Director, Manufacturing Execution Job at Amgen (Holly Springs)

Senior Manager / Associate Director, Manufacturing

Beam is looking for a highly energetic Sr Manager/Associate Director, Manufactur...

Location

United States , Durham, NC

Salary:

155000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferably with a science or engineering focus and a minimum of 10 years of Manufacturing and Operations experience
At least 2 years experience leading and developing people in a GMP setting
Experience working cross-functionally building and maintaining strong relationships
Autologous cell therapy experience strongly preferred

Job Responsibility

Cultivate Beam’s culture and our values-driven organization focused on people
Execute against the mission, vision, and strategy for Beam internal cGMP Manufacturing
Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations
Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget
Champion development of a learning culture that embraces innovation and continuous improvement
Prepare and maintain departmental budget and workforce model in partnership with the Director of Manufacturing
Support establishment of long range and business continuity plans
Manage and support up to but not limited to multiple areas of GMP production as needed
Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions
Build collaborative and empowered teams that put patients first

Fulltime

Senior Director, Manufacturing Engineering

The visionary and results-driven Senior Director of Manufacturing Engineering wi...

Location

United States , Mobile

Salary:

Not provided

Airbus

Expiration Date

Until further notice

Requirements

Bachelor/ Master Degrees Engineering, Mechanical Engineering, or Electrical Engineering or an equivalent combination of education and experience
10+ years in Aerospace Manufacturing Engineering or equivalent Engineering environment
5+ years in senior leadership
Strong leadership skills with the ability to maximize resources and deliver goals
Has a structured way of working and the ability to deal with a volume of complex information
Have the ability to establish and maintain a good relationship with all internal customers
Have the ability to work in an international team
Must possess excellent communication and presentation skills, both verbal and written - including the ability to discuss with Executive Levels in a major company
Must be able to present clear and concise briefings and reports to customers and executives
20% Domestic and International Travel

Job Responsibility

Develop and execute a multi-year manufacturing engineering roadmap that aligns with corporate growth objectives and technological advancements (Industry 4.0)
Develop an Industrial Improvement Roadmap which adapts the Industrial setup to remain compliant, competitive and up to date based on the current Lean methodologies
Develop and deploy a Line Side support for Operations Teams which provides immediate support to resolve complex Manufacturing Engineering points
Lead the execution of A320 build Head of Versions and Variants from Design to Manufacturing and Assembly, ensuring new product introductions (HoV) transition seamlessly into the Manufacturing and Operational areas
Ensure at all times that the Manufacturing Dossiers (means and methods) are matching the Design Drawing sets and that there are no deltas (gaps) to the defined design solution for a given product or buid
Implement and sustain Lean Manufacturing, Six Sigma, and Total Quality Management (TQM) principles to reduce waste, cycle times, and Cost of Non-Quality
Implement and Sustain a system of Quality Management standards which ensure that constant product improvements are realized through Advanced Product Quality Process (PFMEA, PPV, FAI)
Drive the implementation and maturity of the Airbus Operating System, emphasizing the standardization of line balancing and operating instructions
Oversee the deployment of the CAPEX budget for the Industrial System, prioritizing investments in Quality, manufacturing improvements, and efficiency
Manage the definition of the Industrial system and its associated roadmap for short/medium/long term improvements and adaptations based on the defined targets (Quality, Lead Time, Competitiveness)

What we offer

Competitive base salary, incentive compensation which may include profit sharing schemes, retirement savings plan and the ability to participate in an Employee Stock Ownership Plan (“ESOP”)
Paid time off including personal time, holidays and a generous paid parental leave program
Comprehensive insurance coverage including medical (traditional and high-deductible health plans), prescription, dental, vision, life, disability, Employee Assistance Plan (“EAP”) and other supplemental benefit coverances
Upskilling and development opportunities through our global Leadership University, including unlimited access to 10,000+ e-learning courses focusing on ways to develop your employability, certifications, career path as well as the opportunity to participate in accelerated development programmes and both national and international mobility
relocation assistance for qualified positions

Fulltime

Senior Director, Manufacturing Operations North America

Are you excited by the opportunity to shape, scale, and lead a multi-site manufa...

Location

United States , Calabasas, CA

Salary:

221000.00 - 331000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

Significant multi-site leadership experience in a manufacturing or operations environment
Proven success building and leading high-performing teams and leaders
Excellent communication, stakeholder management, and influencing skills, with the ability to thrive in a global, cross-functional organisation
Demonstrated success improving operational efficiency, reliability, quality, and cost
Strong knowledge of regulatory standards, quality systems, and Lean or continuous improvement methodologies
Experience leading site start-ups, expansions, or major transformation programs

Job Responsibility

Lead the North America Manufacturing Network
Provide strategic and operational leadership across the LA, Atlanta, and future North America sites
Partner with cross-functional teams and external bodies, including government agencies, to enhance capability, capacity, and compliance
Shape the long-term manufacturing strategy and play a central role in selecting and standing up our next North America manufacturing site
Build High-Performing, Inclusive Teams
Lead and develop leaders across multiple states and sites - building a culture that is safe, innovative, inclusive, and empowering
Foster strong communication, collaboration, and accountability across the network
Attract, grow, and retain exceptional talent to support both current operations and future expansion
Drive Operational Excellence & Transformation
Champion Lean, continuous improvement, and advanced/digital manufacturing initiatives across all sites

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Paid Time Off (PTO)
paid holidays
floating days
primary caregiver or secondary caregiver leave

Fulltime

Senior Director, Manufacturing, Science & Technology

As a Senior Director, Manufacturing, Science & Technology, you will lead a high-...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

PhD in Chemistry, Biochemical Engineering, or a related scientific discipline
Extensive experience in pharmaceutical or biotechnology manufacturing, with deep expertise in process development for both small and large molecules
Proven knowledge in sterile processing, fill-finish operations, and packaging
Strong understanding of CMC requirements and regulatory dossier submissions (EMA, FDA)
Inspirational leadership with a hands-on approach to managing technical operations, complex projects, and cross-functional teams
Exceptional analytical, scientific, and communication skills, with the ability to convey complex concepts to diverse stakeholders
Fluency in English is essential
Willingness to travel internationally as required

Job Responsibility

Provide strategic direction and technical oversight for all external manufacturing activities
Lead and oversee the execution of technology transfers, validation programs, and lifecycle management for both new and existing products
Establish and monitor performance metrics, proactively manage risks, and make data-driven decisions aligned with business objectives
Ensure robust technical evaluations for material changes, process scale adjustments, and cost-efficiency initiatives
Contribute to vendor qualification, audit processes, and long-term capacity and supply planning
Ensure full compliance with cGMP regulations and internal quality standards across all operations
Lead and manage a team of pharmaceutical technical and scientific experts
Serve as the primary technical liaison with CMOs, ensuring alignment with strategic goals and regulatory expectations

What we offer

A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
We support you as you grow and learn, and we love to celebrate success and recognize performance
We provide opportunities for driven and talented professionals who want to be part of our exciting journey

Associate Director, Manufacturing Science and Technology

We are seeking a dynamic and experienced MSAT Associate Director to support late...

Location

United States

Salary:

175000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience
7+ years of biologics development and manufacturing experience
Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support
Experience with process and economic modeling of DS manufacturing processes
Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain
Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Ability to multi-task and keep pace with a fast-moving organization
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Job Responsibility

Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment
Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners
Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations
Analyze process and manufacturing data to understand and optimize process performance
Develop process characterization and PPQ strategies and documentation
Support regulatory activities including submissions and site inspections from preparation through execution
Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements
Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Director, External Manufacturing Operations (Backend Engineering)

WHAT YOU DO AT AMD CHANGES EVERYTHING At AMD, our mission is to build great prod...

Location

Taiwan , Hsinchu

Salary:

Not provided

AMD

Expiration Date

Until further notice

Requirements

Minimum 20 years+ experience in IC Substrate/PCB Engineering & Operations or with Fabless companies (Managing substrate suppliers).
Experience in Co-working/managing horizontally across multiple internal functional organizations.
Technical expertise in FC-BGA, LGA, Adv PKG Substrates & PCB Manufacturing /Development and related Interactions.
Experience in substrate/PCB development, from NPI to HVM, is a plus.
Team player with a commitment to meeting deadlines/Lead & Drive for solutions and an aptitude to thrive in a fast-paced multi-tasking environment.
Creative, Self-Driven, highly motivated individual with demonstrated ability to independently manage complex engineering tasks.
Strong interpersonal communication, analytical, project management, task & time management and excellent executive presentation & communication skills.
Strong Statistical knowledge Familiar with failure analysis tool, package reliability knowledge and Industry standards is essential
People management skills.
Good English speaking, Executive communication, and Presentation skills.

Job Responsibility

Plan, Drive and Manage Substrate & PCB supplier and AMD internal stakeholders from NPI bring up/Qualification/ Ramp Up readiness to Production release and sustaining.
Supplier Qualification - NPI to LVM to HVM, with First pass and Issue free production for 6 months to ensure Repeatability and Reproducibility.
Substrate & PCB supplier's new production site bring up & qualification.
Drive HVM yield attainment, sustaining-issue resolution and issue prevention and improvements through Data Analytics. System Integration with Data Analytics to have real time update and control over supplier overall performance.
Lead knowledge-sharing initiatives (Best Known Methods, lessons learned) and drive Continuous Improvement Projects (CIPs).
Monitor & Drive supplier performance using scorecards and lead quarterly technical reviews to ensure improvements.
Lead projects to drive cross supplier performance improvement/quality enhancement
Drive for supplier engagement on continuous improvement. Drive supplier to enhance process, equipment & material capability for future generation/technology products and capabilities ahead of roadmap needs.
Plan and execute change management.
Responsibilities will include defining and managing Key Program deliverables/schedules/budget/Analyze program risk and opportunities & monitor progress to drive to ensure goals are met.

Fulltime

Senior Director, AIN Manufacturing Lead

The Senior Director, AIN Manufacturing Lead is a key member of the Amgen India C...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

22 to 26 years of experience leading global or regional manufacturing organizations within a regulated industry
Demonstrated success building, scaling, and transitioning capability centers, shared services, or captive organizations from stand-up to steady-state operations
Strong understanding of GxP environments and regulatory inspection processes
Experience leading large-scale transformation, operating model design, and operational excellence initiatives with measurable outcomes
Ability to influence and align senior stakeholders across geographies and functions
Track record of developing high-performing teams and leadership pipelines
Experience translating Manufacturing business needs into adopted digital, analytics, and automation solutions with measurable business impact
Experience leading large, matrixed global teams across time zones and cultures, including establishing governance, decision rights, and operating norms during scale-up
Experience owning performance through KPIs or service measures such as quality, compliance, cost, productivity, cycle time, and stakeholder satisfaction
Experience partnering across Manufacturing, Quality, Supply Chain, Engineering, Process Development, EHS, and Digital/Technology in a regulated environment

Job Responsibility

Define and lead the Manufacturing vision, multi-year strategy, and phased capability roadmap for AIN, aligned with global Manufacturing and Operations priorities
Translate enterprise objectives and the Technology and Workforce Strategy (TWFS) into durable operating models, governance, workforce plans, and scalable delivery capabilities
Ensure AIN-based Manufacturing capabilities and services are fully integrated into global Manufacturing standards, processes, decision forums, and ways of working
Partner with Manufacturing, Digital/Technology, and adjacent functions to translate business needs into implemented digital, analytics, and automation solutions with measurable adoption and business impact
Own end-to-end delivery and performance of AIN Manufacturing capabilities and services from stand-up through steady-state operations
Ensure delivery of high-quality, efficient, and compliant Manufacturing capabilities and services aligned with global standards and stakeholder expectations
Establish, negotiate, and deliver against SLAs and defined success measures with internal stakeholders and global sites
review performance through clear operating rhythms and escalation pathways
Oversee resource planning, demand and capacity management, budget, and operational performance to meet service, financial, and business targets
Deliver measurable improvements in productivity, quality, standardization, and cycle time through continuous improvement and operational excellence initiatives

Director of Manufacturing Engineering - Connection Systems North America

Aptiv is a global technology company that develops safer, greener, and more conn...

Location

United States , Troy, MI; Warren, OH

Salary:

Not provided

Aptiv plc

Expiration Date

Until further notice

Requirements

10–15+ years in fast-paced, B2B manufacturing (preferably automotive) with expertise in complex, global operations and customer relationships
Prior experience in one or more key manufacturing processes - high speed precision metal stamping, plastic molding, PCBA and electronic assemblies - is a desired
Proven regional leadership experience in quality and manufacturing
Global experience highly desired
Hands-on experience leading transformational projects and change
Education: Bachelor’s in Engineering preferred
Master’s highly desired
Six Sigma certification (Green or Black Belt)
Business Acumen: Strong customer and business focus
ability to develop strategies and deliver on commitments

Job Responsibility

Define and refine manufacturing process strategy
establish CoEs for molding, stamping, component assembly and electronic assembly
Lead forward planning, NA Capex, and process excellence
provide timely inputs to commercial quotes
manage tactical plans and capital/expense control
Ensure successful manufacturing process launches meeting cost, quality, and performance targets
Oversee development and construction of prototypes
Support initiatives for world-class manufacturing processes and optimized value streams
Collaborate with Product Engineering, Product Management, Finance, Quality, and Operations to drive profitable revenue growth
Recruit, coach, and develop team members

Fulltime

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Director, Manufacturing Execution

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