Job Information
Amgen Process Development Senior Scientist - Formulation in Juncos, Puerto Rico
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Process Development Senior Scientist - Formulation
Live
What you will do
Let’s do this. Let’s change the world! In this vital role, you will develop, characterize, and validate processes in support of our Parental Drug Product manufacturing facility. The areas of support include buffer preparations, compounding, filtration, product holds, and filling liquid vial and syringe presentations of biologic products. The candidate will develop a deep understanding of the operations and become a subject matter expert with the following equipment: single-use tanks, stainless steel tanks, transfer panels, mixers, filtration, and filter integrity. The role will support activities including new product introduction, commercial support, improvement of existing processes, and acquisition of new technologies. The candidate will execute mixing studies, filter Vmax studies and filtration rates, and mass balance among others. The position requires to have good documentation skills to write reports that can be used in regulatory audits.
Specific responsibilities include but are not limited to:
Technical
Develop, design, implement and perform specific scientific experiments with protein based products to optimized or develop new formulation processes and to support investigations.
Evaluate and interprets experimental results and provide recommendations based on scientific data using strong statistical methodologies.
Provides input to new processes to generate robust and reliable data.
Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations
Technical lead in the transfer of new products/processes to the manufacturing area including the development of characterization/validation strategies, executions, and reports aligned with Amgen policies and regulations.
Manage process improvement projects to improve productivity and efficiency.
Provide on-the-floor support to commercial operations on a day-to-day basis providing assessments of product impact and document revisions and transfer the knowledge to operators in manufacturing.
Conceive plans and conduct scientific research/investigation in areas of considerable scope and complexity.
Apply advanced technical principles, theories, and concepts in the development of new process solutions and novel concepts to address specific issues.
Establish, lead, and/or participate in technical forums for sharing standard methodologies, improvements, and application of formulation process expertise
May support or lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments in developing requirements and recommendations for large and/or highly complex system/facility or process modifications.
General
Prompt and regular attendance at the workplace. Although the main working hours are regular administrative hours, the role may support a non-standard shift structure. This will include performing on-the-floor activities in the first, second, third, 12-hour, and/or weekend shifts structure as per business needs.
Develop project plans and strategies for implementation by working with project managers and SMEs.
Communicates and/or presents scientific/ technical information within the area of expertise across projects within a function/department, and occasionally to the external scientific community (i.e. regulatory agencies, review boards, conferences)
Supervise, coordinate, and review the work of a small team on a project basis. May develop supervisory and mentoring skills, having contract workers direct reports.
Contributes to and may author scientific/technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients! The Process Development Sr. Scientist professional we seek is an Individual Contributor Leader with these qualifications.
Basic Qualifications:
Doctorate degree
Or
Master’s degree and 3 years of Process Development and/or Technical Services experience
Or
Bachelor’s degree and 5 years of Process Development and/or Technical Services experience
Preferred Qualifications:
Technical Skills
Educational background in Life Sciences and/or Engineering. (Biochemistry, Chemical Engineering, or Life Sciences).
Experienced in parental aseptic formulation/filling processes.
GLPs and GMP experience with Working knowledge of pharmaceutical/biotech processes.
Experience with mixing studies, shear rate calculations, Vmax determination for filter sizing, filtration rates, protein science, mass balance, and scale-up.
Familiarity with documentation in a highly regulated environment with advanced laboratory work skills.
Able to develop solutions to routine technical problems of limited scope.
Experience in technology transfer and process validation life cycle.
Experience in regulatory filings and RTQs authoring with a good understanding of process monitoring and statistical tools.
General Skills
Excellent communication skills: oral and written. Interacts effectively with a variety of communication and working styles.
Fully bilingual in Spanish and English
Demonstrated strong problem-solving and conflict resolution
Demonstrated leadership skills, initiative, and self-motivation.
Excellent time and project management skills to deliver projects on time and budget.
Standout colleague with strong negotiation skills to work with multidisciplinary teams
High quality and compliance mentality to work in a highly regulated GMP industry.
Computer literacy (Windows environment: Word, Excel, PowerPoint, Minitab)
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance
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 and an annual site shutdown
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.