Employment
Machaon Diagnostics compensation and benefits:
- Competitive salary
- 8 paid company holidays
- Paid vacation and sick days
- Comprehensive health and welfare benefits package
- Employee share purchase plan
- 401(k) retirement savings plan with matching employer contribution
- Employee referral bonus
- Relocation assistance, available for certain roles
- Training and development opportunities
- Workplace perks such as snacks and coffee, and flexible work schedules
Openings:
Job Title:
Clinical Research Project Manager
A Clinical Research Project Manager is in charge of coordinating study-related activities with Clinical lab, R&D, Business Development, Administration, and Quality Assurance teams. In this role project manager will use project-specific project planners and OKRs to manage study scope and timelines to ensure the overall growth and productivity of the Clinical research team.
The clinical Trials Project Manager is responsible for:
1. Management of incoming Request for Proposals (RFPs). Coordinate quote submission and contract execution.
2. Logging and tracking project scope and timelines.
3. Work with team leads to create project planners, short-term project milestones and manage deliverables.
4. Manage Audit schedules, deliverables
5. Schedule, Manage clinical research team calendars
6. Creation and Management of team OKRs
Minimum Position Requirements:
• Education: BA or BS with a minimum of 5 years of project management experience or MS with 3 years of project management experience or PG diploma in Clinical Trials Project Management with 2 years of Project Management experience.
• Desirable Experience: (a) A minimum of 2 years of project management experience in CRO or Pharmaceutical company, clinical research operations team.
• Knowledge: Must be knowledgeable regarding general laboratory practice and health and safety protocol.
• Special Skills/Equipment: Must be adaptable to the fast-paced work environment. Must have the mathematical ability, scientific background, and be able to recognize problems and troubleshoot appropriately. Must be able to collaborate with multiple teams. Must be able to communicate clearly and effectively in person and over the phone.
Please send cover letter and resume to Delanda@Machaondiagnostics.com
Job Title: Research Laboratory Scientist
Company:
Machaon Diagnostics Inc is an independent Clinical Reference Laboratory and CRO founded 18 years ago in Oakland, California. We specialize in coagulation and thrombosis, complement-mediated diseases, and rare disease genetics. Our mission at Machaon is to save more lives with lab testing. The laboratory is located on a hospital campus in the sunny San Francisco East Bay.
Job Responsibilities:
- Develop, validate and implement genetic, cellular and biochemical assays (e.g., ELISA, clot assays, light transmittance assays, flow cytometry, RT-PCR).
- Write validation reports, SOPs, reports for sponsor clients, IRBs, and FDA review.
- Demonstrate high-level problem-solving skills and analytical abilities to successfully perform laboratory testing.
- Maintain expertise in or knowledge of molecular and cellular biological techniques.
- Adhere to established laboratory policies in areas of procedures, quality control, quality assurance, and safety and compliance.
- Additional duties as assigned.
Experience Requirements:
- Strong background in molecular and cellular biological techniques and demonstrated ability to perform bench work.
- Must have excellent written and oral communication skills.
- Strong analytical and organizational skills.
- Must work effectively with an interdisciplinary team of scientists, physicians, lab technologists, quality assurance specialists, and client services team.
- Must demonstrate a high degree of professionalism, integrity, enthusiasm and initiative on a daily basis. Must have ability to work in fast-paced environment and be solutions-oriented.
- Attention to detail is critical: assay results will change clinical management of critically-ill patients!
Education Requirements:
- PhD or MS in immunology, chemistry, biochemistry, molecular and cell biology or other biological science field.
To Apply:
Please send CV, cover letter and references to James Kain, PhD. (james.kain @ machaondiagnostics.com).
Job Title: Clinical Laboratory Scientist (CLS) Part-time, Full-time and Weekend shifts available, 9am-5pm
We are searching for clinical laboratory scientists (CLSs) to join Machaon Diagnostics’ Louisiana Coagulation for a unique opportunity. We are looking for a CLSs to fill a full-time or part-time position. You will be working in a state-of-the-art clinical laboratory that is internationally recognized for its expertise in coagulation, platelets, rare disease and genetic testing. The position involves the performance of various test types, which may include coagulation assays, platelet aggregation, ELISAs and others. We expect to train the hired candidate in all of these testing techniques.
Candidates with science degrees (chemistry, biochemistry, molecular and cell biology, medical technology, CLS, etc.) AND a current MLS or CLS board certification are welcome to apply.
Compensation is competitive and verified annually against current CLS rates offered in the region. Benefits include health, dental, vision insurance, 401K, profit sharing, paid time off, flex hours and other benefits, like an endless supply of gourmet coffee.
Machaon is a fun, fast-paced and challenging environment that delivers specialized clinical reference lab testing services to doctors and hospitals across the US. We also conduct contract research/ clinical trials for the pharmaceutical and biotech industries, making the workload fun and dynamic. Machaon Diagnostics was founded in 2003 by a team of CLSs and we invite you to learn from our creative and scientific approach to improving healthcare one disease at a time.
Our clients include the largest reference labs, major academic medical centers, pharmaceutical firms, biotech companies, and others.
This job is for the select few serious candidates that are positive, high-energy, uniquely detail-oriented and meticulous in QA/QC record keeping.
Your duties will include work in the following areas:
• Coagulation testing
• Platelet aggregation
• Stago Analyzers
• ELISA
• Test validation
• Lab assistant management
Please send your resume and references when applying for this position.
Machaon Diagnostics is an 18-year-old laboratory firm that is accredited by the College of American Pathologists (CAP), accredited by CLIA and licensed by multiple states. We are experts in hemostasis, thrombosis, immunology, special chemistry, platelet physiology/function, molecular diagnostics, and genetic assays.
The laboratory is located on Oak Street, in a fun neighborhood and just down the street from Ochsner Medical Center in New Orleans.
Please send CV, cover letter and references to Delanda@Machaondiagnostics.com.
Job Title: Quality Assurance Associate
Compensation: Competitive, Exempt
Employment Type: Full-Time, 9am-5pm (M-F)
Position Summary:
We are currently looking to hire a quality-driven individual with experience in the regulated environments of either the diagnostic laboratory, biotechnology industry, pharmaceutical industry, or clinical research trials environment(s). As a Quality Assurance Associate, you would be responsible for activities that support and continue to improve our foundational Quality Management program.
This unique opportunity would require familiarity with execution of day-to-day laboratory quality assurance tasks as well as provide the opportunity for oversight of longer-term quality assurance projects and initiatives within the team. Identification and implementation of continuous process-improvement activities is key to bringing our fast-growing operations to the next level. We are a dedicated team of individuals that nurture a culture of quality, value a growth-mindset, and enjoy taking on challenges with positivity and an appreciation for innovation and creativity while always striving for excellence.
The Quality Assurance Associate is responsible for performing and participating in activities and initiatives related to the support and maintenance our operational Quality Management program which is the framework for regulatory compliance within all of our working systems. The Quality Assurance Associate is expected to monitor and report on the existing quality systems utilized as well as identify and implement continuous quality process improvements to support our continued growth in the industry.
Main Responsibilities:
- Draft, approve, and review all manner of controlled documents such as standard operating procedures, policies, job-aids and forms
- Manage the review and development of key quality documentation such as: document control, non-conforming events & preventive and corrective action plans, audit and inspection reports, equipment qualification, training and competency programs, test method validations, preventive maintenance schedules, environmental-monitoring
- Establish and perform ongoing inspection-readiness activities
- Interpret, implement, and inspect for compliance with the internal quality management program and corresponding industry standards and regulations: FDA, CAP, CLIA, GLP, GCP, GCLP, GMP, HIPAA, GDPR, CLSI, ISO
- Manage the recording, tracking, and reporting of key quality metrics
- Participate in regular audits and inspections; both internal and external
- Maintain activities related to non-conforming event reporting and assist in performance of root-cause analysis and identifying corrective and preventive action plans
- Provide ongoing educational opportunities and/or training sessions for all staff in support of maintaining a culture of quality
- Identify and implement continuous process improvements
- Assist with other special projects, as assigned
Minimum Position Requirements:
Education: BS/MS in Clinical Laboratory Science, or PhD in Biology or related sciences
Desirable Experience: CLS (BS/MS) with 3-5 years of experience or PhD with 2+ years of experience in a quality or regulatory role in either a diagnostic laboratory, biotech/medical device field, clinical research and/or clinical trials environment(s).
Knowledge: Must be knowledgeable and familiar with clinical laboratory and/or clinical research industries and the corresponding regulatory standards and requirements. Must have direct experience with activities related to quality management program initiatives in a highly regulated environment.
Special Skills/Equipment: CLS/MLS certification is highly desired, but is not a requirement. Must possess a keen attention to technical and regulatory detail, an intrinsic desire and commitment to quality improvement, strong analytical ability, and a command of the English language; both verbal and written. A scientific background with experience recognizing systemic non-compliance and implementing long-term solutions is highly desired. This role is best suited for someone highly organized, articulate, systematic, and adept at managing multiple projects at once in a fast-paced environment with rigorous deadlines.
Physical Requirements: Office environment with the ability to remain in a stationary position, often standing or sitting for prolonged periods of time.
Working Relationships/Contacts: The incumbent will work directly with the Quality Assurance Manager, Clinical Research Associates, Clinical Research Scientists, Laboratory Assistants, Clinical Laboratory Scientists, PhD’s, MD’s and other department Supervisors, Managers, and Directors.
Uniform Requirements: Appropriate professional attire.
Days/Hours: Monday-Friday, 9:00AM-5:30PM. Work hours/variable shifts are negotiable.
To apply, please send a cover letter and a copy of your resume to: Delanda@Machaondiagnostics.com
Position Title: Quality Assurance Specialist; CRO
Reports To: Quality Assurance Manager
Position Summary:
The Quality Assurance Specialist; CRO is responsible for performing and managing all activities and initiatives related to the rare disease Clinical Research Operations (CRO) that ensure compliance with laboratory industry regulations and adherence to the quality management program. The Quality Assurance Specialist ; CRO is expected to monitor and manage the existing quality systems as well as identify and implement continuous process improvements for the department.
Main Responsibilities:
- Draft, approve, and review controlled documents such as standard operating procedures, policies, job-aids and forms
- Manage the development and review of key documentation such as: Study Plan Agreements, Clinical Research Protocols, IRB-related documentation, Clinical Study Reports, Training documentation, and data submission to research sponsors
- Perform and establish ongoing inspection-readiness activities
- Interpret, implement, and inspect for compliance with the internal quality management program and corresponding industry standards and regulations: FDA, CAP, CLIA, GLP, GCP, GCLP, GMP, HIPAA, GDPR
- Manage the recording, tracking, and reporting of key quality metrics
- Participate in regular audits and inspections; both internal and external
- Maintain activities related to non-conforming event reporting and assist in performance of root-cause analysis and identifying corrective and preventive action plans
- Provide ongoing educational opportunities and/or training sessions for all staff in support of maintaining a culture of quality
- Identify and implement continuous process improvements
- Assist with other special projects, as assigned
Minimum Position Requirements:
Education: BS/MS in Clinical Laboratory Science, or PhD in Biology or related sciences
Desirable Experience: CLS (BS/MS) with 3-5 years of experience or PhD with 2+ years of experience in a quality or regulatory role in either a diagnostic laboratory, biotech/medical device field, clinical research and/or clinical trials environment(s).
Knowledge: Must be knowledgeable and familiar with clinical laboratory and/or clinical research industries and the corresponding regulatory standards and requirements. Must have direct experience with activities related to quality management program initiatives in a highly regulated environment.
Special Skills/Equipment: CLS/MLS certification is highly desired, but is not a requirement. Must possess a keen attention to technical and regulatory detail, an intrinsic desire and commitment to quality improvement, strong analytical ability, and a command of the English language; both verbal and written. A scientific background with experience recognizing systemic non-compliance and implementing long-term solutions is highly desired. This role is best suited for someone highly organized, articulate, systematic, and adept at managing multiple projects at once in a fast-paced environment with rigorous deadlines.
Physical Requirements: Office environment with the ability to remain in a stationary position, often standing or sitting for prolonged periods of time.
Working Relationships/Contacts: The incumbent will work directly with the Quality Assurance Manager, Clinical Research Associates, Clinical Research Scientists, Laboratory Assistants, Clinical Laboratory Scientists, PhD’s, MD’s and other department Supervisors, Managers, and Directors.
Uniform Requirements: Appropriate professional attire.
Days/Hours: Monday-Friday, 9:00AM-5:30PM. Work hours/variable shifts are negotiable.
To apply, please send a cover letter and a copy of your resume to: Delanda@Machaondiagnostics.com
Title: Clinical Laboratory Assistant
Machaon Diagnostics is a clinical reference laboratory, specializing in the diagnosis, treatment and monitoring of hemostatic and thrombotic conditions. We are looking for a passionate, intellectually hungry, recent college graduate interested in gaining clinical laboratory, contract research, and clinical trial experience to fill our laboratory assistant job opening. Past laboratory assistants have had the opportunity to attend scientific conferences, followed by matriculation into CLS, MD, PharmD and other allied health graduate programs.
Job Details: Demonstrate proficiency and understanding of standard clinical laboratory practices. Review requisitions, orders tests and processes specimens in preparation for laboratory procedures. Perform general laboratory maintenance tasks including preparing reagents, re-stocking consumables and washing glassware. Assist with quality control and quality assurance paperwork. Assist with clinical trials including completion of Institutional Review Board documentation, subject recruitment, screening, and management, and performance of research related testing. Design and revise forms and protocols. Adhere to Machaon policies and procedures as directed by the supervisor, manager or medical director. Interact with patients, subjects, visitors, physicians, and coworkers in a professional and courteous manner.
Qualifications:
-B.A./B.S with coursework in chemistry, biochemistry, immunology, molecular biology,
statistics and related subjects required.
-6 months or more related experience preferred.
-Strong organizational skills
-Strong communication skills
-Proficiency in MS Excel, including statistical applications
-Must reside locally
Please send resume and cover letter via e-mail to: connie.ng@machaondiagnostics.com
Machaon Diagnostics is California’s only independent bleeding and clotting laboratory, located in Oakland on the Summit Campus of Alta Bates Summit Medical Center. Machaon Diagnostics is a CA-licensed, CLIA-accredited, CAP-accredited clinical
laboratory approved to provide high-complexity clinical lab testing services.
Position Title: Senior Clinical Associate with Phlebotomy
Reports To: Clinical Research Director
Position Summary:
The Senior Clinical Research Associate will participate in functions of both the clinical laboratory and clinical research at Machaon Diagnostics, and will report to the Director of Clinical Research and the Technical Supervisor.
Responsibilities:
Senior Clinical Research Associate is responsible for:
- Assisting in management of clinical trials and overseeing the smooth operation of clinical studies. Logging and tracking project scope and timelines.
- Preparing study materials such as study plans, IRB proposals, subject facing documents and deliverables. The role also includes engaging with research participants and sponsors, troubleshooting, informing study subjects details of the study, implementing informed consent, and liaising with sponsors or clinical research consultants to communicate needs to all involved in such studies.
- Assisting with data collection and management, presentation of findings and preparation of study reports.
- Assisting with regulatory compliance tasks and maintaining audit preparedness through revision and preparation of documents and forms. This includes assisting in preparing and editing validation materials for both clinical and research assays.
- Performance of low to moderate complexity assays under the supervision of licensed Clinical Laboratory Scientists (CLS) and Senior Research Scientists and statistical analysis of results may be required.
- Administrative support of CLS’ and technical supervisors, including but not limited to data management and organization, liaising with physicians and clinical laboratory clients, assisting with policy implementation, execution of good documentation policy practices, creating documents and forms, and quality assurance review of clinical laboratory material.
- Other special projects as needed.
Minimum Position Requirements:
• Education: BA or BS with minimum of 2 years of laboratory experience and clinical research experience.
• Desirable Experience: (a) CA Certified Phlebotomy Technician (CPT-1) License, this role includes the collection of clinical and clinical research blood specimen via venipuncture, proper identification of individuals, labeling samples and processing samples for further clinical laboratory or research testing.
• Knowledge: Must be knowledgeable regarding general laboratory practice and health and safety protocol.
• Special Skills/Equipment: Must be adaptable to fast-paced work environment. Must have mathematical ability, scientific background and be able to recognize problems and troubleshoot appropriately. Must be able to collaborate with multiple teams. Must be able to communicate clearly and effectively in person and over the phone.
Physical Requirements: Mobility is required. Must be able to work in a laboratory environment with infectious, toxic and radioactive substances following OSHA regulations and laboratory protocols.
Working Relationships/Contacts:
The incumbent works directly with Director of Clinical Research, other Testing Personnel, the Technical Supervisor, Laboratory Manager, Laboratory Director, Medical Director, Clinical Research Associates, Laboratory Assistants and Clerical staff.
Uniform Requirements:
Appropriate professional attire, plus a clean lab coat and gloves and other personal protective equipment, as needed.
Days/Hours: Monday-Friday, 9:00AM-5:30PM. Overtime may be required.
To apply, please send a cover letter and a copy of your resume to: Delanda@Machaondiagnostics.com