Analytical Development Lead Scientist

Job Description

Job Description

The Company

Our client is a biotechnology company developing a novel Virus-inspired Particle (ViP) platform delivery technology that can be used to treat multiple diseases.

Their lead program is in Oncology, whereby they redirect immune memory against pathogens to target cancer. The targeting of tumors stems from the ViP being specific to a tumor-associated heparin sulfate chain that is expressed across many tumors, making it a potential treatment for a wide variety of solid tumors. This highly novel and differentiated approach has allowed the company to foster partnerships with Janssen Biologics (J&J) and Fosun Pharmaceuticals.

Beyond Oncology, our client is looking into other areas of high unmet needs such as immunological disorders due to extra-cellular matrix remodeling / changes.

Summary of Position Analytical Development Lead Scientist

We are looking for a highly motivated, focused, and enthusiastic individual who is looking to take on a position of growth in Analytical Development (AD). This AD Scientist I / II position is a lead technical position reporting directly to the Head of CMC. He / she will be responsible for leading all aspects of AD specifically physicochemical and biological assay development, qualification (with vendors), method transfer, and full lifecycle support of analytical release and stability methods for biologic products using a variety of scientific processes and methodology for our recombinant ViP therapeutic platforms. On a day-to-day basis, this individual will be expected to work closely with the in-house CMC team and external contractors on different quality functions in a results-driven, collaborative environment. He / she will be responsible for the choice of experimental methodology, carrying out the analyses, and providing interpretations and conclusions from the results for each project in a timely fashion. In addition, he / she is expected to train cross-functionally carry out the drug substance process, and contribute to the team on an as-needed basis.

How will you contribute to VerImmune and grow

This is an exciting opportunity to drive the development of the next generation of oncology treatment modalities. As a lead AD Scientist, you will be given leadership opportunities to oversee the method development, qualification, and validation from early pre-clinical development to first in human clinical trials. You will be the lead in-house analytical expert to guide and oversee CDMOs that will manufacture GMP Drug Substances and Drug Products for the clinical studies. This is a highly collaborative position of growth that will require translational partnering with Non-clinical sciences, Regulatory, Clinical, Quality, and Business Development.

Core Responsibilities

With the Head of CMC, the CMC Team, the CMC advisory team, and other cross-functional teams,

• Develop or optimize analytical release and stability methods including
• Chromatography (size exclusion, ion exchange, reversed phase, hydrophobic interaction, etc.)
• Light scattering based (Dynamic Light Scattering) and electrophoretic methods (capillary gel electrophoresis, isoelectric focusing) for biological pipeline programs to support the technical development of the molecules towards commercialization.
• Binding-related e.g. Cell-based bioassays or ELISA and cytotoxicity assays
• Support method lifecycle through qualification and method transfer to the quality group.
• Perform comparability evaluations of product quality and stability to support drug substance and drug product process changes.
• Support setting of clinical and commercial specifications of pipeline molecules, in collaboration with quality function.
• Participate in Critical Quality Attribute Assessments by leading, conducting, and / or supporting forced degradation studies and impurity characterization studies.
• Supervise operation and maintenance of analytical instrumentation (e.g. HPLC, UPLC, CE, etc.) and procedures as part of efforts to develop a robust analytical method control strategy.
• Perform analyses to support release and lead lot stability of pipeline programs including drug pre-clinical toxicology animal study batches.
• Support product quality assessment during fermentation, purification development, formulation development, and process characterization efforts from early to late stages.
• Provide technical troubleshooting for manufacturing / quality investigations
• Support the application of new cutting-edge technologies to improve method performance and throughput.
• Author and review technical reports summarizing the method development, qualification, and robustness results and other technical documentation including standard operating procedures for method transfer to quality group as well as guideline documents for implementing best practices.
• Serve as a role model, and provide coaching and mentoring to junior staff to maximize productivity and effectiveness.
• Serve as an analytical resource for the department and project teams, proactively keeping colleagues updated with current scientific trends and technical aspects from conferences, local meetings, and the literature.
• Cross-train on the upstream and purification process and be able to perform runs as needed basis to support the process team.
• Stay up-to-date with the current FDA and ICH guidelines regarding analytical methods.
• Present scientific findings at internal and external meetings and author scientific journal publications.
• Author regulatory filings to the FDA and other health agencies as needed.

Who you are

The ideal candidate is a well-organized and self-motivated individual who is driven by the creation of new initiatives, innovates within their domain of expertise, and is excited by interdisciplinary collaboration. A high level of responsibility and urgency with a drive for results, flexibility, and adaptability to constructive guidance is required to carry out the diverse duties of this position.

Required Knowledge, Skills, Abilities

Qualifications

Education & Experience

Preference will be given to candidates with :

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Type : Full-time