Amgen Process Development Scientist in Juncos, Puerto Rico
Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Scientist – Material to join AML’s Process Development Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.
The Process Development Scientist - Material will be responsible for the end-to end implementation of new Single Use Systems for formulation and drug product filling. The scientist will design, characterize and validate processes using single use technology in support of our Parenteral Drug Product manufacturing facility. The areas of support include buffer preparations, compounding, filtration, and aseptic filling of 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, filtration systems, aseptic filling assemblies for fillers, transfer panels, mixers, and filter integrity. The role will support activities including new product introduction, commercial support, improvement of existing processes and acquisition on new technologies. The candidate will design single use solutions evaluating leachable, extractables profiles, particle requirements and systems integrity for aseptic filling working closely with suppliers to develop solutions meeting the requirements. 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:
Design layout, material of construction and component selection for single use systems to be used in formulation and aseptic filling applications.
Test prototypes and support all commissioning and qualification activities for GMP implementation.
Work with multidisciplinary teams including quality, system owners, process owners, automation, suppliers and general engineering personnel to integrate new technology to operations.
Build and maintain effective cross-functional collaborations with peers from across the Amgen network, as well as, our vendors to ensure uninterrupted supply of materials for manufacturing of Drug product.
Provide technical evaluations for supplier change notifications and change controls.
Assist commercial manufacturing with troubleshooting activities and investigations of deviations, corrective actions, business cases development and regulatory agencies inspections, including local or corporate audits.
Write and/or review standard operating procedures, protocols, material specifications, and reports.
Assist other Amgen groups implementing innovative solutions
Develop, design, implement and execute specific scientific experiments with protein-based products using single use technology.
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/process to the manufacturing area including the development of characterization and validation strategies, implementations and reports align with Amgen policies and regulations.
Lead process improvement projects to improve productivity and efficiency.
Transfer knowledge to operators in manufacturing
Provide on the floor support to commercial operations on a day to day basis providing assessments of product impact and document revisions
Apply sophisticated technical principles, theories, and concepts in the development of new process solutions and novel concepts to address specific issues.
Establish, leads and/or participate in technical forums for sharing the best methodologies 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 sophisticated system, facility or process modifications.
Available to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
Meet specific project team goals and timelines.
Develop project plans and strategies for implementation working with project managers and SMEs.
Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects.
Communicates and/or presents scientific/ technical information within 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 work of a small team on a project basis.
May develop supervisory and mentoring skills.
Contributes to and may author scientific/technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)
May represent the department on project teams under supervision of a senior scientific staff member.
May initiate productive collaborations within and outside of the department or company.
Basic education & experience
Master’s degree and 3 years’ experience in GMP regulated industry
Bachelor’s degree and 5 years’ experience in GMP regulated industry
Experience in the pharmaceutical or other related industry involving the implementation or application of single-use technologies for upstream and downstream processing
Experience with mixing studies, shear rate calculations, Vmax determination for filter sizing, filtration rates, protein science, mass balance and fluid dynamics
Knowledge or direct experience with state-of-the art sophisticated materials and data acquisition
Demonstrated external scientific track record which may include peer reviewed publications, scientific conference participation or participation in industry working groups or panels
Sophisticated scientific writing, problem solving skills and abilities with technology commercialization
Familiarity with documentation in a highly regulated environment.
Ability to interpret and apply GLP's and GMPs.
Experience in technology transfer and process validation lifecycle
Educational Background in Science and/or Engineering (Materials Science & Engineering, Polymer Chemistry, Plastics Engineering, Chemical Engineering, Chemistry with focus on polymers and molding or related Life Sciences)
Experience Process Development and/or Technical Services including working with plastics, rubbers, and elastomers among others
Excellent communication skills: oral and written. Interacts effectively with 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.
Great teammate with strong negotiation skills to work with multidisciplinary teams
High quality and compliance mind set to work in a highly regulated GMP industry.
Computer literacy (Windows environment: Word, Excel, Power Point, Minitab)
Our broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program – and on-site child care and fitness facilities – you will find us passionate about your well-being too.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses its 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.
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.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.