Process Development Senior Principal Scientist

Amgen Foundation, Inc.; Thousand Oaks (CA); Hybrid; USD 158,000 - 213,000; Full time

Job summary

Amgen Inc. is seeking a Process Development Senior Principal Scientist to lead commercial drug product programs, driving formulation design, aseptic processing, and lifecycle management of parenteral products.

The role partners with Drug Product Technologies to advance late-stage development and tech transfer for global supply. You will manage a scientific team, apply first principles in process engineering, and support regulatory interactions for product changes while supporting continuous

Qualifications

• Pharmaceutics/biotech background with drug product development experience.
• Experience with liquid, lyophilized and solid dosage forms.
• Proven track record in tech transfer and process characterization.

Responsibilities

• Lead drug product development and tech transfer activities.
• Guide a scientific team on lifecycle management of commercial products.
• Support regulatory submissions and change controls.
• Collaborate with cross-functional teams across global sites.

Skills

Process development leadership

Aseptic filling knowledge

cGMP compliance

Regulatory submissions support

Cross-functional collaboration

Education

Doctorate degree in Pharmaceutics/Engineering/Related

PharmD or MD consideration

Master’s degree with relevant experience

Bachelor’s degree with substantial experience

Job description

Process Development Senior Principal Scientist### Process Development Senior Principal ScientistApply: Flex Commuter / Hybrid: US - California - Thousand Oaks: US - Massachusetts - Cambridge: Full time: Posted Today: R-261067## **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. **Senior Principal Scientist, 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 Sr. Principal Scientist 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 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 PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of engineering or science experience OR* Master’s degree and 6 years of engineering or science experience OR* Bachelor’s degree and 8 years of engineering or science experience **Preferred Qualifications:*** Advanced degree in Pharmaceutics, Biotechnology, Engineering or related discipline and industry experience in pharmaceuticals/biotechnology* 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**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. Apply now and make a lasting impact with the Amgen team.**careers.amgen.com**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. **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. SponsorshipSponsorship 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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation..**Salary Range**157,737.05USD -213,408.95 USD