Director Process Development

HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Director, Process Development 
Location: IE – Dun Laoghaire, Co. Dublin

Live
What you will do
Let’s do this. Let’s change the world. As part of Amgen’s Process Development organization, Drug Product Technologies (DPT) 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.

Reporting to the Executive Director of ADL Process Development, this person is accountable for leading a process development team responsible for providing commercial drug product manufacturing support and executing Technology Transfer/New Product Introduction (NPI) onto existing and new vial and syringe manufacturing lines at Amgen Dun Laoghaire (ADL). The scope of the role is to lead a team of senior managers, and subject matter experts (SME’s) to provide technical support for the main unit operations of drug product manufacturing; formulation, filling into vials/syringes, lyophilization, capping and inspection operations – who will be using this knowledge to support manufacturing, execute new tech transfers, new product introductions, drive process improvements, characterize new filling lines or manufacturing technologies, author/review CMC regulatory sections in global filings, and support regulatory audits/inspections. 

Key Responsibilities:
•    Provide scientific, technical and managerial leadership in support of commercial drug product NPI/Tech Transfer and life-cycle management activities. They 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 project delivery, product portfolio contract book delivery, aware of industry trends, future requirements and feedback from key partners.
•    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 parenteral drug products. 
•    Maintain strong partnerships with global network stakeholders e.g., Product Delivery Teams (PDT’s), all Process Development groups, Regulatory, Quality and sister 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.
•    Responsible to deliver against organizational goals and project milestones with a particular focus on providing commercial manufacturing support, and/or NPI/LCM technology transfers, supporting new drug product technology implementations.
•    Advance digital upskilling of the team, steer the team towards a culture of data driven insights, and driving efficiency with the use of novel digital AI tools
•    Accountable for developing recommendations on potential paths forward and the clear communication of those recommendations and their rationale to appropriate governance including risks of those paths and the risks of alternate pathways.
•    Accountable for devising mitigation strategies for risks of final project pathway chosen.
•    Escalate issues, recommendations, and/or unresolved decisions in a professional and timely manner to the appropriate governance. Ensures that all appropriate groups are represented for decisions that need to be made.
•    Holds others responsible or answerable for their actions, for exemplary job performance, and achieving business results.
•    Actively communicates across functions and sites and is a strong collaborator with all the functional groups at site.
•    Moderate international travel might be required (up to 15% of the time).

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Director level professional we seek is a leader with these qualifications.

Basic Qualifications:
•    Doctorate degree and 4 years of experience in Engineering, Science or Business Management.
•    Master’s degree and 8 years of experience in Engineering, Science or Business Management.
•    Bachelor’s degree and 10 years of experience in Engineering, Science or Business Management.
•    Four (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.

Preferred Qualifications:
•    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 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, devices, disposables, and the associated GMP/Device documentation and regulatory filings.
•    Experience with parenteral drug product processes and technology transfers manufacturing is essential.
•    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.

Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. 
•    Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent.
•    Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
•    Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. 

Amgen focuses on areas of high unmet medical need and uses 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 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, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.