• Serves as technical lead for designated development projects, coordinating product development, performance improvement, and assay transfer collaboratively with other departments.
• Participates in fundamental literature review related to products under development;
• Performs competitive audits and product evaluations as directed;
• Participates and provides input into:
- Discussions for design and development of new laboratory technologies, platforms, and applications, following MolecularMD design control procedures as appropriate;
- Defining the specification, design, and implementation phases of new laboratory system software;
- Root-cause analyses, communicating recommendations to resolve tech problems.
- Raises regulatory/compliance concerns to the Clinical Assay Development Manager, Director of Quality & Regulatory Affairs, or Quality Control/Assurance Specialist;
- Models compliance with clinical laboratory regulatory policies, all MolecularMD policies, and contractual procedures for each MolecularMD client;
- Demonstrates strict adherence to established laboratory processes across all phases of sample handling and testing workflows;
- Demonstrates commitment to compliance with all MolecularMD Clinical Laboratory procedures, safety and regulatory work practice guidelines as defined in the Quality Management Program, the Chemical Hygiene Plan, confidentiality and HIPAA agreements, and all applicable state and federal regulations and requirements.

Requirements: 

The requirements listed below are representative of the knowledge, skill, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to perform essential job duties with or without reasonable accommodation, and without posing a direct threat to the safety or health of employee or others.
• Bachelor of Science degree (B.S.), and six (6) plus years of relevant research experience or;
• Master of Science degree (M.S.), and three (3) plus years of relevant research experience or;
• Ph.D. and relevant research experience.
• A minimum of five (5) years of experience in clinical molecular diagnostics assay development is required.
• Must qualify as High-Complexity Testing Personnel per 42 CFR 493.1489.
• Must have experience developing assays under design controls in an FDA-regulated environment.

Contact Information: 

Applicants send cover letter and CV/Resume to:

human_resources@molecularmd.com

About Our Organization: 

The concept of MolecularMD grew out of a discussion with Oregon Health Science University (OHSU) clinical investigators, where the critical needs of chronic myelogenous leukemia (CML) patients were revealed. These patients often develop a wide range of genetic aberrations during the progression of their disease. Because of this, they require accurate and reliable molecular diagnosis to tailor their therapy and prolong their progression free survival.

MolecularMD provides innovative and reliable molecular diagnostics products and services to support clinical development, regulatory approval, and commercialization of targeted cancer therapies.
Together with our pharmaceutical clients, we aim to better understand the link between molecular response and improved survival. The Company’s ultimate goal is to become the leader in precise molecular assays for oncology and eventually, for all personalized medicine.

Here at MolecularMD, we value our people and we’re passionate about our work. Our core values consist of:

1. Teamwork and Partnership
2. Innovation
3. Competitive Commitment
4. Quality and Customer Focus
5. Leadership