Jobs in the United States

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Added 1 min ago
PS
Tech Distribution Design Supervisor
Public Service Co. of Colorado
Fort Collins, CO · Boulder, CO · Greeley, CO
- $84,900 to $120,566.66 USD / year
…of Design resources, tools and processes. Provide resident technical matter expertise, and real-time technical support services to planning, Right Of Way, construction and operations for…
Added 1 min ago
SC
Grants Manager
Storey, County of (NV)
Virginia City, NV
- $39.42 USD / hour
Under general supervision, performs a variety of professional and technical duties involved in grant oversight, administration, and procurement of services for funding granted to County…
Added 2 mins ago
PS
Treasury Systems Analyst
Primoris Services Corporation
Irvine, CA
- $96,000 to $153,000 USD / year
Partner with technical resources to implement and maintain integrations and automated data exchange processes.
Added 3 mins ago
DO
Unit Chief
Department of Toxic Substances Control
CA
- $10,854 to $13,493 USD / month
As of July 1st, 2026, the position is office-centered, and employees will be expected to report to the office at least four days per week
Added 3 mins ago
Construction Project Manager
d PETNET Solutions, Inc.
United States
Plans, prepares and coordinates tecchnical projects according to the Project Management (PM) standards defined, throughout all stages of the Q-gate process.This is a role well suited to an…
Added 5 mins ago
Project Associate (2nd Shift)
Align Communications
MI
Working closely with the lead Project Manager and daytime team, this person will serve as Align’s onsite point of contact during the second shift. The role requires someone who is…
Added 5 mins ago
CO
Assistant Director of General Services
City of Portsmouth
Portsmouth, VA
- $90,393.55 to $116,370.6 USD / year
Assists with the development of proposals and reports as requested by City Manager and City Council and presents recommendations to City Management, City Council and to other groups.…
Added 6 mins ago
NB
Project Manager, Security Operations
Ntiva Branding
Mc Lean, VA
- $80,000 to $110,000 USD / year
The Project Manager, Security Operations is a newly created role, and it is the first dedicated project management position within Ntiva’s Security Operations team. You will be the primary…
Added 8 mins ago
Quality Engineering Manager
Johnson & Johnson Surgical Vision Inc. Legal Entity
Jacksonville, FL
The Quality Engineering Manager provides quality leadership and technical oversight for the Jacksonville Intraocular Lens (IOL) manufacturing operation, ensuring that products, processes,…
Added 9 mins ago
Supervisor Gas Control (Anchorage)
ENSTAR Natural Gas Company
Anchorage, AK
Under the direction of the Senior Manager Pipelines, supports the Engineering Department with long and short term resource and strategy planning, project development, cost-benefit analysis,…
Added 9 mins ago
Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Tysons Corner, VA
Our capabilities include program, project, cost, asset and commercial management, controls and performance, procurement and supply chain, net zero and digital solutions.
Added 9 mins ago
Senior Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Petersburg, VA
To be successful in this role you must have excellent communication skills and be comfortable operating in a client-facing environment
Added 9 mins ago
Senior Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Chester, VA
To be successful in this role you must have excellent communication skills and be comfortable operating in a client-facing environment
Added 9 mins ago
Senior Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Midlothian, VA
To be successful in this role you must have excellent communication skills and be comfortable operating in a client-facing environment
Added 9 mins ago
Senior Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Washington D.C., DC
Turner & Townsend is seeking an experienced Senior Cost Manager / Quantity Surveyor to serve as the key day-to-day client interface on a large-scale mission-critical data center…
Added 9 mins ago
Senior Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Richmond, VA
Turner & Townsend is seeking an experienced Senior Cost Manager / Quantity Surveyor to serve as the key day-to-day client interface on a large-scale mission-critical data center…
Added 10 mins ago
Project Manager-IT II
Eisenhower Medical Center
United States
Required: Project Manager Professional (PMP) Certification
Added 10 mins ago
Embedded Software Engineer – Avionics Displays (C++)
Aerospace
Phoenix, AZ
YOU MUST HAVE
Added 11 mins ago
A
External Manufacturing Manager
Amneal
Piscataway, NJ
- $150,000 to $160,000 USD / year
The Manager, External Manufacturing Operations (EMO) is the primary operational contact for assigned contract manufacturing organizations (CMOs/CDMOs), products, and manufacturing programs.…
Added 11 mins ago
RM
Electrical Trainee Lvl 3
Rex Moore Group, Inc.
San Francisco, CA
- $19.58 to $39.38 USD / hour
Effectively communicates technical information with peers, assistants, project supervision & other trades
Added 12 mins ago
SI
Lead Industry Solution Specialist
Salesforce, Inc.
Remote, United States
- $134,750 to $231,980 USD / year
Project manage solution engineering SMEs as they participate in the demo process and our demo programs. Build & provide templates, enablement, etc to support the program.
Added 12 mins ago
Lead Generator Project Engineer-1
GE Gas Turbines (Greenville) L.L.C.
United States
The Lead Generator Project Engineer provides technical project management, technical direction, and drives coordination of engineering activities and critical issue resolution for…
Added 12 mins ago
Lead Generator Project Engineer-2
GE Gas Turbines (Greenville) L.L.C.
United States
The Lead Generator Project Engineer provides technical project management, technical direction, and drives coordination of engineering activities and critical issue resolution for…
Added 12 mins ago
Lead I&C System Engineer
GE Vernova Hitachi Nuclear Energy Americas LLC
United States
Support project engineering or manager with understanding execution metric and status, issues, risks, mitigation or recovering plans, and be extremely proactive to identify changes in scope.
Added 12 mins ago
Senior Product Growth Manager - Product Security (Houston, TX)
Hewlett Packard Enterprise
Spring, TX
This role has been designed as 'Hybrid' with a requirement that you will work on average 2 days per week from an HPE office

Amneal

External Manufacturing Manager

Piscataway, NJ, United States

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

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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.

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Jobs in the United States