QC Sr. Scientist

Join the Spark Team

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.

We don't follow footsteps. We create the path.

This role will be responsible for assisting optimizing, qualifying, and validating SEC, CE-SDS, DLS, and LC/MS based and related assays within Quality Control organization at Spark Therapeutics' facility in Philadelphia, PA. Reports to the Bioassay Lead.

The primary role of Senior 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. Sr. 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.

Responsibilities

% of Time

Job Function and Description

50%

• Design and 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. Draft method-specific development reports and SOPs.

20%

• Perform testing for product development, process characterization, and occasional release and stability. Qualify critical reagents and reference materials as needed.

10%

• DocumentsReviews test data generated within and outside the department. Ensures testing conforms to current methods, GMP, and SOP requirements.

10%

• Provide support to complex QC investigations through experimental design, data mining and analysis, problem solving and technical writing.

10%

• Perform laboratory equipment qualification, calibration and preventative maintenance program as needed. Maintain chemical and supply purchasing/inventory.

Education and Experience Requirements

• BS/MS degree in the chemistry, biochemistry, or related sciences with a minimum of 5+ 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.
• Provide guidance to the technical team and troubleshooting of assays are desirable.
• Experience in optimization and validation of bio-separation assays.
• Prior experience working in either a clinical development or commercial cGMP environment is preferred.
• Knowledge of ICH, USP, JP, and EP guidelines for phase appropriate method validation

Key Skills, Abilities, and Competencies

The successful candidate must demonstrate the following:

• Strong scientific and laboratory skills, with the ability to resolve and advise on technical issues of a moderate scope and develop new skills through on-the-job experience.
• Detail oriented and 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
• The Interpersonal skills to successfully collaborate with other groups.
• 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

Complexity and Problem Solving

The position requires the following, with respect to Problem Solving:

• The ability to identify, resolve, and/or advise on technical issues of moderate scope related to separation-based methods.
• The ability to carefully document experiments in a notebook, draw conclusions, and present path forward.
• This position will advise and/or propose experimental design for Reference Standard characterization and qualification studies. Meticulous, 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.

Internal and External Contacts

• This position reports to, Bioassay lead of Quality Control.
• This position will acquire training from and provide training to QC Operations personnel.
• This position will communicate with contract testing labs, as appropriate.
• This position will communicate with personnel from other Spark departments to provide project updates, as appropriate.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.