Process Development Sr. Scientist – New Product Introduction | Amgen
Job ID: R-100484
Location: Juncos, PR, US 00777
Posted Date: 7/9/2020
Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Sr. Scientist – New Product Introduction 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 role of the Process Development Sr. Scientist – New Product Introduction is to oversees, manages and coordinates all operational aspects of ongoing department level projects driving impactful results on multiple organizations. Serves as liaison between project team and drug product organization, including supporting the implementation of technical transfer, new product introductions, business cases and Drug Product Process Development portfolio. This role is crucial for Amgen’s success and will be a key contributor in PD-Drug Product organization. Supporting Drug Product manufacturing facilities of oral dosage form and parenteral products including all process stages from formulation, filling, inspection, assembly, and packaging.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Responsible for integrating Process Development (“PD) activities by developing and maintaining project schedules for Amgen pipeline projects.
- Develop and aligns plans and schedules for PD activities with business priorities.
- Captures associated project risks, develops mitigation plans and communicates project status clearly to impacted stakeholders.
- Assists with driving decision making for the project and ensures that action items are captured and tracked to completion.
- Partners with PD technical leads to identify key deliverables and activities to be completed, identifies dependencies, and optimizes the sequence of project activities.
- Ensures cross-functional alignment through the integration of interdependent activities and through the communication of plans and timelines, with specific emphasis on critical path activities.
- Assists PD technical leads with tracking the implementation of required deliverables and assists with navigating project teams through corporate governance.
- Collects, digests and assembles information to enable business analysis and influence decision-making.
- Demonstrate soft skills, technical knowledge, and leadership attributes to influence positive project outcomes.
- Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
- Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
- Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
- Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
- Manage and track project budget(s).
- Negotiate and reconcile the use of resources for the projects.
- Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
- Develop and implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
- Actively participate in directing the evolution and defining the role of the project
- Ensure the project goals and objects are well understood by the various functional areas.
- Liaison with Management, Department Heads, Leaders, sub team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
- Maintain the master project plan and schedule for assigned projects.
- Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
- Provide senior management and department heads with project management support on an as needed basis as well as for special projects.
- May manage and direct the activities of project support staff
- Identify or leads focus area projects within the overall function of project management or related projects.
- Generate periodic updates and prepare formal presentations for required forums.
- Generate individual and more sophisticated reports utilizing various resources.
- Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines to area of responsibility.
- Ensure project work complies with practices, policies and standard operating procedures.
- Participate in required meetings, activities, projects and interdepartmental activities.
- Anticipate resource needs and communicate to management sponsors.
- Support projects that utilize internal and external personnel, contract firms, and partners
- Assist PD in driving decision making using DAI principles (D- Decision maker, A- Advice Giver, I- Informed) by producing risk analyses and scenario planning
- Ensure participation in functional and cross-functional management reviews
- Establish and manage collaboration and team SharePoint sites.
- Manage and prioritize support of multiple project teams at one time
- Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
- 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)
- 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.
- Monitor field of expertise, including literature and technology development, and communicates observations.
- Apply knowledge of scientific/engineering principles and practices outside of area of expertise to broad variety of assignments in related fields
Basic education & experience
Doctorate degree and 2 years of experience
Master’s degree and 6 years of related experience in a GMP regulated industry.
Bachelor’s degree and 8 years of related experience in a GMP regulated industry.
- Knowledge and experience with Ariba Sourcing and Contracting Modules.
- Experience with SAP, Trackwise and Project management tools preferred.
- Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
- Skills in working under time pressure.
- Practical project management software and spreadsheet skills, proficient computer operation skills.
- Effective interactions in a team or matrixes environment
- Good organizational skills, focus on detail, and accurate analytical skills.
- Must be a great teammate, self-starter, strategic problem solver, persistent, tactful, and persuasive.
- Fluent business English and Spanish, written and oral
- Effective verbal and written communication skills (writing and presentations).
- Must be capable of growth and increased responsibility.
- Highly proficient with MS Office, including Excel, Word and PowerPoint
- Educational background Chemistry, Biology and/or Industrial or Chemical Engineering.
- 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.
To apply for this job please visit bioinformaticsindia.com.