CrawlJobs Logo

Sr Manufacturing Associate, Downstream

proclinical.com Logo

Proclinical

Location Icon

Location:
United States , Bristol

Category Icon
Category:
Manufacturing

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

Be the driving force behind seamless logistics with our client where precision and efficiency are key to supporting world-class manufacturing. Proclinical is seeking a Sr Manufacturing Associate to be responsible for performing large-scale bioconjugation processes for cGMP manufacturing projects.

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
  • Interfaces and consults with other functions, such as process development, Quality Control and Quality Assurance
  • Initiates deviations, assists in assessing product quality impact and assists with proposals for Corrective and Preventive Actions (CAPAs)
  • Writes, reviews SOPs and other applicable cGMP documentation for Manufacturing
  • Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols
  • Ensures completion of equipment logs and batch records
  • Ensures cleanliness and proper assembly of manufacturing equipment and manufacturing areas per approved procedures (SOP's)
  • Ensures accuracy of Standard Operating Procedures (SOP's)
  • Trains on and understand all policy and procedures including Regulatory, Safety, SOPs, Work Instructions, etc.
  • Operate to the highest ethical and moral standards
  • Comply with our policies and procedures
  • Communicate effectively with clients, supervisors, colleagues and staff
  • Participate effectively as a team player in all aspects of our business
  • Adhere to quality standards set by regulations and our policies, procedures, and mission
  • Perform other duties as assigned

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

Additional Information:

Job Posted:
March 20, 2026

Employment Type:
Fulltime
Icon
Proclinical - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Sr Manufacturing Associate, Downstream

Mq ts downstream associate

The MQ TS Downstream Associate is responsible for primary contact of quality on ...
Location
Location
India , Vizag
Salary
Salary:
Not provided
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • M. Pharma / Msc with more than 1 year experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility
  • Experience in the pharmaceutical industry and Quality administered systems
  • Sound knowledge of current Good Manufacturing Practices (part of GxP)
  • Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
  • Effective written and oral communication skills.
Job Responsibility
Job Responsibility
  • Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations
  • Maintain regulatory compliance in accordance with cGMP practices
  • Ensure manufacturing policies and procedures conform to Pfizer standards
  • Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Associate or Sr. Team Leader
  • Review of Batch reports and Equipment audit trails
  • Perform Acceptable Quality level sampling, Inspection in VIDT and Batch record review and release
  • Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc
  • Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging
  • Perform Daily walkthroughs and report observations to the Sr. Team Leader
  • Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Associate or Sr. Team Leader
  • Fulltime
Read More
Arrow Right

Sr Associate Quality Assurance

In this vital role you will be the Sr. Associate Plant Quality Assurance (PQA) o...
Location
Location
United States , Holly Springs
Salary
Salary:
86928.00 - 106536.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience
  • Associate’s + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience
  • Bachelor’s + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience
  • Master's
  • Strong cGMP and GDP behaviors
  • Experience in biotechnology or pharmaceutical plant start up
  • Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
  • Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
  • Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
  • Demonstrated experience with deviations records
Job Responsibility
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
  • Drive closure/completion of cGMP processes, procedures, documents and records
  • Ensure production and testing records/results are complete, accurate, and documented according to procedures
  • 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
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
Read More
Arrow Right

Sr Engineer, Process Development

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States , Holly Springs
Salary
Salary:
115494.60 - 156257.40 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma / GED and 10 years of biologics process development or commercial-scale technology transfer and technical support experience OR Associate’s degree and 8 years of biologics process development or commercial-scale technology transfer and technical support experience OR Bachelor’s degree and 4 years of biologics process development or commercial-scale technology transfer and technical support experience OR Master’s degree and 2 years of biologics process development or commercial-scale technology transfer and technical support experience OR Doctorate degree
Job Responsibility
Job Responsibility
  • Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (downstream purification) in the development of process improvements, facility adaptations, and new process operations
  • Provide technical leadership and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing
  • Support the GMP manufacturing process tech transfer, evaluations, investigations, innovation and product life cycle management
  • Provide support for regulatory filing, inspection, and other CMC activities
  • Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations
What we offer
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
Read More
Arrow Right
New

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Drexel Hill
Salary
Salary:
Not provided
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
June 22, 2026
Flip Icon
Requirements
Requirements
  • Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
  • If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
  • If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
  • State-level licensure and national certification requirements vary by state, click here to learn more
  • Regular and predictable attendance, including nights and weekends
  • Ability to complete required training within designated timeframe
  • Attention and Focus
  • Customer Service and Team Orientation
  • Communication Skills
  • Mathematical Reasoning
Job Responsibility
Job Responsibility
  • Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
  • Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
  • Contributing to positive patient experiences by showing empathy and genuine care
  • Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team
  • Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
  • Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
  • Understanding and complying with all relevant federal, state, and local laws, regulations, professional standards, and ethical principles
  • Delivering additional patient health care services (e.g., immunizations, point-of-care testing, and voluntarily staffing offsite clinics), where allowable by law and supported by required training and certification
  • Where permissible, the Pharmacy Technician may also support immunizations, which includes the following responsibilities: Completing additional licensure and training requirements, in compliance with state Board of Pharmacy regulations, to obtain Technician Immunizer status to support preparing and administering vaccines
  • Educating patients about the importance of vaccines and referring patients to the Pharmacist-on-duty for vaccination questions
What we offer
What we offer
  • medical, dental, and vision coverage
  • paid time off
  • retirement savings options
  • wellness programs
  • and other resources, based on eligibility
  • Fulltime
Read More
Arrow Right
New

Mri Technologist

MedPro Healthcare Staffing, a Joint Commission-certified staffing agency, is see...
Location
Location
United States , Springfield
Salary
Salary:
Not provided
medprostaffing.com Logo
MedPro Healthcare Staffing
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Completion of a two year approved School of Radiologic Technology
  • Valid state radiology registration as required by state law
  • Registry by the American Registry of Radiologic Technology.
Job Responsibility
Job Responsibility
  • MRI technologists utilize their knowledge of anatomy, physiology and the principles of MRI to safely and efficiently operate MRI scanners, assisting in the diagnosis of disease and injury.
  • Ensure the safety of patients, staff and visitors who come in contact with the powerful magnetic field of a MRI scanner.
  • Position patients and coils on a table that slides inside the MRI scanner.
  • Inject contrast media as required.
  • Set appropriate technical parameters, operate MRI scanners and related equipment, and observe image data on computer monitors during scans.
  • Be familiar with the differences from a normal image and an abnormal image.
  • Recognize and respond to life threatening situations.
  • Assure compliance with federal, state, and local technical and professional regulations and accepted practiced guidelines.
  • Delivers quality, cost effective patient care in a professional manner.
  • Works effectively to maintain an environment of excellence, which is patient focused, providing timely, compassionate, quality patient care.
What we offer
What we offer
  • Weekly pay and direct deposit
  • Full coverage of all credentialing fees
  • Private housing or housing allowance
  • Group Health insurance for you and your family
  • Company-paid life and disability insurance
  • Travel reimbursement
  • 401(k) matching
  • Unlimited Referral Bonuses up to $1,000
  • Fulltime
Read More
Arrow Right
New

Pharmacy Technician

We're building a world of health around every individual — shaping a more connec...
Location
Location
United States , Oakville
Salary
Salary:
18.94 - 28.94 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
June 23, 2026
Flip Icon
Requirements
Requirements
  • Must be at least 16 years of age
  • Licensure requirements vary by state
  • Attention and Focus
  • Customer Service Orientation
  • Communication Skills
  • Mathematical Reasoning
  • Problem Resolution
  • Physical Demands
  • Visual Acuity
  • High School diploma or equivalent preferred but not required.
Job Responsibility
Job Responsibility
  • manage all assigned pharmacy workstations and tasks to support the team's ability to promptly, safely and accurately fill patient prescriptions
  • provide caring service that exceeds customer expectations
What we offer
What we offer
  • dental
  • vision
  • wellness resources
  • employee discounts
  • access to certain voluntary benefits
  • Parttime
Read More
Arrow Right
New

Cath Lab Registered Nurse

MedPro Healthcare Staffing, a Joint Commission-certified staffing agency, is see...
Location
Location
United States , Denville
Salary
Salary:
Not provided
medprostaffing.com Logo
MedPro Healthcare Staffing
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Active RN License
  • Degree from accredited nursing program
  • BLS & ACLS Certifications
  • Eighteen months of recent experience in an Acute Care Cath Lab setting
Job Responsibility
Job Responsibility
  • The Cardiac Cath Lab RN performs angioplasties, implants pacemakers and diagnoses cardiac conditions with an invasive catheterization procedure
  • Administer care for heart disease and heart attack patients by obtaining visual diagnostics of the arteries of the heart
  • Identify blockages, assisting the physician during procedures, and monitoring the patient’s status at other times
  • Administer interventional procedures like cardiac catheterizations, angioplasties, pacemaker and/or defibrillator implantation, and related interventional or diagnostic procedures
What we offer
What we offer
  • Weekly pay and direct deposit
  • Full coverage of all credentialing fees
  • Private housing or housing allowance
  • Group Health insurance for you and your family
  • Company-paid life and disability insurance
  • Travel reimbursement
  • 401(k) matching
  • Unlimited Referral Bonuses up to $1,000
Read More
Arrow Right
New

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Tipp City
Salary
Salary:
17.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
July 25, 2026
Flip Icon
Requirements
Requirements
  • Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
  • If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
  • If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
  • State-level licensure and national certification requirements vary by state, click here to learn more
  • Regular and predictable attendance, including nights and weekends
  • Ability to complete required training within designated timeframe
  • Attention and Focus: Ability to concentrate on a task over a period of time
  • Ability to pivot quickly from one task to another to meet patient and business needs
  • Ability to confirm prescription information and label accuracy, ensuring patient safety
  • Customer Service and Team Orientation: Actively look for ways to help people, and do so in a friendly manner
Job Responsibility
Job Responsibility
  • Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
  • Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
  • Contributing to positive patient experiences by showing empathy and genuine care: creating heartfelt and personalized moments while serving patients at pick-up, drive-thru, and over the phone
  • keeping patients healthy by offering immunizations and other services at the register and over the phone
  • and demonstrating compassionate care by solving or escalating patient problems
  • Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team, such as accurately putting away medication deliveries and completing cycle counts, returns-to-stocks, waiting bin inventories, etc.
  • Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
  • actively seeking opportunities to expand clinical and technical knowledge needed to better assist patients
  • Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
  • voluntarily traveling to stores in the market to work shifts as needed by the business
What we offer
What we offer
  • Dental
  • Vision
  • Wellness resources
  • Employee discounts
  • Access to certain voluntary benefits
  • Parttime
Read More
Arrow Right