Process Development, Senior Manager

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.

Senior Manager Process Development - Parenteral Product & Process Development - Attribute Sciences

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Career Categories: Operations

Location: IE – Dun Laoghaire, Co. Dublin/remote

Live

What you will do

Let’s do this. Let’s change the world. As part of Amgen’s Process Development organization, Attribute Sciences (AS) continuously strives to be an analytical leader in support of delivering of superior, robust drug substance and product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial materials.  

Reporting to the Associate Director of Process Development-rare diseases, this person is accountable for managing analytical development and commercial maintenance of analytical methodologies. The scope of the role is to develop methods, support method related testing challenges, transfer methods between internal and external testing sites and trouble-shooting commercial testing issues which span various analytical platforms that  may include Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, recombinant proteins and recombinant PEGylated proteins.

Responsibilities also include supporting implementation of new analytical technology, DS and DP tech transfers, and functioning as an Attribute Sciences Team Lead. The successful candidate will be a part of a team at the interface with Quality, Manufacturing, Drug Substance and Drug Product Process Development, and Contract Manufacturing, liaising with the global Attribute Sciences network to ensure that programs are progressed. This role will laisse with Attribute Sciences functional leadership across Amgen.

Key Responsibilities:

• Provide scientific and technical leadership in support of troubleshooting method related testing challenges, incoming method transfer and development/commercial investigations. They will contribute to the strategic direction of the group to ensure timely project delivery, be aware of industry trends, future requirements and feedback from key partners.
• Implement and provide leadership for implementation of state-of-the-art and fit-for-purpose analytical methods for: in-process, release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions.
• Supporting ASTLs (May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation.
• Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities.
• Provide technical leadership to influence and execute strategy for analytical programs, life-cycle management, global regulatory submissions, and variation management for biologics and biosimilars.
• 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.
• Responsible to deliver against organizational goals and project milestones with a particular focus on analytical development and technology transfers and supporting new analytical technology implementation.
• 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 senior manager professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of experience in pharmaceutical/biotech process and product development and analytical method development.
• Master’s degree and 4 years of experience in pharmaceutical/biotech process and product development and analytical method development
• Bachelor’s degree and 8 years of experience in pharmaceutical/biotech process and product development and analytical method development

Preferred Qualifications:

• A Doctorate (Ph.D.) from an accredited college or university in one of the following areas: Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering or a related scientific discipline.
• 8+ years of pharmaceutical development experience.
• Demonstrated knowledge of analytical methods/technologies such as Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, recombinant proteins and recombinant PEGylated proteins.
• Demonstrated experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing. Understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.
• Understanding of drug substance and drug product manufacturing processes.
• 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.
• 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.
• Experience working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control.
• Experience with QbD and PAT, as applied to pharmaceutical development
• Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• 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. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

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.