Jobs in the United States

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Added 1 min ago
Engineering Manager (Weekend)
Ralliant
Hollister, CA · Hollister
The Engineering Manager (Weekend) position is a key technical leadership role within PacSci EMC. The Engineering Manager provides leadership to and participates on a team of engineering…
Added 2 mins ago
Manager Performance and Insights
Jackson National Life Insurance
Lansing, MI
The Manager, Performance and Insights leads the development, analysis, and reporting of operational metrics that support Facilities, Corporate Real Estate, and planning functions. This role…
Added 3 mins ago
SC
Senior Budget Management Consultant (Manager IV)
Stanislaus County
Modesto, CA
- $51.22 to $76.84 USD / hour
Stanislaus County is currently accepting applications for the position of Senior Budget Management Consultant (Manager IV) in the Chief Executive Office. The Senior Budget Management…
Added 4 mins ago
Associate Product Manager, New Grad
Bask Health
Remote, United States
Maintain product documentation, project updates, and development priorities.
Added 4 mins ago
Associate Product Manager
Bask Health
Remote, United States
We're looking for an Associate Product Manager to help build, launch, and improve products across Bask's telehealth platform.
Added 4 mins ago
Apprentice Product Manager
Bask Health
Remote, United States
…initiative, and wants to develop into a strong technical product manager. You'll gain exposure to product discovery, technical planning, development, testing, and launches while…
Added 5 mins ago
PC
Crisis Clinical Program Manager
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San Jose, CA
- $106,022 to $130,394 USD / year
…external, such as local law enforcement, by supporting the development of constructive relationships and problem-solving…
Added 6 mins ago
Employee Benefits Account Manager
HM Hub International Texas
Argyle, TX
**This is a hybrid role, requiring three days per week in the office.** · L&H License required (or obtained after 90 days)
Added 7 mins ago
Manufacturing Systems Engineering (MSE) Manager – Level 3
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Dulles · Gilbert
Northrop Grumman’s Space Sector is seeking a Manufacturing Systems Engineering (MSE) Manager – Level 3 to join our team. The primary location(s) of the work will be in Dulles, VA and…
Added 7 mins ago
Manager 1 - Electromechanical Design - Linthicum
Northrop Grumman
Linthicum Heights
Must have ability to obtain and maintain a TS/SCI security clearance
Added 7 mins ago
Lead Systems Engineer Space Superiority
Northrop Grumman
Dulles
…execution of all systems engineering functions for the design, development and deployment of space vehicle systems as well as the spokesperson for all other engineering disciplines on the…
Added 9 mins ago
MI
Sr Training Coordinator
Medline Industries, LP
Southaven, MS
- $21.25 to $30.75 USD / hour
Administer new hire and hiring manager surveys regarding recruiting and on-boarding process and compile reports
Added 9 mins ago
Manager, Cloud and Platform Security
KPMG LLP
Miami, FL · Orlando, FL · Tallahassee, FL · Tampa, FL
…within the practice, fostering both personal and professional development, thereby creating new pathways for growth. In this ever-changing market environment, our professionals must be…
Added 9 mins ago
Manager, ServiceNow Veza Identity Governance Engineer
KPMG LLP
Miami, FL · Orlando, FL · Tallahassee, FL · Tampa, FL
…within the practice, fostering both personal and professional development, thereby creating new pathways for growth. In this ever-changing market environment, our professionals must be…
Added 9 mins ago
Manager, Customer Identity and Access Management - Okta & Entra
KPMG LLP
Miami, FL · Orlando, FL · Tallahassee, FL · Tampa, FL
…within the practice, fostering both personal and professional development, thereby creating new pathways for growth. In this ever-changing market environment, our professionals must be…
Added 9 mins ago
Manager, Access Management - Okta & Entra
KPMG LLP
Miami, FL · Orlando, FL · Tallahassee, FL · Tampa, FL
…within the practice, fostering both personal and professional development, thereby creating new pathways for growth. In this ever-changing market environment, our professionals must be…
Added 9 mins ago
VP, Cloud IAM Engineering Leader
Synchrony Bank
Stamford Engagement Hub, CT · Chicago Engagement Hub, IL · Orlando Engagement Hub, FL · NYC Bryant Park Engagement Hub, NY · Cincinnati West Chester Engagement Hub, OH · Charlotte Engagement Hub, NC · Atlanta Engagement Hub, GA
Serve as the people manager for the Cloud IAM Engineering team, including coaching, development, performance management, workforce planning, and team engagement.
Added 10 mins ago
MS
Epic Willow Ambulatory Applications Analyst III- Digital and Technology Partners - Remote
Mount Sinai Health Systems
New York, NY
- $99,200 to $148,800 USD / year
DescriptionThe Applications Analyst III supervises and provides technical guidance to the staff in the development of specifications for new or revised systems.
Added 10 mins ago
WS
Site Manager | Pioneer Middle School | (Walla Walla, WA)
Washington State University
Richland, WA
- $4,743.82 to $5,483.55 USD / month
Washington State University Tri-Cities GEAR UP program is now accepting applications for a Site Manager at Pioneer Middle School in Walla Walla, WA. As a Site Manager, you will be…
Added 11 mins ago
Mechanical Engineer
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Oakland, CA · Golden, CO · Houston, TX
…utility-scale enhanced geothermal systems. Our flagship Cape Station development in Utah is planned to deliver 500 MW of firm, carbon-free power, and we are advancing a development pipeline…
Added 11 mins ago
Lead Designer, Basketball Graphic Design, Global Jordan
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…effective solutions. Strong presentation skills, disciplined project management and the ability to meet multiple deadlines are…
Added 12 mins ago
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Facilities Manager III
Stanford Health Care
United States
- $68.52 to $90.78 USD / hour
The Facility Manager III is the key point of contact for the customer regarding facilities matters; they manage, supervise and aggregate internal and external services for delivery to the…
Added 13 mins ago
Technical Product Specialist, Digital
RAIZ FEDERAL CREDIT UNION
El Paso, TX
Must have good communication and interpersonal skills
Added 16 mins ago
Design Manager
CREATIVE OFFICE PAVILION LLC
New York, NY
The Design Manager is responsible for supporting the sales effort, driving client meetings and interface, providing space planning and furniture application services, determining and…
Added 17 mins ago
Regional Safety Group Manager
General Motors LLC
Warren, MI · Pasadena, CA · San Francisco, CA · Palo Alto, CA
The Enterprise Operations Regional Safety Manager leads safety strategies and day-to-day safety operations across the global GM enterprise in their assigned regions, sites, and functions.…

Amneal

External Manufacturing Manager

Piscataway, NJ, United States

$150,000 to $160,000 USD / year

Apply on hcfa.fa.us2.oraclecloud.com About employer

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Job details

Pay: $150,000 to $160,000 USD / year
Posting language: English
Posted: Nov 10, 2026

Original job description

The Manager, External Manufacturing Operations (EMO) is the primary operational contact for assigned contract manufacturing organizations (CMOs/CDMOs), products, and manufacturing programs. This hands-on role coordinates routine manufacturing execution, technology transfer, campaign readiness, issue resolution, and partner performance to support reliable supply and compliant delivery of biologic drug substance and/or drug product.

The Senior Manager works through a matrix and partners closely with Manufacturing, Quality, MSAT, Supply Chain, Regulatory, CMC Development, Procurement, Legal, and Finance. The role executes approved external-manufacturing strategy for an assigned portfolio, recommends improvements, and escalates decisions that require broader network, contractual, financial, or product-disposition authority. During critical campaigns, the Senior Manager may provide on-site person-in-plant support at external manufacturing facilities.

What You Will Own

Day-to-day operational governance of assigned CMO/CDMO relationships, products, and manufacturing campaigns.
Manufacturing schedules, readiness milestones, action tracking, risk visibility, and cross-functional follow-through for the assigned portfolio.
Routine partner meetings, operational reviews, escalation coordination, and performance reporting.
Operational support for technology transfer, validation, process changes, investigations, and continuous improvement.
Clear communication of manufacturing status, supply risks, decisions, and required actions to internal stakeholders and leadership.

Essential Duties & Responsibilities:

CMO Operations and Partner Performance

Serve as the primary operational contact for assigned external manufacturing partners and maintain productive, accountable working relationships.
Coordinate day-to-day manufacturing activities against approved production schedules, supply priorities, quality requirements, and program objectives.
Lead routine operating meetings and contribute to quarterly or periodic business reviews using agreed metrics, risks, actions, and decisions.
Monitor partner performance, including schedule adherence, on-time delivery, yield, right-first-time execution, deviation closure, and action-item completion.
Identify execution risks early, develop practical mitigation plans with internal and external teams, and escalate issues through the appropriate governance pathway.
Provide on-site person-in-plant support during selected engineering, validation, clinical, or commercial manufacturing campaigns when needed.

Technology Transfer and Manufacturing Execution

Coordinate operational readiness for technology transfers, scale-up, process validation, PPQ, new-product introductions, and lifecycle changes at assigned CMOs.
Partner with MSAT, CMC Development, Engineering, Quality, and Regulatory colleagues to confirm that technical deliverables, documentation, materials, equipment, training, and facility readiness are aligned before execution.
Track transfer plans, validation milestones, dependencies, risks, and decisions; maintain clear ownership and due dates across the project team.
Support manufacturing troubleshooting and facilitate timely resolution of technical and operational issues without replacing the accountable Quality, MSAT, Regulatory, or product-disposition functions.
Capture lessons learned and implement repeatable tools, templates, and operating practices across the assigned portfolio.

Quality, Compliance, and Regulatory Support

Ensure assigned manufacturing activities are planned and executed in accordance with cGMP, approved procedures, quality agreements, and applicable regulatory requirements.
Partner with Quality to support deviations, investigations, CAPAs, change controls, complaints, audits, and inspection-readiness activities.
Monitor the operational impact of quality events and coordinate recovery plans that protect patients, product quality, compliance, and supply continuity.
Participate in audits and regulatory inspections as an operations representative or subject-matter contributor when requested.

Supply, Cost, and Cross-Functional Coordination

Partner with Supply Chain to align demand, production, release, shipment, inventory, and material-readiness requirements for assigned products.
Provide timely visibility to capacity constraints, schedule changes, material risks, and potential supply interruptions.
Track costs, purchase-order or statement-of-work milestones, and budget impacts within the assigned portfolio; partner with Finance, Procurement, and Legal on commercial decisions and contract changes.
Identify practical opportunities to improve cost, efficiency, cycle time, quality, and partner performance, and develop recommendations for leadership approval when required.
Communicate clearly across Manufacturing, Quality, Regulatory, Supply Chain, MSAT, R&D, CMC Development, Finance, Procurement, and Legal.

Role Scope and Decision Boundaries

The initial scope is a defined portfolio of assigned CMO/CDMO partners, products, or programs, with the opportunity to expand as the external-manufacturing portfolio grows.
The Senior Manager executes approved strategy and recommends changes. Network strategy, major capital decisions, final contract authority, and enterprise portfolio prioritization remain with senior leadership and the appropriate functional owners.
The role leads primarily through matrix influence. Direct supervisory responsibility may be added as the organization and portfolio grow.
Quality retains independent authority for quality-system decisions and product disposition. The Senior Manager coordinates operational response and supply recovery in partnership with Quality and other accountable functions.

Minimum Qualifications:

Education:

Bachelor's degree in engineering, biotechnology, biology, biochemistry, pharmaceutical sciences, life sciences, or a related discipline.

Experience:

At least 10 years of experience in biomanufacturing, pharmaceutical manufacturing, technical operations, MSAT, supply operations, or another regulated life-sciences environment.
At least 8 years of experience working in a GMP-regulated environment.
Meaningful experience supporting or managing external manufacturing, CDMO/CMO relationships, outsourced manufacturing programs, or sponsor-CDMO operations.
Working knowledge of biomolecule manufacturing, including one or more of the following: cell culture, fermentation, purification, formulation, aseptic processing, fill-finish, or biologic drug-product manufacturing.
Experience coordinating manufacturing schedules, campaign readiness, technology transfer, validation, change control, deviations, CAPAs, or lifecycle activities.
Demonstrated ability to lead cross-functional work through influence, establish accountability, resolve issues, and communicate effectively with technical and business stakeholders.
Ability to travel occasionally and provide on-site support at external manufacturing facilities during critical activities.

Preferred Qualifications:

Master's degree, MBA, or other relevant advanced degree.
Three or more years of direct experience coordinating or managing one or more biologics CMO/CDMO relationships or outsourced manufacturing programs.
Experience supporting clinical and/or commercial biologics, biosimilars, vaccines, cell and gene therapies, or other complex sterile products.
Experience with partner scorecards, operational reviews, supply-risk mitigation, statements of work, purchase orders, cost tracking, or capacity planning.
Experience serving as a technical or operational lead during CMO manufacturing campaigns, technology transfers, validation, PPQ, inspections, or major investigations.
People leadership, mentoring, or team-development experience. Formal direct-report management is helpful but not required if strong matrix leadership is demonstrated.

Hours:

This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

Work is performed in office and operational manufacturing environments.
The position requires movement through manufacturing facilities and the ability to lift at least 25 pounds.
Occasional travel is required. Additional on-site presence may be necessary during selected manufacturing campaigns, technology transfers, investigations, or inspections.
The role operates in a fast-paced environment with time-sensitive manufacturing, quality, and supply priorities.

The salary range for this position ranges from $150,000 - $160,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.

Apply on hcfa.fa.us2.oraclecloud.com About employer

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Jobs in the United States