Sr. Analytical Chemist IVD Reagents and Small Molecules
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Job Location:
Des Plaines, IL - USA
Monthly Salary:
$ 78000 - 156000
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Sr. Analytical Chemist IVD Reagents and Small Molecules
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.
The Opportunity
At Molecular Diagnostics we realize the potential of personalized care as the laboratorys most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories a global diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.
Position: Sr. Analytical Chemist IVD Reagents and Small Molecules
Location: Molecular Diagnostics Business Unit Des Plaines Illinois
AMD Molecular is recruiting for an Sr. Analytical Chemist IVD Reagents and Small Molecules with deep expertise in ion chromatography (IC) highperformance liquid chromatography (HPLC) and atomic absorption (AA) spectroscopy to support the development and validation of reagents raw materials and small moleculesincluding oligonucleotides and nucleicacid probesused in in vitro diagnostic (IVD) assays. Proficiency in LCMS for detailed oligonucleotide and smallmolecule characterization is also preferred.
What Youll Work On
1. Analytical Method Development & Testing
- Develop optimize and validate analytical methods using IC HPLC AA and LCMS to support characterization of raw materials reagents oligonucleotides nucleicacid probes and other small molecules.
- Perform routine and nonroutine testing to ensure compliance with specifications for raw materials intermediates and finished reagents.
- Design and execute analytical experiments supporting IVD assay development smallmolecule characterization formulation optimization and stability studies.
2. Instrument Ownership & Troubleshooting
- Operate maintain and troubleshoot analytical instrumentation including IC and HPLC systems equipped with UV conductivity and massspectrometry detection.
- Maintain instrument readiness calibration and associated documentation in accordance with GMP/GLP requirements.
3. Documentation Quality & Regulatory Compliance
- Prepare and review validation protocols test methods technical reports SOPs and analytical sections of regulatory submissions.
- Ensure data integrity and compliance with 21 CFR 820 ISO 13485 and applicable FDA/ICH/USP guidelines.
- Generate analyze and interpret complex analytical data sets to support product development investigations and quality decisionmaking
4. CrossFunctional Support & Investigation Leadership
- Lead analytical investigations including rootcause analysis and provide technical recommendations for corrective and preventive actions (CAPA).
- Collaborate with R&D Quality Manufacturing and other stakeholders to support product development process validation and material assessments.
- Serve as a subjectmatter expert in analytical methodologies providing technical guidance to crossfunctional teams.
5. Training & Mentorship
- Train and mentor junior staff in analytical techniques instrument best practices and dataintegrity requirements.
Required Qualifications
- Masters or Ph.D. in Analytical Chemistry Chemistry Biochemistry or related field; Bachelors with significant experience considered.
- 5 years of analytical method development and validation experience in a regulated environment.
- Demonstrated expertise in IC HPLC AA and LCMS for characterization of oligonucleotides nucleicacid probes and other small molecules.
- Familiarity with complementary material characterization techniques (e.g. UVVis Karl Fischer TOC).
- Experience with GMP/GLP method lifecycle and regulatory documentation.
- Strong statistical foundation for method validation.
Preferred
- Proficiency in LCMS for detailed oligonucleotide and smallmolecule characterization is also preferred.
- Experience with biologics enzymes or complex matrices.
- Knowledge of data integrity principles and electronic laboratory systems (e.g. LIMS ELN).
- Knowledge of design control and risk management in the context of IVD product development.
- Prior experience supporting 510(k) or PMA submissions is a plus.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.
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The base pay for this position is
$78000.00 $156000.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Manufacturing
DIVISION:
AMD Molecular
LOCATION:
United States > Des Plaines : DP01
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday) Routine work with chemicals Work in a clean room environmentAbbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Senior IC
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