Associate Director Validation Jobs in Boston, MA

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 OR

Masters degree and 7 years of experience in engineering or science OR

Bachelors degree and 9 years of experience in engineering or science OR

Associate's degree and 12 years of experience in engineering or science OR
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. Your managerial experience may run concurrently with the required technical experience referenced above

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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll 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 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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship for this role is not guaranteed.

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.

Salary Range