Senior QC Biochemist

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are

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

Minimum 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

Preferred Qualifications

• 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

Job Location

This role is based at our Silver Spring, MD location.

The salary range for this position is $92,500 - $120,000 per year and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.