Drug Product Manufacturing Associate I Job at PCI Pharma Services (San Diego)

Drug Product Manufacturing Associate I

The Manufacturing Associate I is responsible for executing GMP production of inj...

Location

United States , San Diego

Salary:

21.98 - 25.64 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

Requirements

High school diploma required
Bachelors in a science or engineering discipline preferred
Minimum of zero to two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions
Ability to follow instructions with direct supervision
Detail oriented with strong written and verbal communication skills
Demonstrated ability to follow detailed directions in a manufacturing GMP environment
Familiarity with cGMP, manufacturing, machine operations, and data entry
Must be familiar with Microsoft Office applications

Job Responsibility

Train in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility
Train on required SOP's and execute training curriculum
Prepare materials needed for aseptic operations
Performs various routine manufacturing tasks on complex equipment under the guidelines of established SOP’s and cGMP regulations
Accurately documents data and completes batch records as needed
Reliably executes well defined SOP’s
Operates in clean room environments in accordance with established policies and procedures
Collects and disposes of lab wastes according to established procedures
Regular and reliable attendance on a full time basis [or in accordance with posted schedule]
Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture

What we offer

Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k) plan
Eligibility for an annual performance bonus

Fulltime

Senior Associate Manufacturing, Drug Product

At Amgen, our mission—to serve patients—drives everything we do. As a Sr Associa...

Location

United States , Thousand Oaks

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master's degree OR Bachelor's degree and 6 months of Manufacturing support experience OR Associate's degree and 2 years of Manufacturing support experience OR High school diploma / GED and 4 years of Manufacturing support experience

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen's electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
Support timely investigation and resolution of manufacturing deviations

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Drug Product Manufacturing Associate II

The Manufacturing Associate II is responsible for executing GMP production of in...

Location

United States , San Diego

Salary:

27.09 - 31.60 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

Requirements

High school diploma required
Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions
Ability to work with cross functional teams
Detail oriented with strong written and verbal communication skills
Ability to work independently, within prescribed guidelines, or as a team member
Demonstrated ability to follow detailed directions in a manufacturing GMP environment
Familiarity with cGMP, manufacturing, machine operations, and data entry
Must be familiar with Microsoft Office applications
Ability to constantly perform duties while donning aseptic gowning
Ability to constantly sit and reach to use computers and other office equipment

Job Responsibility

Execute GMP production of injectable pharmaceuticals by following all applicable SOP's
Prepare equipment and materials for GMP aseptic production
Operate equipment such as glasswashers, autoclaves, depyrogenation ovens and automated filling machines
Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility
Assist technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment
Perform various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations
Troubleshoot manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management
Assist in the research and implementation of new methods and technologies to enhance operations
Prepare components, media, buffers, and other solutions as needed
Accurately document data and write/review batch records under cGMP guidelines

What we offer

Eligibility for an annual performance bonus
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k) plan

Fulltime

Drug Product Manufacturing Associate II

The Manufacturing Associate II is responsible for executing GMP production of in...

Location

United States , San Diego

Salary:

27.09 - 31.60 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

Requirements

High school diploma required
Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions
Ability to work with cross functional teams
Detail oriented with strong written and verbal communication skills
Ability to work independently, within prescribed guidelines, or as a team member
Demonstrated ability to follow detailed directions in a manufacturing GMP environment
Familiarity with cGMP, manufacturing, machine operations, and data entry
Must be familiar with Microsoft Office applications
Constantly perform duties while donning aseptic gowning
Constantly required to sit, and to reach to use computers and other office equipment

Job Responsibility

Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility
Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment
Performs various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations
Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management
Assists in the research and implementation of new methods and technologies to enhance operations
Prepares components, media, buffers, and other solutions as needed
Accurately documents data and writes/reviews batch records under cGMP guidelines
Prepares material components for production
Regular and reliable attendance on a full time basis [or in accordance with posted schedule]
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices

What we offer

Eligibility for an annual performance bonus
Paid time off
Health insurance coverage (including dental and vision)
A flexible spending account
A 401(k) plan

Fulltime

Manufacturing Associate, Drug Substance - Shift Position

As a Manufacturing Associate at our Harwell site, you will operate cutting-edge ...

Location

United Kingdom , Oxford

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

1+ years of experience in a GMP manufacturing environment
A university degree with a specialization in Pharmaceutical production technology or equivalent
Ability to collaborate fluidly with peers, leadership and cross-functional support groups
Excellent written, oral communication, and organizational skills
Ability to maintain attention to detail while executing multiple tasks with minimal supervision
Demonstrated commitment to Moderna's values of Bold, Collaborative, Curious, and Relentless

Job Responsibility

Operate and monitor production equipment while adhering to cGMP, SOPs, and health and safety procedures
Maintain a clean, compliant, and safe work environment through strict adherence to gowning and housekeeping standards
Execute operations and maintain accurate manufacturing documentation for batch disposition
Perform routine equipment maintenance such as lubrication, filter changes, and mechanical checks using hand-tools
Troubleshoot digital and equipment-related issues rapidly and efficiently
Keep training records and operational logs up to date, ensuring full compliance
Work flexibly including off-hours or overtime to support manufacturing schedules
Take part in deviation investigations (RCA), CAPA tasks, and contribute to incident analyses
Collaborate closely with QA and other cross-functional teams to meet production KPIs

What we offer

Best-in-class healthcare
voluntary benefit programs
Access to fitness, mindfulness, and mental health support
Family building benefits including fertility, adoption, and surrogacy support
Generous paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
Location-specific perks and extras

Fulltime

Associate Manufacturing - Bulk Drug Substance Downstream - Days

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

70985.20 - 96038.80 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School/GED + 2 years manufacturing and/or other regulated environment experience
Or Associate's Degree + 6 months manufacturing and/or other regulated environment experience
Or Bachelor's Degree
Completion of NCBioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility
Excellent verbal and written communication
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Job Responsibility

Completes work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream bio-tech operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify and escalate issues and concerns regarding daily routine functions related to process and tasks
may engage with team on potential solutions
Perform documentation for assigned functions

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Location

United States , Holly Springs

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
Associate's Degree + 2 years manufacturing and/or other regulated environment experience
Bachelor's Degree + 6 months manufacturing and/or other regulated environment experience
Master's Degree

Job Responsibility

Completes work in accordance with established cGMP procedures and policies
Initiate quality non-conformance (NC) reports
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Associate Manufacturing - Bulk Drug Substance Downstream

Let’s do this. Let’s change the world. In this dynamic role, you will be a Senio...

Location

United States , Holly Springs

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR Master's Degree

Job Responsibility

Execute on-the-floor operations within manufacturing in accordance with cGMP practices
Complete work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
Initiate quality non-conformance (NC) reports
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream biotech operations including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation
Complete washroom activities
Initiate and own manufacturing related process deviations
Identify, recommend, and implement innovative process improvements and optimizations

Fulltime

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Drug Product Manufacturing Associate I

Job Description

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Drug Product Manufacturing Associate I

Drug Product Manufacturing Associate I

Senior Associate Manufacturing, Drug Product

Drug Product Manufacturing Associate II

Drug Product Manufacturing Associate II

Manufacturing Associate, Drug Substance - Shift Position

Associate Manufacturing - Bulk Drug Substance Downstream - Days

Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Senior Associate Manufacturing - Bulk Drug Substance Downstream

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