Analytical Chemist (Manufacturing)
Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA's ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.
The Analytical Chemist responsibilities include developing, documenting, and validating reproducible analytical methods for the intended purposes. The position also includes working closely with the R&D Synthetic Chemists to improve the understanding of chemical reactions and solve problems encountered during synthesis route selection, process development and scale-up to improve products and processes for New Product Introduction (NPI) and process improvement projects.
Essential Functions:
- Develop new analytical methods for its intended use.
- Verify, validate, and transfer analytical methods to 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 Supervisor of Analytical R&D 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 limit to, maintenance of analytical balances, pH meter, KF coulometer, UV-Vis, FTIR, HPLC, GC, GPC, LCMS, GCMS, ICP-MS 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 and Verifications.
- 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
Education Required: Bachelor's Degree
A Bachelor's Degree in Chemistry, Biochemistry, Biology, or related field is required, along with 3 years of industry experience, including at least 1 year of experience in developing or troubleshooting analytical methods.
- Master's Degree in Analytical Chemistry or related field is preferred along 1 year of industry experience.
- Ph.D degree in Analytical Chemistry, plus 0 year of industrial experience.
Computer Skills Required:
Proficiency with Microsoft Word, Excel, and PowerPoint. Knowledge and experience with OpenLab, Empower, VNMRJ, MNova, OMNISEC or LIMS is required.
Other qualifications:
- 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, KF coulometer, HPLC, GC, GPC, LCMS, GCMS, ICP-MS, and NMR.
- Knowledge of compendial methods (ie. USP, EP, ISO, ASTM and or ANSI) and ICH guidelines application preferred.
- Good communication skills within the analytical team, and other internal teams required. Must be able to work multiple tasks and projects simultaneously per business needs.
Qualifications
Education Required: Bachelor's Degree Preferred: Graduate Degree (Master's or PhD)
- 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.
- Master's Degree in Analytical Chemistry or related field is preferred along 1 year of industry experience.
- Ph.D degree in Analytical Chemistry, plus 0 year of industrial experience.
Certification(s): Specify preferred or required.
N/A
Computer Skills Required: Specify preferred or required.
Proficiency with Microsoft Word, Excel, and PowerPoint. Knowledge and experience with ChemStation/ OpenLab, Empower, VNMRJ, MNova, Agilent Microlab, Omnic or LIMS is required.
Other qualifications:
- 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.
- Knowledge of compendial methods (ie. USP, EP, ISO, ASTM and or ANSI) and ICH guidelines application preferred.
- 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.
Immediate Work Environment:
X Chemicals Unprotected Height X Fumes/Gases Persistent Noise
X PPE used: eye protection, nitrile gloves, lab coat
Work Activity: [must equal number of hours worked per day]
Stand: 3 Frequency: Intermittently Walk: 1 Frequency: Intermittently
Sit: 4 Frequency: Intermittently Drive: 0 Frequency: Choose an item.
Lift/Carry Demands
Frequency: Lift/Carry Equipment Provided:
0-10 lbs. Less than 1 hour a day Click or tap here to enter text.
11-25 lbs. Not Daily Cart
26-50 lbs. Rarely Click or tap here to enter text.
51-75 lbs. Never Click or tap here to enter text.
76-100 lbs. Never Click or tap here to enter text.
