Amgen Process Development Scientist - Material (Polymers/Molding) in Juncos, Puerto Rico
Are you looking for a significant new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Scientist – Material (Polymers/ Molding) 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 (Polymers/Molding) will be responsible to perform forensic evaluations of components, final drug product in devices, syringes or vials to support root cause analysis from product complaints, and manufacturing events. The scientist will use advance laboratory techniques and knowledge in material science of polymers to support investigations in our Parenteral Drug Product manufacturing facilities. The candidate will develop a deep understanding of the operations and become a subject matter expert with the following equipment and techniques: CT scans, X-rays, microscopic evaluations, Instron force testing among others. The role will support technical teams to identify sources of deviations for polymer breakage, molding defects, particles and other process generated defects. The candidate will craft experiments to identify root causes and provide process specialists recommendations and findings to close investigations. 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:
Identify raw material and container components (polymer/plastics) defects and provide solutions related to possible technical problems of moderate scope and complexity.
Demonstrates knowledge regarding polymer formulation process and raw material and primary container components defects and classifications.
Understand the nature, structure and physical properties of polymers components and their responses to stress mechanisms
Perform experiments, records, organize data and analyze results under minimal direction.
Understands and interprets raw materials and primary components specifications and methods.
Test individual parts and products to ensure that manufacturer and governmental quality and safety standards are met
Follow established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables
Assist commercial manufacturing with troubleshooting activities and investigation of deviations, CAPAs, business cases development and regulatory agencies inspections, including local or corporate audits
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.
Write and/or review standard operating procedures, protocols, raw material specifications, and reports.
Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations
Apply sophisticated technical principles, theories, and concepts in the development of new process solutions and novel concepts to address specific issues.
Assume lead role in department-wide support efforts such as safety, operational excellence and other committees.
Complete sophisticated or novel assignments requiring development of new and/or improved scientific/engineering techniques and procedures.
Monitor and maintain inventory of supplies and sample inventory.
Available to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
Meet specific project goals and timelines.
Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to complete investigations.
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.
Adheres to company policies and procedures to ensure a continuous state of compliance
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Share knowledge to develop the teammates in expertise subject area.
Independently author and review protocols, experiments, scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
Generates robust and reliable data in compliance with the respective protocol, methods or SOPs
Monitor field of expertise, including literature and technology development, and communicates observations.
Apply knowledge of scientific/engineering principles and practices outside of area of field expertise to broad variety of assignments in related fields
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 forensic evaluations of materials
Knowledge in Raw Materials and Primary Packaging Components (plastic tubing, aseptic connectors, vials, syringes, cartridges, etc.)
Primary Packaging Evaluations and Polymers Forensic Analysis
Advanced scientific analysis and troubleshooting skills
Able to work in manufacturing and laboratory environment
Experience with equipment commissioning and qualification, validation and documentation processes in a highly regulated environment
Demonstrated external scientific track record which may include peer reviewed publications, scientific conference participation or participation in industry working groups or panels
Advanced 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.
Educational Background: Material Sciences & Engineering, Polymer Chemistry, Plastics Engineering, Chemical Engineering, Chemistry, Physics or other t field, within polymers, background in 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 that relies on collaboration for effective decision-making
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.