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Manager, Manufacturing Science & Technology

Amneal Pharmaceuticals, Inc.Brookhaven, NY

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Overview

Schedule
Full-time
Career level
Director
Remote
On-site
Benefits
Career Development

Job Description

Description:

This role provides technical leadership and hands on support for sterile manufacturing operations, including Blow Fill Seal, prefilled syringe filling, sterile bag filling, formulation, sterile filtration, aseptic processing, component preparation, visual inspection, and related process interfaces. This role ensures sterile processes are scientifically sound, validated, robust, compliant, and continuously improved, serving as a technical bridge between Manufacturing, QA, QC Microbiology, Engineering, Validation, Regulatory Affairs, Supply Chain, and Product Development/Technology Transfer.

Essential Functions:

  • Provide technical support for sterile operations (BFS, prefilled syringes, bag filling, formulation, filtration, aseptic transfers, filling setup, container closure, visual inspection)
  • Lead or support validation lifecycle activities (PPQ, CPV, monitoring, trending) and manage tech transfer, scale up, site transfer, new product introduction, and lifecycle management
  • Serve as MS&T SME for deviations, non conformances, OOTs, failures, yield losses, contamination events; lead investigations, impact assessments, CAPAs, and batch disposition support
  • Establish and improve control strategies (CPPs, CQAs, IPCs, parameters, criteria) and support contamination control, APS, EM trending, cleanroom controls, and sterile assurance investigations
  • Partner with Engineering, Manufacturing, Validation, QA, and Automation on equipment qualification, process improvements, facility upgrades, and manufacturing readiness; lead or support change control assessments
  • Author/review technical documents (protocols, reports, SOPs, risk assessments, CPV, investigations), support audits and regulatory inspections, and provide technical coaching to junior staff and project teams

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FAQs About Manager, Manufacturing Science & Technology Jobs at Amneal Pharmaceuticals, Inc.

What is the work location for this position at Amneal Pharmaceuticals, Inc.?
This job at Amneal Pharmaceuticals, Inc. is located in Brookhaven, NY, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Amneal Pharmaceuticals, Inc.?
Employer has not shared pay details for this role.
What employment applies to this position at Amneal Pharmaceuticals, Inc.?
Amneal Pharmaceuticals, Inc. lists this role as a Full-time position.
What experience level is required for this role at Amneal Pharmaceuticals, Inc.?
Amneal Pharmaceuticals, Inc. is looking for a candidate with "Director" experience level.
What benefits are offered by Amneal Pharmaceuticals, Inc. for this role?
Amneal Pharmaceuticals, Inc. offers Career Development for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Amneal Pharmaceuticals, Inc.?
You can apply for this role at Amneal Pharmaceuticals, Inc. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.