Sr Associate, Manufacturing Regulatory Job at Alfasigma (Pomezia)

Sr Associate Regulatory Affairs - CMC

If you feel like you're part of something bigger, it's because you are. At Amgen...

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Background in CMC related functions (e.g., Quality, Manufacturing, etc) with limited or no prior Regulatory Affairs experience
Curious, proactive, confident in tackling new challenges, and comfortable working collaboratively in a fast-paced learning environment
Developed project management and organizational skills
Strong and effective oral and written communication skills

Job Responsibility

Contribute as a key member of the global regulatory CMC product team
Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
Document and archive CMC submissions and related communications in the document management system
Initiate and maintain CMC product timelines at the direction of product lead
Interface with the regulatory operations team
Train staff on select CMC procedures and systems
Provide report status of activities and projects to teams and department
Participate in cross-functional special project teams

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Sr Manufacturing Associate, Downstream

Be the driving force behind seamless logistics with our client where precision a...

Location

United States , Bristol

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's degree in chemistry, biology or engineering
A minimum of 6+ years' experience in a GMP pharmaceutical environment
Experience in normal flow filtrations and tangential flow filtrations (UF/DF)
Experience with optimization of bioprocesses
Direct hands-on experience with preparative chromatography systems (AKTA Pilot, AKTA Ready, AKTA Explorer, etc.), and manual or automated TFF skids
Experience with cGMP manufacturing operations and GxP principles
Understanding and application of cGMP requirements

Job Responsibility

Works in GMP environment and ensures regulatory compliance
Performs Manufacturing activities including: Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs, and Batch Records
Batch Documentation/Record Generation
Materials sampling, staging, dispensing, and return
Equipment and Room set-up, operation, and cleaning
Use of appropriate personal safety equipment and engineering controls
In-process inspection and sampling
Support investigational and quality systems activities
Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment
Participate in continuous improvement activities

Fulltime

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...

Location

United States , Thousand Oaks

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Manufacturing support experience
Associate’s + 2 years Manufacturing support experience
Bachelor’s + 6 months Manufacturing support experience
Master's
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Knowledge of process validation, deviation management, and change control
Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Sr Associate QA I

Sr Associate QA I at Amgen in Holly Springs, North Carolina. This is an on-site ...

Location

United States , Holly Springs

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Associate's + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Bachelor's + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience OR Master's

Job Responsibility

Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
Oversee and provide guidance during on-the-floor analytical testing
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Sr. Manufacturing Manager

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Puerto Rico , Aibonito

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree required - MBA preferred - 10+ years manufacturing/operations experience including 3 years of leading leaders
Fully bilingual in English and Spanish, with the ability to effectively communicate—both verbally and in writing—in both languages
Demonstrated ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents
Skilled in responding to inquiries or concerns from customers, regulatory agencies, and members of the business community in a professional and timely manner
Strong professional writing and communication skills including reports, presentations, speeches, and articles, ensuring alignment with established style and format standards
Proven capability to clearly present complex information to diverse audiences
Lead multiple priorities in a manufacturing plant setting
analyze and draw conclusions from scientific and statistical data
Apply data analysis to solve problems and make strategic decisions
understand GMPs and other applicable regulatory guidelines and ability to handle audit-related activities

Job Responsibility

Establishes, or recommends to management, major corporate manufacturing strategies, objectives, and policies for company
Support the rollout of a Total Predictive Maintenance program to minimize equipment failures associated to predictable tendency
Review production timetables and manages manufacturing activities to ensure production schedule adherence and quality of products align with specifications
Reviews manufacturing engineering performance reports and resolves technical and upkeep issues to ensure minimum costs and prevent operational delays
Directs preparation of budgets, reviews budget proposals, and prepares necessary supporting documentation and justification
Drive value improvement programs
Reviews production schedules to ascertain product data such as types, quantities, and specifications of products and scheduled delivery dates in order to plan department operations
Plans production operations, establishing priorities and sequences for manufacturing products
Prepares operational schedules and coordinates production processes to ensure that the quality and output of products meet specifications
Reviews production and operating reports and addresses operational, manufacturing, and maintenance problems to keep costs low and avert operational delays

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Sr Associate Scientist, Cell Culture

Play a key role in advancing and optimizing autologous cell‑based therapy proces...

Location

United States , Cambridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's degree in a science‑related field (Biology, Biochemistry, Biotechnology, or similar)
Hands‑on experience with aseptic cell culture and primary human immune cell culture
Working knowledge of cell therapy bioreactor systems and scale‑up concepts
Proficiency in flow cytometry and cell counting methodologies
Strong organizational skills with the ability to work effectively in fast‑paced, cross‑functional environments

Job Responsibility

Independently design, execute, and manage laboratory experiments involving primary human immune cell isolation, cell activation, genetic modification, cell expansion and cryopreservation
Apply statistical and data visualization techniques to analyze results, assess process performance, and draw data‑driven conclusions
Support process development and scale‑up efforts to translate benchtop cell culture workflows into manufacturing‑relevant processes
Perform multi‑color flow cytometry and cell‑based assays to characterize cell therapy drug products and evaluate process performance
Maintain accurate, complete, and compliant laboratory documentation in alignment with internal policies and regulatory expectations
Contribute to daily laboratory operations, continuous improvement initiatives, and feasibility assessments for new process concepts
Assist with laboratory equipment upkeep, safety practices, and general lab organization to maintain an efficient working environment

Fulltime

Sr. Associate I, Quality Control

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions
To ensure that preparation of reagents and volumetric solution and standardization on time
To perform periodic observation of retained sample
To initiate Change control (CcM), Non conformation report (NCR), Out of Specification (OOS), Document change record (DCR) etc.. QMS related documents
To do the work allocation in shift and ensure it complete within timeline
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines
To review results of the tests against the specification & standard test procedure performed by team members
To investigate out of specification (OOS), Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions
To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC
To ensure availability the working & impurities standards as per various pharmacopoeias

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Sr. Associate I, Quality Control

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions
To ensure that preparation of reagents and volumetric solution and standardization on time
To perform periodic observation of retained sample
To initiate Change control (CcM), Non conformation report (NCR), Out of Specification (OOS), Document change record (DCR) etc.. QMS related documents
To do the work allocation in shift and ensure it complete within timeline
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines
To review results of the tests against the specification & standard test procedure performed by team members
To investigate out of specification (OOS), Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions
To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC
To ensure availability the working & impurities standards as per various pharmacopoeias

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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Sr Associate, Manufacturing Regulatory

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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