Drug Product Associate Director

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Drug Product Associate Director

What you will do

Lets do this! Lets change the world!

The Associate Director will lead Amgens Drug Product new product introduction team in the Drug Product Technologies organization. Reporting to the Director of Amgen Thousand Oaks (ATO) Process Development this role will be responsible for managing teams of process engineering and process validation subject matter experts to ensure excellence of clinical and commercial technology transfers into the drug product manufacturing facility in Thousand Oaks. This management role will contribute to the strategic direction of the group based on emerging business needs industry trends and feedback from key stakeholders. This role will be based in Thousand Oaks CA. This role is primarily a firstshift role but may require some time on call during second or third shifts. Some US or international travel may be required to support Amgens drug product network.

Key responsibilities for this role include:

• Accountable for successfully executing all clinical and commercial tech transfers to Amgens drug product manufacturing facility in Thousand Oaks in an agile fashion

• Drive continuous improvement demonstrated by business process performance metrics

• Provide technical and management leadership to a team of engineers including peoplemanagers

• Manage and supervise a team of tech transfer leads responsible to assess facilitytoprocess fit during makeabatch exercise ensure transferability of offline characterization studies design and implement onsite characterization studies and process validation runs author/own high quality technical documents and regulatory files provide onsite support and evaluate product impact due to process scale equipment and raw material changes.

• Accountable for process validation of commercial products in alignment to applicable laws (FDA EU & global standards) and required policies and procedures including safety and training.

• Be a key contributor to regulatory filings throughout the authoring editing and submission process but also be responsible for responses to regulator questions as required and support PAI GMP inspections in the plant.

• Build and sustain excellent relationships with partners drug product teams NPI QA Supply Chain Process Development and manufacturing teams to ensure alignment between program needs and site capabilities.

• Accountable for building owning and maturing business processes to manage tech transfer portfolio for all drug product commercial tech transfers to the Thousand Oaks manufacturing facility in a tactical strategic and agile manner ensuring successful project completion and increasing team productivity and efficient use of available resources as demonstrated by performance metrics.

• Build maintain and improve tech transfer efficiency tools including utilization of offline characterization capabilities and predictive models development of templated documents implementation of lessons learned and more.

• Provide process development expertise for commercial drug product processing in specific areas such as sterile processing process characterization tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of deviations.

• Demonstrate a deep understanding of Amgens drug product and primary container platforms and support continuous evolution of platforms for agile tech transfers & improved manufacturability.

• Engage with the internal DP manufacturing network to guide the development and adoption of multisite practices and process improvements.

• Participate in site selection to provide technical fit of new product process requirements to manufacturing capabilities and a realistic account of resources for tech transfer.

• Deliver progress reports and presentations including generation and upkeep of dashboards to ensure management is aware of status and progress. Escalate issues recommendations on unresolved challenges in a professional and timely manner to the appropriate governance.

• Guide and mentor staff on daytoday performance long term career development and through change.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 14 years of Engineering or Process Development experience OR

• Associates degree and 12 years of Engineering or Process Development experience OR

• Bachelors degree and 9 years of Engineering or Process Development experience OR

• Masters degree and 7 years of Engineering or Process Development experience OR

• Doctorate degree and 3 years of Engineering or Process Development experience

• In addition to meeting at least one of the above requirements you must have a minimum of 3 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:

• Advanced Degree in Pharmaceutical Sciences Chemical Engineering Chemistry/Biochemistry Biotechnology Mechanical Engineering or a related field and 10 years of drug product process development experience in the pharmaceuticals/biotechnology industry.

• Knowledge of bringing new biotech products to market across various dosage forms and delivery systems and experience with process validation and marketing application regulatory filings.

• Technology transfer experience across different development phases fillfinish process scaleup and the use of gap analysis root cause analysis and risk assessment tools.

• Knowledge of aseptic processing and strong skills in applying fundamental engineering and scientific principles to the characterization of freeze/thaw formulation/mixing filtration filling lyophilization capping and visual inspection.

• Experience in cGMP manufacturing environment knowledge of cGMPs and other global regulatory requirements.

• Demonstrated ability in leading multifunctional teams to advance complex projects to completion and positively influence peers and executive leadership on decisionmaking.

• Project management skills including the ability to manage numerous projects and evaluate project resource requirements.

• Experience with building strong relationships in a matrix team environment collaborating with Process Development Project Management Manufacturing Regulatory Quality and Compliance.

• Ability to learn and act on dynamic information at a rapid pace and escalate relevant issues to management when required.

• Interpersonal and facilitation skills necessary to represent functional position and forge consensus among competing client interests while ensuring objectives are met.

• Strong focus on mentoring motivating and providing career and scientific/technical advice to staff.

• Demonstrated track record of taking initiative in identifying and implementing innovative approaches and ideas.

• Ability to think strategically to align and identify needs with incoming portfolio opportunities.

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 wellbeing. From our competitive benefits to our collaborative culture well 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 on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

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As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

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.

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