Essential Functions
- Develop new analytical methods for its intended use.
- Verify, validate, and transfer analytical methods to the QC as required for business needs.
- Perform testing of raw materials, in-process, intermediates and finished product samples according to compendial, internal or customer‑provided methods and compare results to internal or customer specifications.
- Aid in maintaining efficient turnaround time of analysis to support NPI and business needs in collaboration with cross‑functional departments. Communicate analytical results to the Principal Analytical Chemist and other relevant parties in a timely manner.
- Employ sound and compliant laboratory techniques and logic per industry standards to assist in troubleshooting, investigating and resolving analytical challenges through critical analysis.
- Assist with maintenance and troubleshooting of analytical lab equipment to minimize downtime. This will include but is not limited to maintenance of analytical balances, pH meter, UV‑Vis, FTIR, Karl Fischer, HPLC, GC, GPC, LCMS, GCMS, and NMR.
- Familiar with ISO or GMP documentation (hard copy and electronic) of analytical results and assurance of laboratory.
- Knowledge with ICH Guidelines and USP Guidelines for Analytical Method Validations.
- Support audit readiness with understanding of FDA and ISO regulations and requirements.
- Maintain a safe, clean, and organized environment (5S) for all laboratory areas.
Qualifications
- A Bachelor's Degree in Chemistry, Biochemistry, Biology, or a related field is required, along with 3 years of industry experience, including at least 1 year of experience in troubleshooting analytical methods.
- One plus (1+) years of experience verifying and troubleshooting analytical methods in an ISO 9001/ISO 13485 or FDA GMP regulated environment required.
- Ability to solve problems through chemistry knowledge, literature searching, and discussions with other team members.
- Strong knowledge of analytical equipment, analytical methods, and data analysis required. Must have hands‑on experience working with volumetric glassware and analyzing samples using a variety of computerized analytical equipment, analytical balances, pH meter, UV‑Vis, FTIR, Karl Fischer, HPLC, GC, GPC, LCMS, GCMS, and NMR.
- Good communication skills with the analytical team, and other internal teams required. Must be able to work multiple tasks and projects simultaneously per business needs.
- Knowledge of compendial methods (ie. USP, EP, ISO, ASTM and or ANSI) and ICH guidelines application preferred.
- Certification(s): Specify preferred or required. N/A
- Computer Skills Required: Proficiency with Microsoft Word, Excel, and PowerPoint. Knowledge and experience with ChemStation/ OpenLab, Empower, VNMRJ, MNova, Agilent Microlab, Omnic or LIMS is required.
- Must have legal authorization to work in the U.S. and will not require sponsorship.
What We Offer
Culture, Great people, Peer to Peer Recognition, Broader, hands‑on work experience, Clean and modern equipment & labs, Fun company events, Competitive wages & generous year‑end bonus, Comprehensive benefits, 3 PPO medical plans with telemedicine, Rx, & vision, 2 dental plans, Healthcare, dependent care, & commuter flexible spending accounts, 401(k) with company match, Financial health & wellness w/1:1 coaching & rewards, Basic & supplemental life insurance, Accident, hospital indemnity, & critical illness, Paid Time Off, Paid parental leave, Short & long‑term disability, 9 paid holidays.
Equal Opportunity Employer
Polysciences is an equal opportunity employer. Drug‑free workplace. Tobacco‑free work site.
Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non‑disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.
Equal access to programs, services, and employment is available to all persons. Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.