Amgen Director, Commercial Drug Products & Life Cycle Management in Cambridge, Massachusetts
As part of Amgen’s Process Development organization, Drug Product Technologies unit 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 a high-performing team of DPTLs responsible for all commercial drug product programs in our portfolio.
The director of this team will provide scientific, technical and managerial leadership in support of commercial drug product and life cycle management activities. She/he will manage a team of highly skilled scientists and engineers with advanced degrees and training and will contribute to 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. The primary focus of this group is to provide technical leadership to influence and execute strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, biosimilars, and oral dosage forms. As a key contributor to Amgen’s commercialization process, the director must 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. Actively direct and manage team capacity/resources, budget targets, timelines, etc. Advance organization’s acumen on GMP compliance, current regulatory trends and expectations. Fulfill talent management responsibilities for technical personnel including hiring, leadership development, mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment. Recruit and retain highly capable staff that can deliver in a highly matrixed and dynamic environment.
This position requires (up to 25%) travel to domestic and international sites
Doctorate degree and 4 years of experience in engineering, science, or business management
Masters degree and 8 years of experience in engineering, science, or business management
Bachelors degree and 10 years of experience in engineering, science, or business management
4 years of managerial experience directly managing people and/or leadership experience leading commercial teams, high impact initiatives, programs and directing the allocation of resources.
A Doctorate (Ph.D.) 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 discipline
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
Executes 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
Established 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 team environment to drive 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 essential
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 methodologiesAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.