Senior Oligonucleotide Chemist - Design Transfer

Organization
Luminex Corporation
Job Location
Madison, WI
Job Description

The Sr. Oligonucleotide Chemist-Design Transfer is the process technical expert in all elements of manufacturing Oligonucleotides. This position is responsible for establishing method validation protocols and executing validation studies for oligonucleotide synthesis, purification and purity analysis. It is expected that the person in this position will work closely with the Chemistry research and development group to facilitate the transfer of test methods and processes developed in research to the Manufacturing operation. Responsibilities include drafting and execution of validation protocols, evaluate and improve processes, and management of timelines

Key Responsibilities of the Job:

  • Review nucleotide product manufacturing documents to ensure quality procedures are met and plan/prioritize to address potential production issues.
  • Work with Chemistry research and development group to lead/participate in troubleshooting activities related to oligonucleotide, phosphoramidite and triphosphate synthesis (CAPA and otherwise) and lead documentation changes and procedures.
  • Lead continuous improvement activities for: 
  • --     oligo synthesis - adjust process to meet production capacity needs and ensure any appropriate documentation changes are established through the change control process. 
  • --     oligo analysis – In conjunction with Chemistry research and development, regularly evaluate and advise on the process to ensure effectiveness according to industry standard practice and confirm performance (chemically reasonable impurities)
  • --     triphosphate synthesis - In conjunction with Chemistry research and development incorporate synthetic method improvements into the manufacturing processes and be responsible for ensuring that appropriate documentation changes are established through the change control process.
  • Performs change control as required to support change requirements including engineering change orders, document change orders and deviations.
  • Participates in the evaluation and approval of manufacturing processes and resources to successfully introduce new products and/or apply major changes to existing products. Provides input to new product and project schedules for new process and/or test method deliverables.
  • Facilitates/participates in cross functional teams to establish new outsource providers as necessary. Coordinate outsource testing and interface with outsource providers as the technical representative as needed.
  • Guide and advise on the proper purchase, installation, use, and maintenance of laboratory equipment for manufacturing use. Work in collaboration with Chemistry research and development to define any new product/process requirements and propose for capitol budgets.
  • Work with Chemistry research and development group on new product development to ensure knowledge transfer into manufacturing.
  • Participate on manufacturing and project teams as required.
  • Ensures that nucleotide synthesis team is properly trained on systems, processes & equipment.
  • Assure that quality procedures and instructions are being followed and results are meeting objectives.
  • Participate in meeting site safety and chemical hygiene requirements; may provide leadership as Chemical Hygiene Officer as required and if appropriate.
  • Investigate complaints and non-conformances. Develop and implement corrective and preventive actions.
  • Perform additional tasks as assigned.

 

 

Requirements

Education/Work Experience:

  • Ph.D.(Preferred) in organic chemistry with at least 5 years experience in chemistry related GMP process manufacturing, preferably in a diagnostic or medical device environment  OR
  • Master’s degree in in organic chemistry with at least 8 years experience in chemistry related GMP process manufacturing, preferably in a diagnostic or medical device environment OR
  • Bachelor's degree in organic chemistry with at least 10 years of experience in chemistry related GMP process manufacturing, preferably in a diagnostic or medical device environment 

Required Certifications/License/Special Skills:

  • Knowledge of FDA quality systems requirements, ISO 13485 and cGMP requirements.
  • Experience writing and executing validation protocols and methods as well as drafting of manufacturing methods and documentation.
  • Excellent skills using software tools such as MSProject, MSAccess, MSWord, MSExcel, PowerPoint, Outlook,
  • Excellent organizational, written and verbal communication skills required.
  • Ability to work independently and with minimal supervision
  • Ability to handle the pressure of meeting tight deadlines
  • Knowledge of chemical hygiene requirements and lab safety as gained by working in a chemical laboratory; experience as chemical hygiene officer or member of safety team or formal training in chemical safety leadership highly desired.

Competencies:

  • Customer Focus— dedication to the customer and earns their trust and respect
  • Organizational Agility—knows how to go through the proper channels to get things done
  • Peer Relationship—cooperative, team player, trusted and supported by peers
  • Planning—sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps
  • Presentation Skills—effective in all settings such as one-on-ones, with small or large groups, with peers or bosses, etc.
  • Problem Solving— identifies complex problems and reviews related information to develop and evaluate options and implement solutions
  • Process Management—ability to simplify complex processes and to organize people and activities
  • Written Communications—effectively communicates in writing

 

About Our Organization

Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP® open-architecture multi-analyte platform, MultiCode® real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex's technology is commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology, and life science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research, and food safety. 

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