This role will be responsible for optimizing, qualifying, and validating SEC, CE-SDS, DLS, and LC/MS based and related assays within the Analytical Sciences organization at Spark Therapeutics’ facility in Philadelphia, PA. Reports to the Analytical Lead Scientist.
The primary role of Analytical Scientist are: to lead the phase-appropriate optimization, qualification, verification and validation of analytical methods across the product development lifecycle from clinical to commercialization; provide support to QC in the investigation of non-conformances and troubleshooting method problems. Analytical scientist will also be responsible for developing new critical reagents for analytical methods, periodic review of analytical methods, and method performance trending and monitoring.
This position is responsible for optimizing, qualifying, and validating bio-separation assays for late-stage assets and trending analysis on method performance.
40% Execute experiments in support of CE, RP-HPLC, SEC-HPLC, IEX-HPLC, DLS, LC-MS and SDS-PAGE optimization, and validation with guidance from internal management.
30% Perform testing for product development, process characterization, and occasional release and stability. Qualify critical reagents and reference materials as needed.
10% Documents\Reviews test data generated within and outside the department. Ensures testing conforms to current methods, GMP, and SOP requirements.
10% Provide support to QC investigations through experimental design, data mining and analysis, problem solving and technical writing; Trend and report method performance data for bio-separation assay.
10% Perform laboratory equipment qualification, calibration and preventative maintenance program as needed. Maintain chemical and supply purchasing/inventory.
- BS/MS degree in the chemistry, biochemistry or related sciences with a minimum of 3+ years of experience in the Bio/Pharmaceutical industry or a PhD degree in chemistry, biochemistry or relates sciences with a minimum of 1 year of experience in the Bio/Pharmaceutical industry.
- Experienced in executing techniques such as HPLC, CE, LC/MS, particle size distribution, SDS-PAGE, physical, and compendial testing (Experience with Empower and 32 Karat preferred).
- Working knowledge of protein, DNA or RNA, virus-based assays.
- Experience in optimization and validation of bio-separation assays.
- Prior experience working in either a clinical development or commercial cGMP environment is preferred.
- The successful candidate must be a fast learner and should have attention to details.
- Strong laboratory skills with the ability to resolve and advise on technical issues of a moderate scope and develop new skills through on-the-job experiences.
- Detail oriented, well-organized, and capable of delivering on work assignments of moderate scope, given general instructions, where analysis involving multiple factors is required.
- Effective written and oral communication skills.
- Ability to work efficiently in a GMP environment while exercising judgement within defined procedures/practices to determine appropriate action.
- Flexible and comfortable with a fast-paced and evolving business environment.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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