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Full-time, Contract
bachelor degree
Posted 33d ago
~40 hrs/week
Responsibilities
Manage the Separation Sciences and in-process team while ensuring compliance with cGMP and GDP regulations. Focus on continuous improvement, lean culture, and Right First Time (RFT) implementation for commercial product testing and release.
Requirements
Requires a Bachelor's degree in a science-related field and at least 6 years of biopharmaceutical QC or GMP laboratory experience. Desirable experience includes 2-3 years of QC laboratory management and a proven track record of leading teams.
This role will be responsible for managing the Separation Sciences and in-process team while owning, facilitating, and undertaking activities pertaining to QCSS within QC. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for QCSS duties and testing, including release/stability/in process of commercial product. The role also represents the QC unit by liaising with internal and external stake holders
The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.
Key Responsibilities
Supervision/Management of QC Separation Sciences including In-process team
Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored and distributed according to current cGMP, GDP and other applicable regulations
Provides coaching, feedback and mentoring to ensure team development.
Builds relationships and collaborates cross functionally with ADL and Network colleagues to share lessons learned and improvements
Ensures deviations from established procedures are investigated and documented per procedure
Represents QC during Audits and Inspections regarding preparation and participation
Represents QC at site and network level .
Supports Continuous Improvement and Error management initiatives, programs and projects.
Works with minimal supervision but knows when to escalate or look for support
Primary knowledge, skills, competencies and relevant experience
Knowledge:
Broad technical knowledge within Separation Sciences area and expanding knowledge of related disciplinary areas, specific knowledge HPLC, Capillary Electrophoresis and SDS/IEF Gels is an advantage.
Recognizes and understands the cross-dependencies of the technologies and understands the impacts on the organization
Enhances own knowledge through understanding business trends and objectives
Knowledge of industry and business principles
Understands the core business process and purpose of the functional area in Amgen's commercialization process
Developing own project management techniques
Problem Solving:
Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information. Creates new procedures and processes to drive desired results Handles diverse scope of issues that require evaluation of a variety of factors including current business trends
Autonomy:
Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role. Experience leading cross-functional teams is desirable. Work is guided by operational and project objectives.
Manages multiple assignments and processes.
Independently determines approach to project
May be responsible for specific programs and/or. projects Independently develops solutions that are thorough, practical, and consistent with functional objectives
Contribution:
Contributes to work group/team by ensuring quality of tasks/services provided by self and others with a strong focus on RFT and Lean Provides training and guidance to others Extends capabilities by working closely with senior staff/experts within and outside the internal organization
Skills:
Lead with initiatives to identify and drive improvements Communication skills (verbal and written) at all levels.
Escalate issues professionally and in a timely basis and know when to escalate
Decision Making skills – will be required to make decisions independently.
Teamwork, Coaching and motivating others, Negotiation and Influence skills, Planning and Organisation skills, Investigation skills.
Demonstrated ability to interact with regulatory agencies Experience working with interdepartmental and cross functional teams and influencing decisions.
Relevant experience:
Bachelor’s degree in a Science related field is required. 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with of 2 – 3 years of specific QC laboratory management experience is desirable. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating. Proven experience of leading teams
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical