Senior Analytical Chemist

Tri-Pac•South Bend, IN

6d•Onsite

About The Position

Hubot Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced Senior Analytical Chemist for immediate addition to our fast-growing team. The Analytical Chemist maintains a working knowledge of all Tri-Pac procedures, customer procedures and requirements, and follows Good Manufacturing Processes (GMP) and GLP. This individual must have good interpersonal skills with a collaborative team attitude that is customer focused, and quality driven.

Requirements

Experience with Medical Devices and/or OTC consumer products
Lab Instrumentation including GC, HPLC, FTIR
GMP, GLP, LIMS
Strong analytical skills with experience using HPLC, GC and other lab equipment

Responsibilities

Independently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV, IR, titration) of analysis for excipients, new chemical entities, drug products and stability samples
Independently perform method evaluation/development/validation/verification and troubleshooting instruments and improvement of processes
Support Cleaning Validation method development and sample testing.
Interpret data and make recommendations to management for improvement or potential concerns
Compare laboratory data against specifications, prepare reports, and trend data where applicable to determine if results meet requirements
Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation
Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations
Independently author standard operating procedures, analytical testing procedures, batch release testing forms, and create document templates for use by junior team members
Create report templates and/or enter data into established reports/templates or software-based systems
Review routine laboratory experiments for accuracy and provide guidance to junior team members to ensure future compliance
Identify and recommend opportunities for improved efficiencies, internal/external client service and teamwork within the analytical group
Serve as a point of contact for laboratory testing support and provide updates to laboratory supervision and/or client
With supervision, support the scheduling and planning of internal/external client project work to ensure the highest levels of efficiency and quality standards are met
Support the development of a quality environment by driving and monitoring quality standards within the team
Become resident expert in the use of LIMS (perform supervisory sign-off for electronic reports) and other software-based systems
Serve as a method troubleshooting resource to identify and document critical factors that affect method performance and assist peers in resolving method issues in a timely, cost-effective manner
Assist laboratory management with the preparation and execution of laboratory investigations/deviations and CAPA.
Mentor and train new laboratory team members