Manufacturing Associate II (Bio) -1+ yr. experience (contract - temp to perm)

Randstad USA; North Carolina; On-site; USD 42,000 - 66,000; Full time

Job summary

Randstad USA is seeking a Manufacturing Associate II located at RTP to perform downstream and upstream processing steps in a cGMP biomanufacturing setting onsite. The role involves operating equipment, preparing media and reagents, and supporting documentation for batch records and equipment logs.

The position offers opportunities to learn and grow, with a shift option (6-6) on day and night cycles and a supportive coaching environment to guide your career progress.

Qualifications

• Associate’s Degree with 6 months of experience.
• High School Diploma plus Biowork certification and 1 year of experience.
• Strong communication skills (verbal and written) and ability to work as a part of a team.
• Ability to lift and/or move up to 25 pounds and occasionally up to 50 pounds.
• Capable of working twelve (12) hour shifts (day and night).

Responsibilities

• Execute daily manufacturing activities, including operating process equipment and following cGMP SOPs.
• Document and record cGMP data and deviations; create batch records, SLRs, and equipment logs.
• Assist in in-process sampling and analysis (pH, Conductivity, Protein Concentration, Osmolarity, Cell Counts).
• Maintain a clean and safe work environment and contribute energy and focus as a team member.

Skills

Teamwork

Communication

Adaptability

Positive attitude

Strong work ethic

Education

Associate’s Degree

Biowork certification

High School Diploma

Job description

The Manufacturing Associate II will perform processing steps within the Upstream and Downstream processes of cGMP manufacturing activities onsite at a well respected Biomanufacturing Company located in Research Triangle Park (RTP).

This is an opportunity to be part of a team where you can learn, grow your skillset, AND have the support you need with a career coach guiding you towards success :)

Oppurtunites working the Night or Day Shift:

6-6 working a 2-2-3 shift with differential pay nights and weekends

Needed for success:

• Amazing work ethic that shines

• High adaptability and willingness to tackle whatever comes your way

• Positive and motivated attitude

Downstream / Purification:

• Buffer Preparation

• Column Chromatography

• Viral Filtration

• Ultra-Filtration

• Bulk Dispensing of the drug substance

• Purification

Upstream / Cell Culture:

• Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors

• Performing thaws and splits utilizing Aseptic technique

• Dispensing raw materials + batching of media & solutions

• Isolation

• Cell Culture

• Harvesting

• Media Preparation

What You’ll Do:

• Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)

• Document and record all cGMP data & information (including deviations) for processing steps and equipment activities. Create and revise key documentation like batch records, SLRs, and equipment logbooks

• Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, Cell Counts, etc.)

• Help maintain a clean and safe work environmentBe a team player and always showing up to contribute your energy and focus

Qualifications:

• Associate’s Degree with 6 months of experience

• High School Diploma (or equivalent) plus the Biowork certification & 1 year of experience

• Strong communication skills (both verbal and written) and ability to work as a part of a team

• Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds

• Capable of working twelve (12) hour shifts (we operate both day and night shifts)