Scientist - Microbiology

Celltrion Branchburg; Branchburg Township (NJ); Híbrido; USD 71.000 - 116.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO

Holidays

Medical insurance

Dental insurance

Vision insurance

Life insurance

Retirement plan

Wellness programs

Disability benefits

Descripción de la vacante

Celltrion Branchburg, LLC seeks a QC Microbiology professional to perform routine testing and support investigations in a regulated environment. You will generate and revise technical documents, train staff, and assist in special microbiological projects while applying cGMP and ALCOA principles.

You will conduct testing on water, in-process materials, final products, and environmental samples; identify organisms; and ensure equipment calibration, document control, and trend reporting.

Formación

• Experience in routine QC microbiology testing in regulated environments.
• Ability to prepare and revise SOPs, protocols and trend reports.
• Capable of training new or existing staff on procedures.
• Strong technical writing and problem-solving skills.
• Familiarity with cGMP and ALCOA principles.

Responsabilidades

• Perform routine QC microbiology testing on water, in-process materials, and products.
• Identify organisms and conduct Bioburden, Endotoxin, Sterility, and related tests.
• Maintain microbial stock culture and assist in special projects/ validations.
• Create, revise, or review documents such as SOPs and deviation investigations.
• Train analysts and ensure calibration/maintenance of lab equipment.

Conocimientos

Teamwork / communication

Attention to detail

Independent work

MS Office proficiency

Flexibility for weekends/overtime/hols

MODA / LIMS / SmartLab / TrackWise

cGMP knowledge

Educación

AS degree with 2+ years experience

BS/MS with 0+ years experience

Herramientas

MODA

LIMS

SmartLab

TrackWise

Descripción del empleo

This position relies on experience and knowledge in the field of Microbiology to perform work in a compliant manner. Conducts routine of microbiological samples. Perform non-routine analyses as assigned by supervisor as needed. creates and/or revising technical documents, creating and/or leading special microbiological projects, and training new/existing employees on procedures and job functions. Uses scientific expertise to provide assistance to coworkers for troubleshooting, laboratory investigations and problems resolution. Suggests process improvements to QC management. Maintains familiarity in a variety of microbiological concepts, practices, and procedures. Performs routine QC responsibilities as needed. Applies acceptable cGMP practices and ALCOA principles during execution of all work tasks. Presents innovative and creative solutions to problems. Exhibits good problem solving and technical writing skills. Updates supervisor of progress on a regular basis.

Manage for Results /Strategic Planning:

1. Performs the following routine QC Microbiology responsibilities as it relates to the specific area and is assigned by supervisor:

a. Perform routine microbiological testing on water, gas, in-process materials, final products, raw materials, environmental/water samples, finished goods

b. Performs material qualifications and QC inventory control.

c. Performs identification of organisms.

d. Performs Bioburden, Endotoxin, Sterility, Microbial Identification, and biological indicator testing.

e. Prepares and maintains microbial stock culture.

g. Assists in special projects (i.e. validations, microbiological studies, etc).

2. Creates, revises, or reviews documents such as:

a. SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, or

invalid assays).

b. Performs analytical and deviations investigations

c. Reviews microbiology testing data and logbooks.

3. Train other analysts on procedures, as needed.

4. Ensuring that laboratory equipment is maintained and within calibration

Basic Requirements:

• Excellent teamwork and communication skills.
• Great attention to detail.
• Ability to work independently and achieve problem resolution with minimal supervision.
• Competent in use of Microsoft Office programs. Flexibility to work weekends, overtime, and holidays as needed.
• Comfortable with computerized data storage systems (i.e. MODA, LIMS, SmartLab, TrackWise, etc).
• Good working knowledge of cGMP regulations.

Education Requirements:

• A.S with 2+ years industry experience in a related science such as Biology, Biochemistry or other science discipline
• B.S or M.S with 0 + years industry experience in a related science such as Biology, Biochemistry or other science discipline.

This role is exempt and the anticipated compensation for this role is $71,250 - $116,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

• Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave)
• medical
• dental
• vision insurance
• life insurance
• a company-matched retirement savings plan
• wellness programs
• short- and long-term disability benefits.

This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.