We have other current jobs related to this field that you can find below
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Associate Director, Clinical Contracts
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Hayward, United States Eikon Therapeutics Full timeEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...
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Clinical Director
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Clinical Director
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Associate Director, Clinical Scientist
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Associate Director of Outpatient
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Director, Trial Master File Operations
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Director (Head), Clinical Scientist - Oncology
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Associate Director of Outpatient
2 months ago
Hayward, California, United States Horizon Services, Inc. Full timeJOB TITLE: Associate Director of Outpatient & Prevention Program Operations LOCATION: Project Eden Who are we? Horizon Services, Inc. (HSI) is a nonprofit established in 1974 offers addiction treatment with the goal of reducing substance use related challenges for people from all walks of life, including those from some of the most disenfranchised and...
Director of Clinical Operations
2 months ago
Avirmax Inc. based in the SF Bay Area, is a clinical stage biopharma specializing in development of rAAV-based gene therapeutics for ocular diseases. The company is dedicated to develop the state-of-the-art technologies to address current challenges residing in rAAV mediated gene therapeutics of ocular diseases and production.
Responsibilities
· Develop and maintain the overall quality assurance strategy and quality system for the clinical manufacturing.
· Provide quality assurance oversight throughout the development of a product to clinical stages and ensure quality requirements and current regulatory requirement appropriate for clinical phases
· Manage and oversee all QA activities, including quality agreement, audit and inspection, documentation, deviation and CAPA management, change control, vendor qualification, method validation/transfer, risk assessment, clinical product release and stability
· Support activities for releasing or rejecting raw materials, intermediates, and drug substance/drug product batches by coordinating in-house and out-sourced analytics.
· Support manufacturing in facility and equipment qualification, process control, training programs
· Prepare/review/approve GMP related documents (SOPs, qualification protocols/reports)
· Utilizes technical and scientific knowledge to support technical transfer of manufacturing processes and analytical methods
· Lead multi-functional discussions during the course of significant investigations and root cause Investigations for potential product quality impact to ensure safety and quality of drug product for clinical trials
· Prepare, review, approve and manage of quality assurance agreements with contract manufacturers/testing laboratories, suppliers of service providers, or clients for investigational products and other development projects
· Assist in preparation and review of regulatory submissions in CMC section for IND and pre-IND filings
Skills and Experience:
· Bachelor’s degree or higher in life/health sciences or related technical field.
· Minimum 10+ years of relevant experience in drug development or quality system in a biopharmaceutical industry, with a minimum of 3 years of project management or functional team lead experience required.
· Strong knowledge of and direct experience with GMP requirements. Familiar with Chemistry, Manufacturing and Control (CMC) and Quality Assurance (QA) operations. Ability to apply cGMPs for biologics manufacturing in a phase appropriate, and compliant manner.
· Experience with regulatory filings (including IND and pre-IND submissions).
· Project management skills in detailed project plans, prioritize tasks, status update and project progress to achieve project goals.
· Excellent written and oral communication and interpersonal skills, as well as strong planning and organizational ability are required. Detail oriented with strong organizational skills. Demonstrated success in scientific/technical proficiency, collaboration and leadership skills, and independent thinking.
· Action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions.
· Self-motivated individual with a desire to work in a startup environment and able to work onsite.
