Senior Manager, Analytical Development

Company Overview:

Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space.

We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression.

Vividion was ranked #2 mid-size company on The San Diego Union-Tribune's 2022 Top Workplaces list.

Job Summary:

The Senior Manager of Analytical Sciences will support key CMC analytical activities for multiple projects and will work closely with CMOs and CROs. He/she will effectively deliver analytical data to the project teams and is responsible for the CMC sections of regulatory submissions, including QC. Additionally, this key contributor will be responsible for managing the stability program across all projects, including initiation and management of stability studies, protocol development and maintenance, data monitoring, trending and reporting. Moreover, this role directly interfaces with the CMC project team including QA and RA. A strong team player with the ability to communicate and collaborate in an interdisciplinary environment is essential.

Essential Duties and Responsibilities:

• Coordinate with project teams for retesting activities
• Determine expiry/retest periods for CTM, API, Reference Standards and other materials
• Manages or supports investigations, change controls and CAPAs as required.
• Communicate potential stability to the appropriate stakeholders.
• Maintains schedule of stability pulls, testing timelines, and reporting deadlines at CMO/CROs and ensures timely pulls per protocol.
• Acts as the analytical lead/support for both drug substance and drug product for one or more projects; interacts with CMOs/CROs and internal stakeholders enabling timely data delivery.
• Administers the stability database, organizes and maintains all stability protocols, files and associated data for all programs.
• Summarizes experimental findings, reviews and interprets study results, assembles analytical data packages, supports quality and regulatory teams to provide relevant documentation & draft sections of regulatory filings.
• Creates, reviews and/or approves stability study protocols; calculates sample quantities required for testing per study.
• Plans and coordinates analytical related studies. This includes the stability testing of development compounds and formulations, formulation development support.
• Maintains up-to-date knowledge of applicable industry/regulatory guidelines/requirements.
• Proposes and justifies specifications for drug substance and drug product.
• Reviews and approves analytical data, technical protocols/reports and analytical methods.
• Prepares accurate stability summary reports for CMC regulatory submissions, annual reports, and periodic updates to RA or QA.
• Maintains productive relationships with team leaders and contract organizations to ensure high quality data is shared and communicated effectively in a timely manner.
• Review stability data tables for compliance and trends. Performs expiry dating calculations to identify adverse trends; monitor and trend stability data to justify assigned product shelf life.
• Remain current with regulatory and industry requirements relevant to the stability program.
• Supports stability-related investigations.
• Manages analytical method development, validation, and transfer activities as well as extended characterization assays, including complex method development in collaboration with Chemical and Formulation Development team members.
• Collaborates with project teams to define stability commitments for study design, testing requirements and stability specifications, as appropriate.

Educational and Experience Requirements:

• Ability to interpret analytical data and draw conclusions.
• Minimum BS degree in a scientific discipline, preferably Analytical Chemistry with 8+ years of experience or MS with 6+ years of experience in the pharmaceutical/biotechnology industry, preferably within analytical development and quality control function in a GLP/GMP or FDA regulated environment.
• Previous stability management and analytical data review experience highly desired.
• Drafting of IND/IMPD and SOPs.
• Strong interpersonal, written, and verbal communication skills.
• Database administration experience and demonstrated knowledge of quality systems.
• A minimum of 3 years of experience managing CMOs or CROs.
• Experience with JMP, Slim Stat and/or other statistical/predictive software/applications.
• Able to analyze, summarize and present data to the stakeholders or decision makers.
• Demonstrated ability to work on multiple projects and meet timelines.
• Thorough knowledge of GLPs and GMPs as they relate to pharmaceutical development, including a good understanding of ICH quality guidelines.
• Experience working with and managing third party vendors.
• Knowledge of current analytical methodologies.

Pay & Benefits:

The annual base salary for this position ranges from $135,000 to $155,000 depending on relevant skills, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance. Relocation assistance may be available based on business needs and/or eligibility.

EEO & Employment Eligibility:

Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Privacy Policy:

The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit https://vividion.com/publication/privacy-noticeforcalifornia-candidates/.

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