Downstream Manufacturing Lead

Responsible for prioritizing manufacturing schedule requirements and executing the daily manufacturing schedule communicated by the Manufacturing Manager within a fast-paced manufacturing operation with primary activities including but not limited to Purification Techniques (TFF and Chromatography), Various Filtration Techniques, and Product Filling.

Lead operations and act as the main point of contact within the cleanroom.

Coordinate the transfer of all products related samples and assure the proper handover of samples to Quality control department.

Read and understand technical documentation and execute written instruction.

Possess an advanced understanding and ability to put into practice cGMP principles.

Possess advanced operational skills, troubleshooting skills and process advanced knowledge within an aseptic environment, biological safety cabinet or isolator to execute such processes as Filling, filtration, product transfer, product sampling, chromatography, and TFF (Tangential flow filtration).

Possess the ability to train junior level manufacturing associates.

Support in completion of root cause investigations and CAPA implementation.

Get Involved in Equipment and instruments Qualification and Validation activities.

Plan, organize and maintain material inventory for manufacturing processes.

Clearly communicate problems and observations with manufacturing management and management from other departments.

Execute daily production operations within a cleanroom environment. The activities will include but are not limited to Cell Expansion in an aseptic environment, Bioreactor Operations, Depth Filtration, Purification through TFF (Tangential Flow Filtration), Chromatography and Various Filtration Techniques, and Product Filling via manual, semi-automated or automated filling.

Ensure clean rooms are cleaned, organized, maintained and audit ready at all times. Maintain department inventory and ensure all materials are kitted for upcoming cleanroom operations.

Maintain individual training plan and ensure your training profile remains up to date with training readiness at all times in addition to train junior level manufacturing associates.

Attending meetings, sending/receiving emails, participating in continuous improvement projects. When necessary, demonstrate strong technical writing abilities (Deviation initiations, work orders requests, Sops, Logbooks, Working Instructions, Forms creation, etc.).

Working hours:

8:00 AM - 5:00 PM

Preferred area of study:
Science related discipline.

High School Diploma or Equivalent may be considered with relevant experience.

GMP setting preferred, previous upstream and/or downstream experience preferred.

Computer software skills, organization, 5S, record keeping and planning skills, multiple projects support/lead, time management, and basis lean skills is preferred.

Bachelors

1-4 years

AS/BS in Biotechnology, Biology, Chemistry, or equivalent

Preferred area of study:
Science related discipline

Min. 3-4 years of experience in manufacturing (Min. 4-5 years of experience without AS/BS)

• Proven logic and decision-making abilities, critical thinking skills.

Aseptic practices and clean room operations:

• Advanced knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Bioprocessing Operations.
• Advanced knowledge of the manufacturing process and possesses the understanding of or ability to use the latest technologies.

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. In addition, 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.

Execute daily production operations within a cleanroom environment. The activities will include but are not limited to Cell Expansion in an aseptic environment, Bioreactor Operations, Depth Filtration, Purification through TFF (Tangential Flow Filtration), Chromatography and Various Filtration Techniques, and Product Filling via manual, semi-automated or automated filling.

Ensure…