Pharmaceutical Operator

Initial Therapeutics, Inc.; Virginia (MN); On-site; USD 34,440 - 41,328; Full time

Job summary

Afton Scientific, a Virginia-based contract manufacturing organization (CMO), specializes in small-batch filling of injectables from clinical trials to commercial drugs. It offers sterile manufacturing, packaging and labeling, analytical and micro lab services, and Ready-To-Fill components.

The role involves performing production operations, documenting batch records, supervising contract staff, and maintaining clean room conditions in an on-site facility in Virginia.

Qualifications

• Ability to read and write in English.
• Physical ability to stand for extended periods and lift up to 50 pounds.
• Experience working in a clean room preferred.
• Ability to work with minimal supervision.
• Maintains neat and accurate records.

Responsibilities

• Perform manufacturing processes and operate production equipment per batch records and SOPs.
• Maintain documentation (batch records, production logs).
• Write and review master documents (SOPs, batch records).
• Prepare and review operation deviation reports.
• Supervise contract production staff as applicable.
• Maintain inventory of control warehouse space.
• Work in the aseptic processing area (APA) and ensure clean conditions.
• Maintain order and cleanliness in the production area.

Skills

Read and write English

Stand for long periods

Lift up to 50 pounds

Work with minimal supervision

Clean room environment

Education

High school diploma or GED

Associate or Bachelor's degree desirable

Job description

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

• Serving clients in 18 Countries
• Successful NDA and ANDA drug registrations
• In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Pay Details:

Non-exempt position, range of $25 - $30 per hour, depending on level of experience.

Essential Functions:

1. Perform manufacturing processes and operate production equipment, including, but not limited to: washers, autoclave, dry heat oven, heat sealers, vial washer, ultrasonic cleaner.
2. Perform production operations according to Batch Records and Standard Operating Procedures (SOPs)
3. Maintain proper documentation (batch records, production logs, etc.)
4. Write and review master documents as applicable: SOPs and batch records
5. Write Operation Deviation Reports
6. Supervise contract production employees as applicable
7. Maintain inventory of control warehouse space
8. Perform production and maintenance activities in the Aseptic Processing Area (APA)
9. Write and edit documents including: procedures, deviations, master batch records, protocols and reports as necessary
10. Perform initial assembly and review of completed production records for completeness
11. Maintain order and cleanliness in production area

Knowledge, Skills & Abilities

1. Ability to read and write English. Dress, speak and act in a professional manner
2. Physically able to stand for extended periods of time, mover objects up to 50 pounds, bend and reach to access equipment, have near vision correctable to 20/20 and be able to wear corrective eyewear to achieve this, if necessary.
3. Must be capable of working in close proximity to other employees, regardless of gender, in the confined environment of the production facility.
4. Must be capable of working in the clean room for uninterrupted extended periods
5. Ability to maintain neat and accurate records required
6. Must be able to work with minimal supervision.

Requirements for Education and Experience

1. Minimum of high school diploma or GED; Associates or Bachelor’s degree desirable
2. One year of manufacturing experience required. Three years manufacturing experience or more strongly preferred.
3. Clean room experience preferred.