MANUFACTURING TECH- DOWNSTREAM

Spherion; College Station (TX); In loco; USD 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical

Prescription

Dental

Vision

AD&D

Life insurance offerings

Short-term disability

401K plan

Descrizione del lavoro

Spherion Staffing, LLC is seeking a Manufacturing Downstream Lead to prioritize daily schedule requirements and execute manufacturing operations in a fast-paced cGMP cleanroom.

The role leads downstream processing activities, mentors junior staff, and supports CAPAs, qualification/validation work, ensuring audit-ready cleanrooms and organized work areas.

Competenze

• BS/BA in biotech, biology, or chemistry with 3–4 years manufacturing experience.
• High school diploma with 4–5 years relevant manufacturing experience.
• Advanced cGMP, cleanroom operations and aseptic practices.
• Downstream processing experience including chromatography and TFF.
• Strong writing and documentation skills for deviations, logbooks and SOPs.

Mansioni

• Execute downstream and cleanroom operations per cGMP.
• Perform purification using TFF and Chromatography.
• Manage filtration, product transfers, aseptic sampling and cell expansion.
• Lead operations inside the cleanroom and coordinate QC handovers.

Conoscenze

cGMP Biopharma

Gene/Viral therapy

Regulatory knowledge

5S & Lean

Bioprocessing

Leadership

Formazione

Bachelor's degree in Biotechnology/Biology/Chemistry

Descrizione del lavoro

The Manufacturing Downstream Lead (Associate III-IV) is responsible for prioritizing daily schedule requirements and executing manufacturing operations within a fast-paced cGMP cleanroom environment. Serving as the main operational point of contact inside the cleanroom, this role leads core downstream processing activities-including chromatography, tangential flow filtration (TFF), filtration techniques, and product filling. The position is also instrumental in mentoring junior personnel, supporting root cause investigations and CAPAs, assisting with qualification/validation work, and ensuring cleanrooms remain organized, stocked, and audit-ready at all times.

Responsibilities

Execute daily downstream and cleanroom manufacturing operations in compliance with cGMP standards. Perform and oversee purification techniques including Tangential Flow Filtration (TFF) and Chromatography. Execute normal flow and depth filtration, product transfers, aseptic sampling, cell expansion, and bioreactor operations. Perform manual, semi-automated, or automated product filling within aseptic environments, biological safety cabinets (BSCs), or isolators. Serve as the primary lead and operational point of contact inside the cleanroom. Coordinate product-related sample transfers and manage handovers to the Quality Control (QC) department.

Working hours

8:00 AM - 5:00 PM

Skills

Prior experience in a regulated cGMP biopharmaceutical or biologics manufacturing facility. Experience with Gene/Viral therapy products focusing on bioprocessing operations. Advanced knowledge of FDA and EMA regulatory requirements applicable to biologics. Familiarity with 5S methodology, lean manufacturing principles, and process optimization projects. Prior upstream processing experience (bioreactor operations, cell expansion) alongside downstream purification. Demonstrated leadership, diplomacy, collaborative teamwork, and project support capabilities.

Education

Bachelors

Experience

1-4 years

Qualifications

Education & Experience: Associate or Bachelor of Science degree in Biotechnology, Biology, Chemistry, or a related discipline with a minimum of 3???4 years of manufacturing experience; OR High School Diploma (or equivalent) with a minimum of 4???5 years of relevant manufacturing experience.

Technical Knowledge: Advanced understanding and practical application of cGMP principles, cleanroom operations, and aseptic practices. Advanced operational and troubleshooting expertise in downstream processing (Chromatography, TFF, filtration techniques, aseptic filling). Experience operating within biological safety cabinets (BSCs) or barrier isolators.

Documentation & Investigation: Strong technical writing skills to initiate deviations, complete logbooks, and generate/update SOPs and batch documentation. Proven logic, critical thinking, and decision-making capabilities to assist with troubleshooting and root cause analysis.

Physical Demands & Work Schedule Flexibility: Ability to lift up to 50 lbs. Ability to meet physical demands including standing, walking, sitting, bending, and fine motor manipulations in cleanroom attire. Comfort with spending extended periods gowning in cleanroom environments (55%???65% of the day). Flexibility to work varying schedules, including 8, 10, or 12-hour shifts across days, nights, weekends, and holidays. Willingness to travel (<10%) if needed.

key responsibilities

Execute daily downstream and cleanroom manufacturing operations in compliance with cGMP standards. Perform and oversee purification techniques including Tangential Flow Filtration (TFF) and Chromatography. Execute normal flow and depth filtration, product transfers, aseptic sampling, cell expansion, and bioreactor operations. Perform manual, semi-automated, or automated product filling within aseptic environments, biological safety cabinets (BSCs), or isolators. Serve as the primary lead and operational point of contact inside the cleanroom. Coordinate product-related sample transfers and manage handovers to the Quality Control (QC) department.

experience

1-4 years

skills

Prior experience in a regulated cGMP biopharmaceutical or biologics manufacturing facility. Experience with Gene/Viral therapy products focusing on bioprocessing operations. Advanced knowledge of FDA and EMA regulatory requirements applicable to biologics. Familiarity with 5S methodology, lean manufacturing principles, and process optimization projects. Prior upstream processing experience (bioreactor operations, cell expansion) alongside downstream purification. Demonstrated leadership, diplomacy, collaborative teamwork, and project support capabilities.

qualifications

Education & Experience: Associate or Bachelor of Science degree in Biotechnology, Biology, Chemistry, or a related discipline with a minimum of 3???4 years of manufacturing experience; OR High School Diploma (or equivalent) with a minimum of 4???5 years of relevant manufacturing experience.

Technical Knowledge: Advanced understanding and practical application of cGMP principles, cleanroom operations, and aseptic practices. Advanced operational and troubleshooting expertise in downstream processing (Chromatography, TFF, filtration techniques, aseptic filling). Experience operating within biological safety cabinets (BSCs) or barrier isolators.

Documentation & Investigation: Strong technical writing skills to initiate deviations, complete logbooks, and generate/update SOPs and batch documentation. Proven logic, critical thinking, and decision-making capabilities to assist with troubleshooting and root cause analysis.

Physical Demands & Work Schedule Flexibility: Ability to lift up to 50 lbs. Ability to meet physical demands including standing, walking, sitting, bending, and fine motor manipulations in cleanroom attire. Comfort with spending extended periods gowning in cleanroom environments (55%???65% of the day). Flexibility to work varying schedules, including 8, 10, or 12-hour shifts across days, nights, weekends, and holidays. Willingness to travel (<10%) if needed.

education

Bachelors

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Spherion offers a comprehensive benefits package, including:

• medical
• prescription
• dental
• vision
• AD&D
• life insurance offerings
• short-term disability
• a 401K plan

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].