Manufacturing Associate

Integrated Resources, Inc ( IRI ); Oceanside (CA); On-site; USD 55,000 - 75,000; Full time

Job summary

Integrated Resources, Inc (IRI) seeks a Manufacturing Technician to support our viral vector manufacturing facility in Oceanside, CA. Under minimal supervision, you will perform front-line manufacturing of viral vectors, following batch records, SOPs, and cGMP regulations to ensure safe and compliant operations.

You will work with MSAT, Facilities and Engineering, and Quality to execute GMP runs, handle raw material weighing and MES/EBS transactions, perform chromatography and

Qualifications

• Bachelor’s Degree or AA with 2+ years of biotech manufacturing experience
• High School diploma with 3+ years of biotech manufacturing experience

Responsibilities

• Execute manufacturing processes on the floor under supervision following batch records, SOPs, and cGMP regulations.
• Ensure right-the-first-time performance of process steps and support a safety-first culture.
• Collaborate with MSAT, Facilities and Engineering, and Quality to run GMP operations.
• Weigh raw materials and perform MES and EBS inventory transactions.
• Perform chromatography and ultrafiltration/diafiltration for viral vector production using aseptic technique.
• Prepare and use single-use systems for buffer prep and filter integrity testing.
• Assist with fill of harvested viral vector material.
• Escalate processing and equipment issues; assist revisions of SOPs and MPRs; review in-process cGMP docs.
• Work effectively in cross-functional team; willingness to work off-shift and weekends.

Skills

Batch records compliance

SOP adherence

cGMP knowledge

Team collaboration

Safety-focused

Data analysis (Excel)

Aseptic technique

Lift 40 lbs

Education

Bachelor’s Degree in Biology or related field

AA Degree with biotech manufacturing experience

High School diploma with biotech manufacturing experience

Tools

MES (Manufacturing Execution Systems)

EBS (Enterprise Business System)

Microsoft Word

Microsoft Excel

Job description

We are seeking a highly motivated Manufacturing Technician to support our Viral Vector manufacturing facility in Oceanside, CA. Under minimal supervision, in this role you will be accountable for and focused on front line manufacturing of viral vectors.

Responsibilities (including, but are not limited to):

• Execute manufacturing processes on the floor under supervision, while rigorously following batch records, standard operating procedures (SOPs), and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
• Ensure right-the-first-time performance of all process steps specific to the step of operation, as well as help drive the safety-first culture at client Oceanside.
• Work as part of a team to execute Good Manufacturing Practice (GMP) runs in close collaboration with, Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
• Under supervision, perform weighing of raw materials, as well as electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS).
• Under supervision, perform Chromatography and Ultrafiltration/Diafiltration operations for the manufacturing of viral vector products in a cGMP environment using proper aseptic technique, proper cleanroom etiquette, Good Documentation Practices (GDP), and sound scientific methods.
• Prepare and use single use systems to support buffer preparation and filter integrity testing.
• Assist with manual and/or automated fill of harvested viral vector material.
• Escalate processing and equipment issues as needed.
• Assist with revisions of SOPs, Manufacturing Production Record (MPRs), and other controlled documents.
• Assist in the review of in-process cGMP documentation for completeness, accuracy, and compliance.
• Ability to work effectively in an inclusive, cross-functional, team-based environment.
• Able to work off shift hours and weekend.
• Additional duties as assigned.

Basic Qualifications:

• Bachelor’s Degree Or
• AA Degree with 2+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry Or
• High School diploma with 3+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry

Preferred Qualifications:

• 0+ years of experience with Bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education
• Prior experience with biopharmaceutical, cell or gene therapy manufacturing is a plus
• Knowledge of the Current Good Manufacturing Practices (cGMP's) desired
• Excellent skills in Microsoft Word, Excel and data analysis
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal, verbal and written communication skills
• Willingness to think outside of the box as well as comfortable in a fast-paced and constantly evolving environment
• Ability to lift 40 lbs repeatedly and stand for hours at time
• Able to work off shift hours and weekend