Director, Commercial Drug Products & Life Cycle Management

Director, Commercial Drug Products & Life Cycle Management page is loaded## Director, Commercial Drug Products & Life Cycle Managementremote type : Flex Commuter / Hybridlocations : US - Massachusetts - Cambridge : US - California - Thousand Oakstime type : Full timeposted on : Posted Todayjob requisition id : R-225558##

• Career Category
• Process Development## ##
• Job Description
• Join Amgen’s Mission of Serving Patients
• At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
• Director, Commercial Drug Products & Life Cycle Management
• What you will do
• Let’s do this. Let’s change the world. In this vital role you will be part of Amgen’s Process Development organization, Drug Product Technologies unit that continuously strives to be a technical leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team leaders (DPTLs) play a central role in this process by serving as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation, integrated development of combination products, process improvements, life cycle changes, regulatory submissions, annual product reviews, etc. DPTLs are part of an integrated operations team and lead a technical team responsible for delivering drug product process transfers, process optimization, process trouble shooting, timely closure of non-conformance investigations and change control assessments to ensure supply of commercial drug products. We are seeking a director to lead an impactful team of DPTLs responsible for all commercial drug product programs in our portfolio.
• Provide scientific, technical and managerial leadership in support of commercial drug product and life cycle management activities.
• Lead a team of highly skilled scientists and engineers with advanced degrees and training and lead the strategic direction of the group to ensure contract book deliverables for the portfolio, aware of industry trends, future requirements and feedback from key partners.
• Provide technical leadership to influence and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, biosimilars, and oral dosage forms.
• Maintain strong partnerships with product delivery team leaders in Operations, Therapeutic Area heads, all Process Development groups, Regulatory, Quality and with Clinical and Commercial manufacturing sites to positively influence Amgen practices and strategies to ensure success through the life cycle of current and future commercial products.
• Advance the organization’s competence on GMP compliance, current regulatory trends and expectations.
• Actively direct and lead team capacity / resources, budget targets, timelines.
• Talent management responsibilities including hiring, leadership development, mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment.
• Recruit and retain technical staff that can deliver in a highly matrixed and dynamic environment.
• Up to 25% travel to domestic and international sites.
• What we expect of you
• We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
• Basic Qualifications :
• Doctorate degree and 4 years of experience in engineering, science, or business management
• Or
• Masters degree and 8 years of experience in engineering, science, or business management
• Or
• Bachelors degree and 10 years of experience in engineering, science, or business management
• And
• In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and / or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
• Preferred Qualifications :
• PhD from an accredited college or university in one of the following areas : Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area
• 10+ years of pharmaceutical development and management experience
• 10+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization
• Demonstrated knowledge of drug product commercialization and integrated combination product development
• Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites
• Strong knowledge about developing processes with single-use manufacturing equipment
• Implements with a sense of purpose and drives course corrections where appropriate
• Excellent written, verbal, and presentation skills - ability to distill, craft and present key messages relative to diverse audience requirements
• Knowledge of applicable global regulatory requirements. Experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters
• Strong problem solving, trouble shooting, and communication skills
• Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment to lead change, efficiency, and strong cross functional relationships
• Hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems
• Superior knowledge of aseptic processing and manufacturing of injectable drugs in vials, syringes, cartridges, devices, disposables, and the associated GMP / Device documentation and regulatory filings
• Experience with biologics and oral dosage form manufacturing is critical
• Advanced understanding of primary containers (syringes, cartridges and vials), elastomer, polymer (injection and extrusion blow molding), formulation, technical modeling of complex systems, labeling and packaging, cold chain expertise
• Strong focus on coaching, motivating and providing career and scientific / technical advice to staff
• Strong networking skills to work across organizations to advance innovated processes, approaches and methodologies
• What you can expect of us
• As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based

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