Downstream Manufacturing Associate I - 3rd Shift, Biopharma

System One; Pennington (NJ); Sur place; USD 30 000 - 34 000; Plein temps

Résumé du poste

System One is hiring a Manufacturing Associate I for downstream processing in a cGMP cleanroom in Pennnington, NJ. This 3rd-shift, onsite role supports purification, buffer prep, chromatography, filtration, and aseptic activities with a focus on precise documentation.

Candidates may have a Bachelor's in a life sciences field or substantial related experience. The role emphasizes adherence to SOPs, batch records, and GMP compliance, with potential contract-to-hire outcomes.

Qualifications

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline.
• 0-2 years of relevant biopharmaceutical manufacturing experience.
• Basic understanding of biologics purification and downstream processing.
• Ability to follow detailed manufacturing procedures.
• Strong attention to detail and documentation practices.
• Knowledge of cGMP requirements is preferred.

Responsabilités

• Support day-to-day downstream manufacturing operations in a cGMP cleanroom environment.
• Prepare buffers and process solutions according to approved procedures.
• Support chromatography operations including column packing and system setup.
• Perform filtration operations including TFF and sterile filtration.
• Complete batch records, logbooks, and GMP documentation accurately.
• Follow SOPs and report deviations to supervision.
• Assist with training, audits and process improvement initiatives.
• Support manufacturing readiness activities and inspections.

Connaissances

Attention to detail

Documentation practices

Communication skills

Teamwork

cGMP knowledge

Biopharma process understanding

Formation

Bachelor's degree in Biotechnology/ Biochemistry/ Chemical Engineering/ Life Sciences

High School Diploma/GED with 4+ years biopharma experience

Outils

Chromatography systems

Tangential Flow Filtration (TFF)

AKTA chromatography platforms

Single-use technologies

Aseptic processing

Buffer preparation

Description du poste

System One is hiring a Manufacturing Associate I for downstream processing in a cGMP cleanroom in Pennnington, NJ. This 3rd-shift, onsite role supports purification, buffer prep, chromatography, filtration, and aseptic activities with a focus on precise documentation.

Candidates may have a Bachelor's in a life sciences field or substantial related experience. The role emphasizes adherence to SOPs, batch records, and GMP compliance, with potential contract-to-hire outcomes.