Associate Director Process Development

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 164,000 - 222,000; Full time

Job summary

Amgen Inc. in Thousand Oaks seeks an Associate Director to lead commercial drug product programs and a scientific team in formulation, aseptic design and process development for parenteral and solid dosage forms.

You will drive technology transfers, lifecycle changes, and regulatory submissions while coaching staff and collaborating with clinical and commercial operations to ensure reliable product supply.

Qualifications

• PhD or equivalent in a relevant scientific discipline with leadership credentials.
• Extensive pharmaceutical development and lifecycle management expertise.
• Experience in formulation, process development, and regulatory support.

Responsibilities

• Lead drug product programs as DPTL and coach a scientific team.
• Plan, design, execute and document studies for commercialization.
• Oversee tech transfers, process changes and non-conformance investigations.
• Collaborate with global teams to drive process improvement and lifecycle management.
• Author regulatory submissions and develop robust responses to questions.

Skills

People management

Cross-functional collaboration

Analytical thinking

Statistical analysis

Education

PhD in Biotechnology/Pharmaceutical Sciences/Pharmaceutical Chemistry/Chemical Engineering/Biomedical Engineering

8+ years pharma development and management experience

8+ years formulation and process development experience

Experience with drug product commercialization and end-to-end development

Experience with process transfers and regulatory responses

Aseptic processing and cGMP knowledge

New product development and equipment design experience

Job description

Career Category Scientific Job Description

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.

Associate 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 an Associate Director to lead commercial drug product programs as DPTL and lead a scientific team that supports advancing the commercial drug product programs in our portfolio. Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of parenteral and/or oral solid dosage presentations. Lead a team of scientists focused on late‑stage drug product process development and tech transfer and coach staff with emphasis on people-centered leadership. Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non‑conformance investigations and process changes/improvements. Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering. Participate and lead global cross‑functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships. Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions. Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs. Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis. Ability to travel domestically and internationally up to 10% of the time.

What we expect of you

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

Basic Qualifications

• Doctorate degree and 3 years of experience in engineering or science
• Masters degree and 7 years of experience in engineering or science
• Bachelors degree and 9 years of experience in engineering or science
• Associate’s degree and 12 years of experience in engineering or science
• High school diploma / GED and 14 years of experience in engineering or science

And 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.

Preferred Qualifications

• PhD from an accredited college or university in one of the following areas Biotechnology, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area
• 8+ years of pharmaceutical development and management experience
• 8+ 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 with hands‑on experience with end‑to‑end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
• Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites
• Understanding of physical/chemical stability of proteins and how process‑related stress impacts product quality, specifically, the impact of freezing and drying to short‑and‑long‑term stability
• Strong knowledge about developing processes with single‑use manufacturing equipment
• Aseptic processing experience and familiarity with cGMPs, ICH guidelines
• Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Strong problem solving and effective cross‑functional communication skills
• Proven ability to learn and act on dynamic information at a rapid pace
• 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

What you can expect of us

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 sales-based incentive plan Stock‑based long‑term incentives Award‑winning time‑off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Salary Range

Salary Range 164,021.95USD -221,912.05 USD

We are 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.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen 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 biologics manufacturing 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen