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Scientist II
Ref No.: 17-14572
Location: Frederick, Maryland
Key Objectives of the role:

Support continuous improvement, new product development and method transfers.
Provide technical support for the manufacture and analytical testing of products.
Plans, schedules and performs testing of processes and reagents utilizing techniques such as OD, pH and conductivity measurements; PCR; qPCR; RT-qPCR
Collects and analyzes data, and creates reports
Participates in drafting manufacturing documentation such as production SOPs

Participates in the design and execution of method and process validations.
Troubleshoot issues/conduct root cause analysis and to recommend and implement corrective actions for processes
Develop and maintain detailed plans and schedules for all tasks
Maintains accurate records and documentation; responsible for the quality of project deliverables and documentation
Serve as technical liaison between R&D and Operations



Experience with RNA/DNA isolation, qPCR and method/process validation.
Proficiency in Excel.
Excellent time management skills and ability to perform independently and as part of a team.
Ability to work in dynamic, fast paced team environment.
Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle projects and priorities
Experienced with EHS guidelines in a laboratory environment, maintain well documented. laboratory protocols and notebooks.
Strong verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner.
Prepare and summarize scientific results in a clear, concise, accurate manner.
Demonstrated ability to formulate and solve problems.
Knowledge of established Quality Systems, ISO regulations and/or cGMP.

Experience with RNA/DNA isolation, qPCR and method/process validation.
Proficiency in Excel.
Excellent time management skills and ability to perform independently and as part of a team.
Ability to work in dynamic, fast paced team environment.
Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle projects and priorities
Experienced with EHS guidelines in a laboratory environment, maintain well documented. laboratory protocols and notebooks.
Strong verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner.
Prepare and summarize scientific results in a clear, concise, accurate manner.
Demonstrated ability to formulate and solve problems.
Knowledge of established Quality Systems, ISO regulations and/or cGMP.

Preferred Qualifications (nice to have):

Experience with Mass Spec, HPLC, and HPIC analytical methods
Continuous improvement Experience (PPI, Six Sigma, 5S).
Familiarity with statistical analysis; experience with tools such as JMP and/or Minitab a plus.
Strong systems/process orientation with demonstrated analytical thinking, organizational skills and problem solving skills.
Understanding of ISO9001 and ISO13485 requirements. Familiarity with 21CFR Part820 requirements.
Experience in Pharma, Medical Device, or clinical lab QC environment.
Experience with ISO 13485 and cGMP.