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Salesforce, Inc.
San Francisco, CA, United States
Salesforce.com Inc's Candidate Privacy Notice contains more details about the handling and use of the personal data of job applicants. For more information about our website privacy practices, please see our Privacy Statement. Operations Program Manager page is loaded Operations Program Manager Apply remote type Office - Flexible
Job Source: Salesforce, Inc.Zoox
Foster City, CA, United States
The Operations Program Manager is a supply chain-focused operations role that supports development and production of complex module assemblies at supplier sites in order to ensure on-time development and delivery of products. They will manage the overall production readiness at a given point in the supply chain, including resource allocation, produ
Job Source: ZooxAnthropic Limited
San Francisco, CA, United States
About the role: We are seeking an experienced Program Manager to drive strategic cross-functional initiatives vital to Anthropic's growth. This collaborative leader will partner across the organization to scope new programs, facilitate operational planning, and execute project work. As a key point of contact for internal and external partners, yo
Job Source: Anthropic LimitedAtlassian
Mountain View, CA, United States
Overview: Working at Atlassian Atlassians can choose where they work whether in an office, from home, or a combination of the two. That way, Atlassians have more control over supporting their family, personal goals, and other priorities. Interviews and onboarding are conducted virtually, a part of being a distributed-first company. This role is av
Job Source: AtlassianZoox
San Mateo, CA, United States
The Operations Program Manager is a supply chain-focused operations role that supports development and production of complex module assemblies at supplier sites in order to ensure on-time development and delivery of products. You will manage the overall production readiness at a given point in the supply chain, including resource allocation, produc
Job Source: ZooxJewish Vocational Service
San Francisco, CA, United States
Why Join JVS? JVS is a nonprofit working to close opportunity gaps in employment by supporting jobseekers with the skills and confidence to secure quality careers with family-sustaining wages. Grounded in core values of racial equity and focused on helping our program participants achieve economic mobility, we believe everyone deserves access to t
Job Source: Jewish Vocational ServiceWilliam and Flora Hewlett Foundation
Menlo Park, CA, United States
The William and Flora Hewlett Foundation, based in Menlo Park, California, seeks a Program Operations Manager for its Environment Program. About the foundation The William and Flora Hewlett Foundation invests in creative thinkers and problem solvers working to ensure that people, communities, and the planet can flourish. Together with our partne
Job Source: William and Flora Hewlett FoundationScale AI
San Francisco, CA, United States
Scale is at the forefront of enabling Machine Learning across multiple industries including self driving cars. As one of Scale's Operations Program Manager, you'll be running solutions, tools, and processes to ensure timely delivery of our services while maintaining the highest quality standards. We are growing operations rapidly, on-boarding new
Job Source: Scale AISan Mateo, CA, United States
Development Program and Operations Manager
Department: Drug Development
Employment Type: Full Time
Location: San Mateo, CA
Description
The Role: We are seeking a talented and experienced Program Manager with extensive expertise in biologics cGMP and Chemistry, Manufacturing, and Controls (CMC). The ideal candidate will also have strong leadership skills and broad experience in program management of IND enabling activities and outsourced biologics manufacturing. This individual will play a pivotal role in organizing and structuring the Development team at BigHat, leading strategic initiatives for the Development organization, and driving the advancement of our biologics pipeline from discovery through clinical development.
Key Responsibilities
Discovery Stage Program Management:
Provide PM support to early-stage research programs to enable smooth progression through discovery, lead optimization, candidate selection and preclinical development.
Organize and coordinate cross-functional discovery stage project teams, facilitating communication and collaboration between Research, Development, and other functional groups.
Program Management of CMC and IND enabling activities:
Organize and manage CMC project teams to drive outsourced manufacturing of biologics drug candidates, ensuring alignment with project timelines and objectives.
Organize and manage project teams conducting outsourced studies to support IND submissions.
Coordinate activities between key development functions including Quality Assurance, Toxicology, Clinical Manufacturing and Drug Supply.
Collaborate closely with internal teams and external partners including CROs/CDMOs, SMEs and consultants to ensure efficient prosecution of manufacturing and other IND enabling activities.
Facilitate program decisions to ensure they are made with input from key stakeholders.
Act as a liaison between internal teams and external partners/vendors to coordinate project activities and deliverables.
Support and track the preparation of regulatory submissions, including IND filings.
Identify potential risks and challenges related to CMC development and propose mitigation strategies to minimize impact on project timelines and quality.
Operations Management:
Build and maintain internal CMC/GMP systems and business processes.
Define roles and responsibilities of key staff positions such as Product Technical Leads.
Identify, propose, and support solutions for a range of organizational and operational challenges.
Lead initiatives to optimize development team culture, and staff development.
Ensure compliance with regulatory requirements and industry standards for CMC development, including FDA, EMA ,and ICH guidelines.
Prepare regular progress reports and presentations for internal stakeholders and external partners/investors.
Develop and maintain a structure for accurate and comprehensive organization of CMC documents, including development reports, batch records, and regulatory filings.
Maintain records of relevant communications within internal project teams and with external CDMOs.
Skills Knowledge and Expertise
Bachelor's, Master's, or Ph.D. degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Chemical Engineering, Biotechnology).
Five or more years of experience managing CMC activities within the biotech or pharmaceutical industry, with a focus on biologics.
Understanding of cGMP CMC principles and processes, including process development, analytical characterization, and manufacturing.
Experience managing tech transfer of CMC manufacturing and/or analytics.
Excellent communication, organizational, and leadership skills.
Ability to work effectively in a fast-paced, entrepreneurial environment and adapt to changing priorities.
Experience with biologics drug development, including monoclonal antibodies, and/or recombinant proteins.
[Preferred] Familiarity with regulatory requirements for cGMP, CMC development, including FDA, EMA and ICH guidelines.
[Preferred] Familiarity with discovery stage processes and experience with program management of early discovery projects.
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Email Alert for Development Program and Operations Manager jobs in San Mateo, CA, United States
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