Senior Manager Manufacturing Downstream Bulk Drug Substance
Job Location:
Holly Springs, MS - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
HOW MIGHT YOU DEFY IMAGINATION
Youveworked 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies reaching over10 million patientsworldwide. Come do your bestworkalongside other innovative driven professionals in this meaningful role.
Be part of Amgens newest and most advanced drug substance manufacturing plant. The AmgenFleXBatch facility combines the latest insingleusetechnologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it also integrates sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.
Senior Manager: Manufacturing- DownstreamBulk Drug Substance
Live
What youwill do
Letsdo this.Letschange the world. As Senior Manager of Manufacturing you will provide leadership and guidance to the team responsible for 24/7 manufacturing operations in downstream purification.
In this vital role as a member of the Manufacturing Leadership Team the Senior Manager of Manufacturing will collaborate cross-functionally to enable the commissioning qualification start-up and GMP operation of a new drug substance manufacturing facility. This roleis responsible forcoaching and developing Downstream Front-Line Managers who oversee staff supporting direct drug substance production.
The Senior Manager will be accountable for the organizational design of the manufacturing team including workforce planning hiring onboarding training qualification and development of staff to support safe reliable and compliant operations. The role will ensure that personnel are appropriately trained and qualifiedin accordance withestablished training programs procedures and operational readiness requirements.
The position will provide leadership and manufacturing oversight for Commissioning and Qualification activities associated with downstream process systems equipment utilities and supporting infrastructure. Responsibilities will include partnering with Engineering Quality Automation Validation Process Development and project teams to review system designs commissioning and qualification protocols acceptance criteria turnover packages and supporting documentation to confirm that systems are safe compliant maintainable and operationally ready.
The Senior Manager will ensureappropriate Manufacturingparticipation in design reviews system walkdowns factory and site acceptance testing commissioning execution equipment qualification process demonstrations water runs engineering runs and performance qualification activities. The role will also support the identification documentation escalation and resolution of equipment process automation and facility issuesidentifiedduring C&Q and start-up. The position will also provide leadership and oversight for downstream chromatography column packing activities to ensure readiness for reliable GMP operations.
Additionally the Senior Manager will lead operational readiness activitiesfor successful facility start-up and transition to routine GMP manufacturing. This includes development and execution of readiness plans establishment of operating procedures and standard work completion of training and qualification activities confirmation of materials and equipment availability implementation of shift structures and verification that manufacturing systems and support processes are prepared for operation.
The position willestablishand monitor readiness metrics risks dependencies and action plans ensuring that gaps areidentifiedearly assigned to accountable owners and resolved in alignment with project and manufacturing milestones. The Senior Manager will also ensure effective handover of qualified systems from the project organization to Manufacturing andestablishsustainable processes for equipment ownership system performance monitoring troubleshooting preventive maintenance coordination and continuous improvement.
Following facility start-up the Senior Manager will be accountable for sustained manufacturing performance including safety quality compliance schedule adherence operational reliability workforce capability and continuous improvement across downstream purification operations.
Responsibilities:
Develop andretaina diverse and high performing team in alignment with operational readiness schedules to ensure successful startup and commercial GMP operations
Mature the sites safety and quality culture of the department and champion continued improvement
Collaborate as one team of all manufacturing support groups (Quality Process Development Engineering Supply Chain and network partners)
Provide support to troubleshootidentify and resolve issues as needed and manage call coverage for 24/7 operation
Provide technical leadership for the investigation of deviations and the development of corrective actions
Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy and deliver continuous improvement
Provide leadership and oversight for downstream chromatography column packing activities including planning execution qualification troubleshooting documentation and readiness to support reliable GMP manufacturing operations.
Lead and support regulatory inspections for areas of responsibilities including evaluating complex compliance issues and developing playbooks for the inspections
Deliver against organizational financial commitments while championing a lean philosophy
Provide Manufacturing leadership and support for Commissioning and Qualification activities including design reviews system walkdowns protocol execution issue resolution and equipment turnover
Lead operational readiness activities for downstream manufacturing including procedures training staffing materials system ownership and readiness assessments to support successful facility start-up and transition to GMP operations.
Win
What we expectofyou
We are all different yet we all use our unique contributions to serve patients. The experienced professional weseekis a collaborative partner with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Manufacturing & Operations experience Or
Masters degree and 6 years of Manufacturing & Operations experience Or
Bachelors degree and 8 years of Manufacturing & Operations experience Or
Associates degree and 10 years of Manufacturing & Operations experience Or
High School diploma/GED and 12 years of Manufacturing & Operations experience
AND2 years of managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources
Preferred Qualifications
Demonstrated managerial experience in a GMP manufacturingdrug substanceplant
Demonstrated experience in applying Operational Excellence and Lean Manufacturing
Cross-functional work experience in either Process Development Quality or Engineering
Excellent communication skills drive sense of urgency energyleveland problem-solving abilities
Demonstrated ability to forge andmaintainstrong relationships with other functional areas
Ability to effectively develop and coach staff and positively advance the culture of an organization
Thrive
What you can expectofus
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.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprisinghealth finance and wealth work/life balance and career benefits
Apply now
for a career that defies imagination
In our quest to serve patientsabove all else Amgen is the first to imagine and the last to doubt. Join us.
#AmgenNorthCarolina
Salary Range
136227.80USD -184308.20USDRequired Experience:
Senior Manager
About Company
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 ... View more
