Job Title:

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FLSA Status:

DNA Synthesis Lab Supervisor

R&D

Chemistry Manager

Pasadena

March/April 2009

Exempt

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Purpose of the Position: Handle the day-to-day operations of the oligonucleotide production staff which includes, but is not limited to, designing and directing implementation plans, planning and re-prioritizing of assignments, and deploying resources.  Timely delivery of high quality oligonucleotides for internal product development and IVD production.  Nucleic acid synthesis, purification, and analytical characterization.  Carry out experimentation consistent with company practices, procedures and Quality Assurance policies.  Document experimental procedures including when applicable executing controlled batch records for oligonucleotide manufacture.  Ensure technology transfer of oligonucleotide synthesis into Manufacturing occurs with appropriate analytical quality specifications.

 

Essential Duties and Responsibilities (other duties may be assigned):

  • Work under general direction of manager to carry out day-to-day operational objectives, documenting laboratory experiments, interpreting and analyzing experimental results. Provide periodic updates and summarize work for review as needed
  • Oversee the operation of laboratory and equipment as needed for oligonucleotide synthesis (typically 1 µmole to <10 µmole), purification and characterization.
  • Apply knowledge of nucleic acid chemistry conduct experiments to investigate new- or improved-oligonucleotide production processes that will meet diagnostic product objectives.
  • Carry out analytical procedures development and analytical method validations consistent with corporate goals and timelines
  • Implement analytical chemistry as needed using methods that may include HPLC, gel analysis, spectrophotometry, fluorescence spectrophotometry, ion analysis, Mass Spectrometry, moisture analysis (eg. Karl Fisher)
  • Develop, implement and maintain procedures performed to the appropriate quality standards for R&D product development, technology transfer, and production
  • Summarize work as appropriate for internal or external reporting purposes, represent work at internal and external meetings as required, and propose new strategies to address immediate and upcoming technical issues.
  • Implement staff goal setting, personnel growth plans and performance management

 

Supervisory Responsibilities: Directly supervise and coordinate the work of staff including lower level chemists and/or research associates.  Will train and assist others in DNA synthesis, purification and analytical methodology.

 

Qualifications:  To perform this job successfully, the individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Demonstrated leadership, interpersonal, communication and problem-solving skills
  • B.S./M.S. in biochemistry, organic chemistry, chemical engineering or equivalent work experience
  • Minimum of 2 years oligonucleotide production supervisory experience
  • Solid fundamental understanding of oligonucleotide synthesis, purification and analysis
  • Maintenance and minor repair of DNA synthesis-, HPLC- and standard-laboratory equipment
  • Strong familiarity with manufacturing process control, ISO and QSR requirements
  • Collaboration with external scientists on projects, including data presentation, data summary and experimental planning
  • Advanced chemistry knowledge of laboratory safety, hazardous waste handling and waste management

 

Education and Experience:  Chemistry, B.S. >8 years, M.S. with >5 years or Ph.D. with 0-2 years relevant nucleic acids synthesis / industrial experience.  In vitro diagnostic experience preferred.

 

Language Skills:  Must be proficient in writing and communicating in the English language.

 

Mathematical Skills:  Must be consistent with M.S. level education

 

Reasoning Ability:  Good problem solving, judgement and decision making skill are required

 

Certifications, Licenses, Registrations:  None required

 

Physical Demands:  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance.  Work entails occasional lifting and/or moving up to 25 pounds.  Work occasionally requires travel between buildings.  This is typically completed by foot or by car.


The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.

 

Work Environment:  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration.  The noise level in the work environment is usually moderate.