Senior QC Biochemist

United Therapeutics Corporation•Silver Spring, MD

1d•Onsite

About The Position

The Senior QC Biochemist is responsible for testing for all drug substances and drug products. This includes incoming, in-process, drug substance, APIs and finished product samples. Completion, review, and entry/confirmation of testing results and documentation for completeness, accuracy, etc. This individual will perform OOS and other investigational activities as required. They will be responsible for general administrative tasks supporting departmental tracking, training, and communication. They will ensure the timely and accurate testing of materials and product while maintaining and ensuring quality and compliance to meet the demands of production and R&D. Perform testing, process, and data analysis of samples in support of: instrument qualification; method verification and validation; process validation; in-process testing requirements; Product Development (PD), stability testing; and finished/release product testing Initiate and participate in the closure of Quality Events, CAPAs , Change Controls, Out of Specifications and Audit Findings assigned to the Quality Control department to support cGMP processes such as Investigations, Action Items, Effectiveness Checks, etc. Perform duties in support of raw materials, stability pulls, laboratory audits, and laboratory cleanliness Assist with report writing/review for annual/biannual commitments Perform instrument maintenance and calibration verification/standardization, as required Troubleshoot problems that arise and determine a resolution that can be proposed to management; Individual must be able to work with equipment manufacturer’s technical services to resolve issues Perform efficient and timely OOS investigations, as required Assist with process improvements, method development, method validation, and other activities for specified projects Write and review standard operating procedures (SOPs) for equipment operation, methods, and general laboratory procedures as needed Assist in the installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) of new laboratory equipment, as needed Prepare solvent mixture, buffers, and reagents, as needed Follow company SOPs and cGMP in the performance of all responsibilities Other duties as assigned

Requirements

Bachelor’s Degree in biochemistry or chemistry or other scientific discipline with equivalent experience/training
6+ years of experience in laboratory environment with at least 4 of those years in a QC environment
3+ years of experience in bioanalytical and analytical method development/validation
Proficiency in cGMP documentation and regulated laboratory practices, including use of electronic quality and data management systems (LIMS, TrackWise for deviations/change control, and MasterControl for training records)
Hands-on experience with capillary electrophoresis, HPLC, and UPLC, including use of 32 Karat software
Experience with biochemical and biological assays, including spectrophotometric methods, ELISA, and micropipetting
Experience performing compendial testing, supporting investigation writing, and participating in stability testing programs
Ability to work independently with minimal supervision and collaboratively in a team environment
Effective written and verbal communication skills
Ability to safely handle laboratory materials, reagents, and supplies and follow laboratory safety and chemical disposal procedures

Nice To Haves

Master’s Degree in biochemistry, chemistry or other scientific discipline with equivalent experience/training
3+ years of experience in Instrumentation experience in different types of detection techniques in capillary electrophoresis such as UV, PDA and Fluorescence
Working knowledge of FDA and USP testing requirements
Proficiency in Microsoft Word, Excel, and chromatography/data analysis applications
Strong analytical, problem-solving, and critical thinking skills with the ability to prioritize work and meet aggressive timelines

Responsibilities

Perform testing, process, and data analysis of samples in support of: instrument qualification; method verification and validation; process validation; in-process testing requirements; Product Development (PD), stability testing; and finished/release product testing
Initiate and participate in the closure of Quality Events, CAPAs , Change Controls, Out of Specifications and Audit Findings assigned to the Quality Control department to support cGMP processes such as Investigations, Action Items, Effectiveness Checks, etc.
Perform duties in support of raw materials, stability pulls, laboratory audits, and laboratory cleanliness
Assist with report writing/review for annual/biannual commitments
Perform instrument maintenance and calibration verification/standardization, as required
Troubleshoot problems that arise and determine a resolution that can be proposed to management; Individual must be able to work with equipment manufacturer’s technical services to resolve issues
Perform efficient and timely OOS investigations, as required
Assist with process improvements, method development, method validation, and other activities for specified projects
Write and review standard operating procedures (SOPs) for equipment operation, methods, and general laboratory procedures as needed
Assist in the installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) of new laboratory equipment, as needed
Prepare solvent mixture, buffers, and reagents, as needed
Follow company SOPs and cGMP in the performance of all responsibilities
Other duties as assigned