RF TECHNOLOGIES INC
Director Process Development - Pivotal Biologics, Drug Product Technologies
RF TECHNOLOGIES INC, Thousand Oaks, California, United States, 91362
Director Process Development - Pivotal Biologics, Drug Product Technologies in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.Director Process Development: Pivotal Biologics - Drug Product TechnologiesWhat you will doIn this vital role as a Director within the Pivotal Biologics group in Drug Product Technologies, you will provide scientific, technical, and managerial leadership in support of late-stage biologic drug product development. The role, based at the Thousand Oaks, CA site, will manage a team of process and formulation experts in the simultaneous development of multiple products within Amgen’s portfolio. You will be a member of the Pivotal Biologics leadership team and contribute to the strategic direction of the group, responding to industry trends, future business requirements, and inputs from key partners.Group Scope:Development of commercial formulations and drug product processes for products that span Amgen’s biologics pipeline, including new constructs, biosimilars, and lifecycle management opportunities within the commercial portfolio.Technology transfer to clinical manufacturing and process characterization.Technology transfer to commercial manufacturing and authoring of the marketing application and responses to agency questions.Advancement of novel technology and capabilities that can increase throughput and capacity and/or reduce development cycle time.Generation, maintenance, and application of efficiency enabling formulation and process platforms.Responsibilities Include:Lead a high-performing technical team, fostering diversity in scientific and engineering skills.Interface seamlessly with partners in Process Development, Quality, Regulatory, and Manufacturing to optimize drug product development.Provide visionary leadership in devising strategies and experimental plans for drug delivery, emphasizing biological efficacy, ease of administration, and enabling target product presentations.Efficiently organize and leverage resources for maximum output while fostering innovation.Develop and communicate a compelling department vision, aligning each team member's work with the broader organizational goals.Provide input on program strategy, budgets, timelines, and project plans. Ensure the management and fulfillment of technical and business requirements.Navigate ambiguity and rapid changes adeptly, smoothly transitioning and rallying the team when needed.Guide and mentor team members in day-to-day performance, long-term career development, and during times of change.Possess expertise in process engineering, pharmaceutical sciences, formulation development, and drug delivery technologies.Regularly engage with senior management and executives, shaping comprehensive departmental direction.Contribute to regulatory filings, including INDs, CTAs, and MAs; assist in addressing regulatory authorities' inquiries as needed.Rigorously review all scientific and regulatory deliverables.Demonstrate flexibility for domestic and international travel, up to 10% of the time.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Process Development professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree and 4 years of Process Development experienceORMaster’s degree and 8 years of Process Development experienceORBachelor’s degree and 10 years of Process Development experienceIn addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.Preferred Qualifications:Doctorate degree in one of the following areas: Biology, Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering, or a related scientific discipline.10+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization.10+ years of management experience.Demonstrated knowledge of drug stability assessment and mitigation strategies.Demonstrates people-centered leadership in all interactions.Strong focus on mentoring, coaching, motivating, and providing career and scientific/technical advice to staff.Strong networking skills to work across organizations to advance innovative processes, approaches, and methodologies.Excellent written, verbal, communication, and presentation skills.Established knowledge of applicable global regulatory requirements and experience preparing technical sections of regulatory submissions.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.Apply nowfor a career that defies imaginationJoin us.careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process.
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HOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.Director Process Development: Pivotal Biologics - Drug Product TechnologiesWhat you will doIn this vital role as a Director within the Pivotal Biologics group in Drug Product Technologies, you will provide scientific, technical, and managerial leadership in support of late-stage biologic drug product development. The role, based at the Thousand Oaks, CA site, will manage a team of process and formulation experts in the simultaneous development of multiple products within Amgen’s portfolio. You will be a member of the Pivotal Biologics leadership team and contribute to the strategic direction of the group, responding to industry trends, future business requirements, and inputs from key partners.Group Scope:Development of commercial formulations and drug product processes for products that span Amgen’s biologics pipeline, including new constructs, biosimilars, and lifecycle management opportunities within the commercial portfolio.Technology transfer to clinical manufacturing and process characterization.Technology transfer to commercial manufacturing and authoring of the marketing application and responses to agency questions.Advancement of novel technology and capabilities that can increase throughput and capacity and/or reduce development cycle time.Generation, maintenance, and application of efficiency enabling formulation and process platforms.Responsibilities Include:Lead a high-performing technical team, fostering diversity in scientific and engineering skills.Interface seamlessly with partners in Process Development, Quality, Regulatory, and Manufacturing to optimize drug product development.Provide visionary leadership in devising strategies and experimental plans for drug delivery, emphasizing biological efficacy, ease of administration, and enabling target product presentations.Efficiently organize and leverage resources for maximum output while fostering innovation.Develop and communicate a compelling department vision, aligning each team member's work with the broader organizational goals.Provide input on program strategy, budgets, timelines, and project plans. Ensure the management and fulfillment of technical and business requirements.Navigate ambiguity and rapid changes adeptly, smoothly transitioning and rallying the team when needed.Guide and mentor team members in day-to-day performance, long-term career development, and during times of change.Possess expertise in process engineering, pharmaceutical sciences, formulation development, and drug delivery technologies.Regularly engage with senior management and executives, shaping comprehensive departmental direction.Contribute to regulatory filings, including INDs, CTAs, and MAs; assist in addressing regulatory authorities' inquiries as needed.Rigorously review all scientific and regulatory deliverables.Demonstrate flexibility for domestic and international travel, up to 10% of the time.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Process Development professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree and 4 years of Process Development experienceORMaster’s degree and 8 years of Process Development experienceORBachelor’s degree and 10 years of Process Development experienceIn addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.Preferred Qualifications:Doctorate degree in one of the following areas: Biology, Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering, or a related scientific discipline.10+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization.10+ years of management experience.Demonstrated knowledge of drug stability assessment and mitigation strategies.Demonstrates people-centered leadership in all interactions.Strong focus on mentoring, coaching, motivating, and providing career and scientific/technical advice to staff.Strong networking skills to work across organizations to advance innovative processes, approaches, and methodologies.Excellent written, verbal, communication, and presentation skills.Established knowledge of applicable global regulatory requirements and experience preparing technical sections of regulatory submissions.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.Apply nowfor a career that defies imaginationJoin us.careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process.
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