Downstream Manufacturing Associate I/III (CO)
Downstream Manufacturing Associate I/III (CO)
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Job Description
Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
SUMMARY:
The role of the Manufacturing Associate is to act as a controller providing essential duties to support the respective production suite Supervisor and Manager. On a daily basis the Manufacturing Associate is expected to have a full understanding of the schedule and required tasks; promoting adequate assessment and response of any production demands.
PRINCIPAL RESPONSIBILITIES:
- Responsible for adherence to all Standard Operating Procedures (SOPs) Master Production Records (MPRs) protocols policies regulatory requirements good manufacturing practices (GMPs) and safety guidelines.
- Participates in and/or leads unit operations described in standard operating procedures manufacturing batch records and cGMP guidelines.
- Proactively works with all team members subject matter experts and management to achieve training competency in production operations.
- Setup maintenances and use of cGMP equipment as directed by standard operating procedures and manufacturing batch records.
- Ensure compliance with company quality systems safety procedures and other company policies.
- Participate and support a culture of continuous improvement. Effectively collaborates with cross functional partners such as Quality Assurance Quality Control Supply Chain and Facilities
- Reviews executed batch production records to ensure compliance with approved procedures and GMP expectations.
- Operate analytical equipment including analytical scale pH meter spectrophotometer filter integrity tester etc
- Mix store and dispose of chemical solutions (may include hazardous material).
- Works in a cleanroom environment performing aseptic processing while maintaining manufacturing environmental conditions.
KNOWLEDGE SKILLS & ABILITIES:
- Solid interpersonal and teamwork skills able to work crossfunctionally and collaborate with various levels.
- Ability to work in a cleanroom environment for extended periods of time.
- Flexible have the availability to work hours necessary to support production and / or maintenance activities.
- Ability to lift up to 50 lbs. with assistance push pull bend and stand for prolonged periods of time.
- Willingness to learn and advance within the company and/or department.
EDUCATION/EXPERIENCE:
- High school diploma or equivalent required.
- Bachelors degree or Biotech certificate quality systems regulations (cGMP) knowledge and clean room experience preferred but not required.
- Minimum 1 year of experience working within a federally regulated industry to be considered for a level greater than an Associate I
- For consideration for a Senior level associate must be proficient with the following systems Viral Segregation (Viral Inactivation/Viral Filtration) AKTA Operations Ultrafiltration and Diafiltration operations and Bulk Filling Operations.
- A preemployment lift test and physical may be required for some positions within Manufacturing.
COMPENSATION RANGE:
Level I $23.31$32.05
Level II $28.73$39.50
Level III $36.04$49.55
At AGC Biologics we are always seeking dedicated and skilled Manufacturing Associates to join our team. By maintaining this evergreen job posting we can connect with potential candidates as new opportunities arise within our team. We actively monitor applications and continuously match candidates to available positions ensuring that we find the right fit for both you and our organization.
Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Required Experience:
IC
Employment Type
Full-Time
