Production Supervisors
Senior Regulatory Affairs Specialist
Project Managers
Lean / Black Belt
Validation Engineers
QA Supervisors

Quality Engineers
Associate Scientists
Scientist I
Scientist II
R&D Manager

Please Contact us with a word doc or pdf version of your updated CV or resume attached

* Shift Position Leader – 6:00 PM to 6:00 AM
* Protein Purification and Mammalian Cell Culture
* Strong Leadership Abilities

Qualifications: B.S. or M.S in engineering or relevant science field A Certified Quality Engineer/Certified Quality Auditor/Certified Lead ISO Auditor would be highly desirable

Requirements:

• Experience with new product development and manufacturing of medical devices
• In depth working knowledge of ISO 13485
• Track record of leading process validation teams and tasks
• Excellent knowledge of design control, document and change control, CAPA, internal audits, risk management, statistical techniques, and supplier quality
• Desirable experience includes:
  Experience with class II & III IVD kits & instruments
  IVD CE marking, 510K and PMA experience
  Six sigma (green or black belt), and a working knowledge of capability analysis

Competencies:

• Establish relationships with suppliers
• Comfortable with participating in regulatory inspections
• Excellent Communication skills both written and verbal
• Excellent inter-personal skills
• Comfortable dealing with details while still being able to see the wider picture
  
• Able to multitask and manage changing priorities to meet company needs
  
• Lead and encourage best practice and ensure all working practices adhere to the company standards and procedures
  
• Able to record and analyze data and prepare reports and presentations
• Able to identify continuous improvement opportunities based on sources of quality data
  
• Working knowledge of root cause analysis tools
• Able to be creative with a risk-based approach while assuring full compliance
• Excellent team worker, with skills in raising awareness of quality within an organization and supporting colleagues in related activities
• Experience of working with multi-disciplined teams and external contacts to achieve Company objectives and deadline

The Associate Scientist will assist in the design, development, and execution of the research and development of molecular diagnostic projects as well as participate in the transfer of new molecular products to Manufacturing and Quality Control. Associate Scientists are expected to work under design control guidelines and must understand Design Control, ISO, and QSR as it relates to the development and commercial introduction of new products to the market.

Duties:

• Undergo QSR, JMP, DOE and BSL2 training
• Demonstrate a high level of initiative in performing experiments, particularly in troubleshooting assay development issues
• Demonstrate a high level of initiative in performing experiments, particularly in troubleshooting assay development issues
• Perform various experiments as required for the verification and validation of the ML instrument and related molecular assays.  These include, but are not limited to, real-time RT-PCR amplification, DNA/RNA extraction, plasmid isolation, DNA cloning and sequencing, documentation, maintenance of cell lines, working in a BSL2 and class 10,000 clean room environment, handling and testing of clinical specimens, data analysis, creation of control material and contrived samples.
• Assist senior scientists in the planning and execution of experiments.
• Work with QA/RA to co-author GMP/QSR documents related to product manufacturing, quality assurance and CAPA.
• Write clear and understandable publications, SOP's, MSDS, work instructions, pack inserts, reports, and technical summaries as needed
• Participate in the preparation of 510(k) and other FDA submissions.
• Participate in and adhere to the Quality Program as defined by the QSR especially as it pertains to Design Control.
• Perform routine laboratory duties as needed such as maintaining inventory and supplies to ensure uninterrupted research.  Participate in setting up the laboratory and in ordering both reagents and equipment.
• Data analysis, documentation of results, and presentation of data findings to other members of the company.

We are currently seeking an experienced, highly motivated Molecular Biologist to join our development team. The successful candidate will support the development of an automated DNA extraction and PCR amplification system.  S/he will be involved in the:

• Implementation and optimization of magnetic-bead based nucleic acid preparation, real-time PCR amplification and data analysis.
• Meticulous documentation of experiments and SOPs
• Performance of routine laboratory duties as needed such as maintaining inventory and supplies to ensure uninterrupted research.

Requirements:

We are looking for a highly motivated team player with commitment to quality, attention to detail, strong problem solving skills, and an exemplary work ethic.  Experience working in a cGMP and GLP environment is strongly desirable as well as experience with 510(k) and PMA IVD submissions.

Qualifications:

An MS (with minimum 3 to 5 years industry experience) or PhD (with minimum 1- 3 years industry experience) in Molecular Biology, Biochemistry, or related discipline

• Molecular biology techniques including bacterial culture, DNA isolation and purification, PCR amplification and sequencing.
• Knowledge of DNA and RNA extraction methodologies in a BSL2 environment is highly desirable.
• Excellent experimental planning skills and strong commitment to work in order to meet strict timelines and project goals.
• Ability to work independently as well as in a multi-disciplinary team environment on a variety of different projects simultaneously.
• Strong communication skills.
• Knowledge of protocol writing and documentation of scientific results is critical to the position.
• Experience with working in a clean room environment is desirable.

The Scientist will develop and execute programs in IVD product development and assay validation, molecular diagnostics development, and sample collection/processing approaches.   Experimental strategies include DNA/RNA preparation from tissue, clinical samples, swabs and other bodily fluids, PCR based assay development relating to single base mutation, detection and pathogen detection.  He/she may supervise Research Associates/technicians and coordinate with the external clinical laboratories on technical transfer of developed assays.

Qualifications:

• The ideal candidate has a PhD in a relevant scientific field (Pathology, Molecular Biology, Cancer Biology, Molecular Oncology, infectious disease) and minimum of 3 years industry experience in molecular diagnostics, specifically DNA diagnostic development or a Masters with 7+ years of industry experience in the same arena.
• He/she must have a demonstrated record of scientific accomplishment evidenced by top tier publications and leadership in the field of diagnostics.
• Experience with In vitro diagnostic assay development including 510(k) and PMA submissions to the FDA is preferred.  He/she must be scientifically creative, team-oriented, and passionate.  Excellent written and verbal communication skills are required.

Please Contact us with a word doc or pdf version of your updated CV or resume attached

We do not discriminate in the acceptance or referral of candidates on the basis of race, color, religion, sex, age, national origin, marital status, disability, or other protected characteristic.