Senior Scientist, Analytical Sciences

Job DescriptionJob Description

Welcome to DiscGenics, a pioneering, late-clinical stage biopharmaceutical company dedicated to advancing regenerative cell-based therapies for patients suffering from degenerative diseases of the spine. Privately held and passionately driven, our mission is to enhance lives by alleviating pain and restoring function through innovative treatment.

At DiscGenics, we are committed to improving the quality of life for individuals debilitated by degenerative diseases of the spine. Our focus lies in developing cutting-edge therapies that offer hope and tangible results, fostering a future where patients can regain mobility and comfort.

Our team is characterized by a relentless pursuit of excellence and a nimble approach to addressing challenges. Our core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship guide everything we do.

Join us at DiscGenics and be part of a transformative journey where your contributions have the potential to impact the lives of millions. Together we innovate with purpose and compassion, striving towards a future where pain and limitations of degenerative spine diseases are a thing of the past.

Discover more about us at discgenics.com and see how you can contribute to revolutionizing patient care through regenerative therapies.

Job Summary:

The Senior Scientist, Analytical Sciences is responsible to develop and qualify cell-based analytical methods and evaluate new analytical technologies. Also responsible to author and review method development reports, test methods, SOPs, protocols, supporting the technical review of CMC sections and supporting documents for regulatory filings. Must have industry experience in the development, qualification, and validation of cell bioassays (ELISA, Flow Cytometry, etc.) including experience with scale-up of methods to commercialization. Leads the collection and interpretation of data for biomarker and biological characterization assays including cell-based, multiplexed protein assays, and flow cytometry methods. Will work with manufacturing and quality control to develop tests, as well as analyze and author reports. Prepares technical reports, summaries, protocols and quantitative analyses.

This role interacts with all levels of the organization in a collaborative and positive way with colleagues to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values.

Essential Duties and Responsibilities:

• Manage strategic, SME, technical, and scientific development related to biological assays and other critical analytical methods.
• Advance and implement cell-based bioassay/potency and immunophenotyping by multi-parametric flow cytometry methods from conception through optimization, qualification, and method transfer to Quality Control and external partners as part of an analytical control strategy and to support Process Development.
• Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
• Work with Process Development, implementing and documenting analytical methods as part of experimental study plans to progress and characterize novel engineered cell therapy platforms.
• Work with Quality partners to draft study protocols, qualification reports, change controls, and occasionally perform routine assays as QC personnel for drug product release and characterization.
• Write, review, and edit accurate technical and development reports, CMC sections for regulatory submissions, and SOP/maintenance/user requirements for relevant equipment platforms.
• Provide technical guidance to junior staff, assign tasks, review data, and strengthen regulatory concepts (cGMP).
• Participate in group and department meetings, present scientific data, and provide expertise in areas of responsibility.
• Maintain, calibrate, and operate analytical equipment and instrumentation that is used in the execution of assays.
• Author quality records (change controls, deviations, investigations) to implement method changes and/or to investigate non-conformances, OOS/OOT, and CAPA.
• Author/contribute to other technical reports, including but not limited to comparability protocols/reports, risk assessments, and justification of specification, etc.
• Others duties as required.
  

Job Requirements:

• Demonstrated knowledge of Process Development or cellular therapy products and Analytical Method Development within a regulated environment.
• Experience with bioassay analytical science methods.
• Strong interpersonal, communication (verbal and written), and organizational skills.
• Independence and creative problem-solving abilities.
• Ability to handle highly confidential business information.
• Exceptional time management and multi-tasking skills.
• Team leadership skills and team player.
• Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Teamwork and Stewardship.
• Regular and predictable attendance.
• Ability to report to work responsive, free from sedatives, and in a non-sedative state.
• Proficient with Microsoft Office, including Word, Excel, and PowerPoint.

Education and Experience:

• Advanced degree in biological, biochemical, chemistry, cell-biology, or related field.
• 10+ years of relevant industry experience, preferable prior GMP roles for CMC.
• Experience with commercial development of pharmaceutical, biological or cell therapy product.
• First-hand experience in development and qualification of immunoassays, multi-parameter flow cytometry, and cell-based potency methods for release in a QC/regulated environment.
• Must have experience with scale-up to commercialization.

Working Conditions:

Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.

Must be able to lift and carry up to 20 pounds.

Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.

Disclaimer:

Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.