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Analytical Chemist II

Analytical scientist II in R&D is responsible for the development and validation of analytical methods for new drug products and new drug substances. These methods include assa...

Posted 1 week ago

Analytical scientist II in R&D is responsible for the development and validation of analytical methods for new drug products and new drug substances. These methods include assay, impurities/degradants, preservatives, alcohol and any other analytes to be monitored in the finished product. The analytical scientist will be using UPLC, HPLC, GC, FTIR, UV and other analytical instruments as needed. Write protocols and final reports in accordance with current FDA regulations, ICH guidelines, USP monographs, and Novocol Healthcare SOPs. Responsibilities included but not limited to: <ol> <li>Develop and validate HPLC and GC analytical methods for drug substances, drug product, preservatives and degradation/impurities.</li> <li>Perform validation experiments as per approved method validation protocols, Novocol Healthcare SOP and ICH guidelines.</li> <li>Perform in-process, finished product/release and stability testing of dosage forms as per the approved methods.</li> <li>Perform OOS and OOT investigation of drug substance and drug product as necessary.</li> <li>Perform analytical method transfer from R&D to QC laboratory for newly validated methods</li> <li>Write/revise analytical methods, method validation protocols, method validation reports, method transfer protocols/reports</li> <li>Perform calibration of analytical equipment as per approved procedures</li> <li>Document all activities in the appropriate laboratory notebook as per Novocol Healthcare procedures and cGMPs.</li> </ol> WORK PERFORMED: (approximate breakdown by percentage) <ul> <li>Method Development: 20%</li> <li>Method Validation: 40%</li> <li>Stability testing of drug product: 10%</li> <li>Writing Technical Documents: 10%</li> <li>Testing new raw materials: 10%</li> <li>Method transfer activities: 10%</li> </ul> Required Skills <ul> <li>Hands-on instrumentation experience using analytical techniques such as HPLC, GC, UV, FTIR etc.</li> <li>In depth Knowledge of separation and spectroscopic sciences.</li> <li>Ability to adopt fast pace working environment.</li> <li>Good verbal and written communication skills.</li> <li>Good documentation skills are preferred.</li> <li>Good analytical skills in developing and validating analytical methods for semi-solid generic products.</li> <li>Knowledge of the USP, FDA requirement is a must.</li> </ul> Required Experience <ul> <li>S/M.S in Analytical Chemistry or related discipline with 2-6 years of experience in pharmaceutical generic environment</li> </ul>

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Process Technology Engineer

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Ascend Performance Materials Decatur AL, 35602

As a member of the Ascend Performance Materials Technology Organization in Decatur, the Process Technology Engineer will both lead the execution of key Technology programs through ...

Posted Today

As a member of the Ascend Performance Materials Technology Organization in Decatur, the Process Technology Engineer will both lead the execution of key Technology programs through the Stage Gate process and will provide key engineering support. The Process Technology Engineer will also drive improvements in the bench scale pilot facilities. These improvements will be aimed at improving experimental throughput as well as improving the ability to scale up results to full commercial production. Programs within the Decatur Technology organization are in support of the adiponitrile process. The adiponitrile facility at Decatur is the world's largest production facility utilizing organic electrochemistry for the synthesis of organic products. TARGETED OUTCOMES * Efficient execution of Stage Gate Programs: Successfully lead cross functional project teams to implement "game changing" improvements in the plant. These improvements are typically process chemistry related improvements tested at bench scale. * Step change improvement in effectiveness of lab tools: Lead improvements to bench scale piloting facilities to improve the ability to predict plant scale performance and improve the throughput capabilities of those tools. KEY RESPONSIBILITIES Safety * Serve as an influential leader in safety, setting the right example and influencing others to close safety behavior gaps. * Insure that all safety issues/ concerns associated with programs are identified and properly managed. Leadership * Lead the activities of cross functional teams of PhD chemists and engineers to insure proper execution of stage gate ideas. * Be accountable for the execution of team actions to reach program goals. Communication * Be able to translate needs and objectives into actionable goals. * Escalate any issues and/or barriers to success so that they can be properly managed. * Must be able to communicate effectively with a wide range of people, from PhD chemists to operations personnel. REPORTS TO Site Process Technology Leader TEAM * The Decatur Technology Team is comprised of B.S. and PhD. Chemists and Lab Technicians. Stage Gate teams include Production Engineers, Manufacturing Engineers, and Process Engineers. REQUIRED EXPERIENCE * Minimum B.S. in Chemical Engineering. * Minimum 10 years of experience in chemical industry. * Experience in scaling up from lab scale to industrial chemical processes. * Experience with a wide variety of unit operations (liquid extractors, distillation, liquid-liquid separation devices, reactors, etc.). DESIRED CERTIFICATION * Six Sigma Certification is a plus. REQUIRED SKILLS * Organized and well-structured leader. * Capable leader effective at driving for results and holding others accountable. * Capable of distilling complex interactions into simple, understandable, and useful models. * Skilled at interpreting data and input from others. Capable of questioning and objectively separating fact from fiction. * Capable of anticipating risks and developing plans to mitigate and/or retire those risks. * Skilled in using sound statistics to draw conclusions and design experiments (DOE). * Knowledge of basic plant instrumentation and analytical techniques. * Good understanding of "plant finance" as it pertains to understanding program costs and benefits. Why work at Ascend? If you are looking for a career with one of the plastics industry's most enlightened employers, Ascend Performance Materials offers an opportunity to develop a true sense of fulfillment and pride in your achievements. Ascend provides an exciting platform from which you, your family and your community will benefit. You'll become a trusted member of an interdependent and safe working environment where your opinions and ideas will be encouraged and respected, regardless of your position. Working alongside a diverse range of renowned technical experts on a continuous stream of industry-leading products and technologies, you'll find a wide variety of opportunities within our growing business for both learning and career development. Our culture is built on a strong set of core values that foster innovation and collaboration across every level of the organization. It is a culture grounded in open relationships between every member of the Ascend team. All of this is driven by an inspirational leadership team, intently focused on maximizing the new investment in the business. The essence of our organization is embodied in the words "inspiring everyday," and we have built a strong and confident business with performance at its core. It will be challenging but holistically rewarding and will enable you to achieve your personal and professional aspirations. Ascend is an organization that genuinely seeks to inspire our people to inspire others. We believe this gives Ascend a higher purpose, making it a unique work environment for you to consider when choosing career options.

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Operator (Night Shift)

Basf Huntsville AL

At BASF, we create chemistry through the power of connected minds. By balancing economic success with environmental protection and social responsibility, we are building a m...

Posted 3 weeks ago

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Agency Owner

Farmers Insurance Decatur AL

You know how to manage a team, achieve great chemistry and instill a standard of excellence. PERFORMANCE * You recognize the irreplaceable value of hard work and what it tak...

Posted 2 weeks ago

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Warehouse Technician

OCI Alabama LLC Decatur AL

After all, great people and great products equal perfect chemistry

Posted 6 days ago

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Agency Owner

Farmers Insurance Huntsville AL

You know how to manage a team, achieve great chemistry and instill a standard of excellence. PERFORMANCE * You recognize the irreplaceable value of hard work and what it tak...

Posted 2 weeks ago

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Maintenance Technician

OCI Alabama LLC Decatur AL

After all, great people and great products equal perfect chemistry

Posted 3 weeks ago

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Aerospace System Safety Engineer (Clearance Required) With Security Clearance

Geocent Huntsville AL

Bachelor, Master or Doctorate of Science degree from an accredited course of study, in engineering, computer science, mathematics, physics or chemistry . ABET is the preferre...

Posted 3 weeks ago

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Aerospace System Safety Engineer With Security Clearance

Moseley Technical Services, Inc Huntsville AL

Degree from an accredited course of study, in engineering, computer science, mathematics, physics or chemistry . ABET is the preferred, although not required, accreditation s...

Posted 3 weeks ago

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Aerospace Electrical Engineer With Security Clearance

Moseley Technical Services, Inc Huntsville AL

Degree from an accredited course of study, in engineering, computer science, mathematics, physics or chemistry . ABET is the preferred, although not required, accreditation s...

Posted 3 weeks ago

Analytical Chemist II

Process Technology Engineer

Operator (Night Shift)

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Agency Owner

Warehouse Technician

Agency Owner

Maintenance Technician

Aerospace System Safety Engineer (Clearance Required) With Security Clearance

Aerospace System Safety Engineer With Security Clearance

Aerospace Electrical Engineer With Security Clearance

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Analytical Chemist II

Process Technology Engineer

Operator (Night Shift)

Boost your job search productivity with our free Chrome Extension!

Agency Owner

Warehouse Technician

Agency Owner

Maintenance Technician

Aerospace System Safety Engineer (Clearance Required) With Security Clearance

Aerospace System Safety Engineer With Security Clearance

Aerospace Electrical Engineer With Security Clearance

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See jobs right for you!

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Chemist at Decatur, Alabama.

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