Google-analytics Remote- und Homeoffice Jobs ∙ Seite 3

JOB SUMMARY

Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench. This individual will be accountable for the establishment, development, and qualification of analytical methods and method transfer to QC. The individual will also support training of QC team on methods and validation activities as appropriate. The person is expected to work collaboratively with the team to establish and implement best regulatory, laboratory practices and to lead the execution of complex experiments. The position requires expertise in method development in the biophysical characterization of AAV particles with an emphasis on HPLC based methodology using various detectors including UV-Vis, CAD, and MALS detectors. Prior expertise in use of MALS and CAD detectors is a strict requirement for this position.

This position will be filled at the Scientist I, II, or III level, dependent upon the qualifications and experience of the successful candidate.

JOB RESPONSIBILITIES

• Expert in HPLC based methodology development and establishment using MALS and CAD detectors for use in the characterization of AAV vectors.
• Must be able operate HPLC associated equipment including equipment troubleshooting as required without support.
• Familiarity with OpenLab and Empower software packages for the analysis of HPLC based readouts.
• Maintain familiarity with current equipment used in Analytics lab
• Help management evaluate new technology and bring new platforms in-house
• Qualify analytical methods to support cGMP testing
• Help facilitate tech transfer of analytical and bioassays from clients to AD lab and from AD lab to QC lab
• Supervise and train AD Associates and AD Technicians and work closely with other departments, assisting in project planning
• Support the establishment of electronic record keeping systems for site; e.g. LIMS or ELN
• Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of biological products
• Work as a team with process development, manufacturing, quality assurance and quality control departments as needed
• Advise site and quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued
• Execute research timelines to meet program and corporate objectives
• Deal with abstract and concrete variables in situations where only limited standardization exists
• Maintain high quality deliverables and open communication, creating a collaborative working environment
• Contribute to collaborative, creative and rigorous culture of scientific discovery
• Provide weekly reports to department head in 1:1 environment

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

Pay Range:
This position will be filled at the Scientist I, II, or III level, dependent upon the qualifications and experience of the successful candidate. The annual salary range for the Scientist I-III is $85,000-$130,000.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in BSL2 environment with personal protective equipment/aseptic gowning
• Occasionally exposed to moving mechanical parts, toxic or caustic chemicals, hazardous waste, and similar hazards associated with pharmaceutical lab facilities

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail