Pharmaceutical Analytical Chemist II

1 week ago

Huntsville, United States TriRx Huntsville LLC Full time
Job DescriptionJob Description

Job Summary

An Analytical Chemist II will be part of a team responsible for ensuring the analytical readiness for incoming projects in a CDMO environment by performing method transfer, validation, or verification as appropriate. The position will define and execute analytical requirements in an accurate and timely manner to meet current regulatory requirements and expectations of the customer. Strong leadership, scientific writing, and laboratory skills are required.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

The Analytical Chemist II operates within the Analytical Technical Services and Quality Control Laboratories, under the directions of the Technical Services and Quality Organization.

The Analytical Chemist II has no budget/spend authority, but may act as SME in the selection of materials and equipment.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Floor

Operations

  • Maintain a clean, organized, and safe work area.
  • Perform daily calibrations and maintenance on analytical equipment, such as analytical balances, pH meters, density meters, etc.
  • Prepare test solutions, compounds, or reagents for analysis of raw materials and finished products.
  • Accurately and precisely perform analytical testing using a variety of wet chemistry techniques, such as weighing and measuring, density, specific gravity, pH, viscosity, titration, and conductivity.
  • Perform assay, impurity/degradant, and solvent determinations by chromatographic analysis via thin-layer, gas (GC), high performance (HPLC), Mass Spectroscopy, and ultra performance chromatography (UPLC).
  • Perform minor maintenance and troubleshooting on chromatographic equipment.
  • Multitask projects while maintaining high levels of accuracy
  • § Other duties as assigned

75%

Non-Conforming Events

  • Complete basic laboratory investigations with a thorough understanding of root cause analysis and required CAPAs

15%

Process Improvement

  • Work in cross functional teams as necessary to complete projects, method transfers, verifications, validations, and investigations

10%

Compliance

  • § Maintain current training compliance on assigned SOPs and company policies
  • § Accurately and legibly document and record all work completed so that analyses may be fully traceable and reproducible
  • § Identify as an expert on at least one type of laboratory equipment, and acts as a SME for that instrument

continuous

Safety

  • Operate under all corporate safety requirements at all times, including use of PPEs and adherence to company policies in handling of hazardous substances

continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

  • Bachelor’s degree in Chemistry or Related Field with 3-5 years experience in Analytical Development

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Knowledge of FDA regulations
  • HPLC & GC (Required)
  • Familiarity with Current Good Manufacturing Practices (cGMPs)
  • Familiarity with analytical laboratory operations and associated safety requirements
  • Possesses an expanded understanding of chromatography with ability to troubleshoot most problems without support
  • Conduct method validation activities in support of API, excipient, finished drug product, and stability testing
  • Coordinate Technical Services, Operations, QA, QC, and other relevant departments within TriRx
  • Author and execute protocols for analytical method validation, verification, and transfer.
  • Work as part of a team in conducting method validation/verification/transfer activities
  • Write thorough and accurate method validation reports and final test methods in a timely manner
  • Reports to the Analytical Technical Services Manager
  • Perform other related functions as needed to complete overall company and department objectives.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

  • Experience with chromatographic equipment and integration software
  • Experience with Microsoft Office Suite of Products, including Word, Excel, and Teams
  • Analytical laboratory experience
  • Skilled in analytical method development, validation, verification, and transfer
  • Expertise in chromatography to include HPLC, UPLC, GC, IC, and LCMS as well as spectral (FTIR, UV/VIS, etc) and wet chemistry techniques on API, excipient, in-process, and liquid pharmaceutical formulations
  • Commitment to safety, cGMP compliance, and DEA regulations
  • Must be able to work in a team environment, communicate, organize, plan, and execute projects
  • Strong scientific writing skills required

  • Scientist, Biologics Analytical Development

    Found in: Appcast US C2 - 1 week ago

    Huntsville, United States TalentBurst, an Inc 5000 company Full time

    Participates and occasionally leads in analytical method development and product characterization of recombinant proteins and conjugated proteins derived from microbial and/or mammalian expression systems.Performs day-to-dayhands on operation for development and optimization of analytical methods. Characterizes protein molecule and complex protein conjugates...

  • Scientist, Biologics Analytical Development

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Huntsville, United States TalentBurst, an Inc 5000 company Full time

    Participates and occasionally leads in analytical method development and product characterization of recombinant proteins and conjugated proteins derived from microbial and/or mammalian expression systems.Performs day-to-dayhands on operation for development and optimization of analytical methods. Characterizes protein molecule and complex protein conjugates...

  • Process Technician II

    Found in: beBee S US - 1 week ago

    Huntsville, United States Nektar Therapeutics Full time

    The Process Technician II is responsible for manufacturing clinical and commercial products in compliance with regulatory requirements, current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDP), and Standard Operating Procedures (SOPs). Duties / Responsibilities may include: Reading, understanding, and strictly following all written...

  • Process Technician II

    Found in: beBee jobs US - 1 week ago

    Huntsville, Alabama, United States Nektar Therapeutics Full time

    The Process Technician II is responsible for manufacturing clinical and commercial products in compliance with regulatory requirements, current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDP), and Standard Operating Procedures (SOPs).Duties / Responsibilities may include:Reading, understanding, and strictly following all written...

  • Research Associate II, Quality Control

    Found in: beBee S US - 1 week ago

    Huntsville, United States Nektar Therapeutics Full time

    Responsible for conducting routine and non-routine analysis of raw materials, in-process and finished formulations according to standard operating procedures. Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab equipment. Reviews data obtained for compliance to specifications and reports...

  • Research Associate II, Quality Control

    Found in: beBee jobs US - 7 days ago

    Huntsville, Alabama, United States Nektar Therapeutics Full time

    Responsible for conducting routine and non-routine analysis of raw materials, in-process and finished formulations according to standard operating procedures.Compiles data for documentation of test procedures and prepares reports.Calibrates and maintains lab equipment.Reviews data obtained for compliance to specifications and reports abnormalities.Revises...

  • Sr. Systems Administrator

    1 week ago

    Huntsville, United States Latitude, Inc. Full time

    Job DescriptionJob DescriptionResponsibilities include:Direct System Administration activities at APC/LPC/Data Center locations.Responsible for all duties performed by Mid-Level SA in addition to oversite of activities.Directs and monitors installation, configuration, and consolidation of servers and services.Monitors hardware performance and disk storage...

  • Sr. Research Associate

    Found in: beBee S US - 2 weeks ago

    Huntsville, United States Nektar Therapeutics Full time

    The Sr. Research Associate - Quality Control (Raw Material Supervisor) is responsible for conducting routine and non-routine analysis of raw materials (sampling if required), in progress and finished formulations according to standard operating procedures. Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab...

  • Test Engineer II- Secret with Security Clearance

    Found in: Dice One Red US C2 - 1 week ago

    Huntsville, United States Jacobs Technology, Inc. Full time

    Your Impact: Jacobs is hiring for a Test Engineer to support our team in Huntsville, AL. You will be working in Department of Justice organization that's mission is to accelerate operations through data and new analytical insights. The entire section works to provide the entire enterprise with tools and applications to assist with operational data discovery,...

  • Software Systems Engineer with Security Clearance

    Found in: Dice One Red US C2 - 1 week ago

    Huntsville, United States Onyx Government Services, LLC Full time

    Essential Functions: - Collaborate with cross-functional teams to understand project requirements and deliver high-quality software solutions.- Implement and test software components, ensuring they meet project specifications and adhere to best practices.- Designs systems software to meet project requirements, collaborating with systems analysts, engineers,...

  • Senior Computer Hardware Engineer with Security Clearance

    Found in: Dice One Red US C2 - 1 week ago

    Huntsville, United States Onyx Government Services, LLC Full time

    Essential Functions: - Designing and developing hardware components.- Testing hardware components individually and in tandem with external computer systems.- Analyzing systems data in order to make changes to the hardware configuration.- Completing functionality and performance tests on the final product.- Designing hardware for computer-related products...

  • Sr. Research Associate

    Found in: beBee jobs US - 2 weeks ago

    Huntsville, Alabama, United States Nektar Therapeutics Full time

    The Sr. Research Associate - Quality Control (Raw Material Supervisor) is responsible for conducting routine and non-routine analysis of raw materials (sampling if required), in progress and finished formulations according to standard operating procedures. Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab...

  • Test Engineer II- Secret

    Found in: Talent US A C2 - 1 week ago

    Huntsville, United States Jacobs Full time

    Your Impact:Jacobs is hiring for a Test Engineer to support our team in Huntsville, AL. You will be working in Department of Justice organization that’s mission is to accelerate operations through data and new analytical insights.  The entire section works to provide the entire enterprise with tools and applications to assist with operational data...

  • ETL Engineer II with Security Clearance

    Found in: Dice One Red US C2 - 1 week ago

    Huntsville, United States Advantex Consulting Full time

    ETL Engineer IIILocation: Huntsville, AlabamaClearance Requirement: Top Secret (SCI Eligibility) Role and Responsibilities We are seeking a Data Engineer who can leverage experience and expertise in data exploration, engineering, and ETL to explore, architect, develop, and deploy scripts for processing structured and unstructured data into usable data...

  • Windows Server Administrator

    1 week ago

    Huntsville, United States Sanmina-SCI Full time

    Position Title: Windows Server Administrator Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior...

  • Systems Administrator

    1 week ago

    Huntsville, United States ISSAC Corp Full time

    Job DescriptionJob DescriptionISSAC offers competitive salaries, Medical, Dental, Vision and Life Insurance. We also have generous PTO, federal holidays off, education assistance, 401K program and profit sharing.  JOB REQUIREMENTS:· Maintain operation of Red Hat Enterprise Linux (RHEL) computer systems· Ability to coordinate with other system and network...

  • Systems Administrator

    2 days ago

    Huntsville, United States ISSAC Corp Full time

    Job DescriptionJob DescriptionISSAC offers competitive salaries, Medical, Dental, Vision and Life Insurance. We also have generous PTO, federal holidays off, education assistance, 401K program and profit sharing.  JOB REQUIREMENTS:· Maintain operation of Red Hat Enterprise Linux (RHEL) computer systems· Ability to coordinate with other system and network...

  • Data Management Specialist/Data Analyst

    2 weeks ago

    Huntsville, United States Qualis Corporation Full time

    Job DescriptionJob DescriptionQualis is seeking a Data Management Specialist and a Data Analyst level I-III. The Data Management Specialist will advise and assist in developing and implementing a data management plan that focuses on the collection, structure/format, entry, validation, editing, and reporting of data; collaborates with pertinent stakeholders...

  • Cloud Developer II

    Found in: Dice One Red US C2 - 1 week ago

    Huntsville, United States Advantex Consulting Full time

    Cloud DeveloperLocation: Huntsville, Alabama (50% Remote)Clearance Requirements: Active Top-Secret Clearance (SCI Eligible) Role & Responsibilities • Build a framework using AWS cloud technologies to collect, transfer, and archive data files of varying formats into a data lake and content warehouse in a consistent way. • Take advantage of new cloud...

  • Network Engineer:

    4 days ago

    Huntsville, United States CareerBuilder Full time

    deciBel Research has an immediate opening for a Senior Network Engineer in Huntsville, AL. Position Description: deciBel Research, Inc. is seeking a Senior Network Engineer to play a pivotal role in a significant project supporting the design, buildout, and management of a DoD facility on RSA. Responsibilities Include: Providing engineering and technical...