Mannkind Corporation
Scientist III (Data Reviewer), Quality Control (2nd shift, Tues-Sat, 12:30pm to
Mannkind Corporation, Danbury, Connecticut, us, 06813
Position
Scientist III (Data Reviewer), Quality Control (2nd shift, Tues-Sat, 12:30pm to 9pm) Location
Danbury, CT Job Id
111312 Number of Openings
1 About MannKind
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more. Job Summary
Provides general support to maintain quality control systems within the company. Ensures that performance and products conform to established company and regulatory standards. Analyzes finished formulations, raw materials, in process materials, or stability samples by HPLC/GC, in support of the company's quality program. Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
Working Hours: 12:30pm to 9pm, Tuesday to Saturday. Additional stipend earned for working Evening Shift and Saturdays. Responsibilities
Conduct routine and non-routine HPLC/GC analysis of raw materials, in process, and finished formulations according to standard operating procedures. Perform chemical analyses of product to ensure stability. Compile data for documentation of test procedures that may include microbiological and/or chemical assays, stability program testing and formulation studies. Calibrate and maintain lab equipment. Participate in the preparation of investigations, summaries and reports. May assist in developing testing methods. Review data obtained for compliance to specifications and report abnormalities. Revise and update standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. Applies knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis. Follows written test methods and protocols. Process data, report data and prepare tables and graphs for the completed testing. Identify problems, e.g. out of trend data. Professional interactions are primarily within the QC organization. Responsible for observing all Company, Health, Safety and Environmental guidelines. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player. Minimum qualifications
BS Degree in a scientific discipline with minimum of 4-6 years related experience or Masters with 2-4 years or an equivalent combination of training and experience At least 5+ years' experience in a laboratory setting, preferably in pharma Minimum 5+ years' experience in quality control systems Must have Empower experience Good written communication skills Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred Good interpersonal skills Access, Excel, Word and Power Point skills Pay Range
$80,000 - $120,000 per year
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Scientist III (Data Reviewer), Quality Control (2nd shift, Tues-Sat, 12:30pm to 9pm) Location
Danbury, CT Job Id
111312 Number of Openings
1 About MannKind
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more. Job Summary
Provides general support to maintain quality control systems within the company. Ensures that performance and products conform to established company and regulatory standards. Analyzes finished formulations, raw materials, in process materials, or stability samples by HPLC/GC, in support of the company's quality program. Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
Working Hours: 12:30pm to 9pm, Tuesday to Saturday. Additional stipend earned for working Evening Shift and Saturdays. Responsibilities
Conduct routine and non-routine HPLC/GC analysis of raw materials, in process, and finished formulations according to standard operating procedures. Perform chemical analyses of product to ensure stability. Compile data for documentation of test procedures that may include microbiological and/or chemical assays, stability program testing and formulation studies. Calibrate and maintain lab equipment. Participate in the preparation of investigations, summaries and reports. May assist in developing testing methods. Review data obtained for compliance to specifications and report abnormalities. Revise and update standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. Applies knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis. Follows written test methods and protocols. Process data, report data and prepare tables and graphs for the completed testing. Identify problems, e.g. out of trend data. Professional interactions are primarily within the QC organization. Responsible for observing all Company, Health, Safety and Environmental guidelines. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player. Minimum qualifications
BS Degree in a scientific discipline with minimum of 4-6 years related experience or Masters with 2-4 years or an equivalent combination of training and experience At least 5+ years' experience in a laboratory setting, preferably in pharma Minimum 5+ years' experience in quality control systems Must have Empower experience Good written communication skills Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred Good interpersonal skills Access, Excel, Word and Power Point skills Pay Range
$80,000 - $120,000 per year
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