Director, Commercial Drug Products & Life Cycle Management

Amgen•Cambridge, MA

About The Position

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.

Requirements

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
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

Nice To Haves

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

Responsibilities

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.

Benefits

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

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