Highland Career Network

Responsible for hands on execution of all activities related to the production of Vascugel™ for clinical use. All operations are performed under the direction of the Manufacturing Director/Manager. All duties performed in compliance with Good Manufacturing Practices (cGMPs), the Pervasis Quality Manual, and established Standard Operating Procedures (SOPs).

 

Responsibilities:

- Follow batch production records (BPRs) and SOP’s in the expansion, feeding, and passaging of cells; aseptic processing of Vascugel product units; and packaging of final product.

- Follow BPRs and SOPs to manufacture drug products in accordance with cGMP.

- Record all pertinent operations in production batch records, log books, and/or controlled documents.

- Orders, receives, and distributes supplies within the production area.

- Trends production statistics to ensure that process yields are consistent.

- Assist in the preparation of reports and GMP documentation as they apply to the scope of operations in the manufacturing facility.

Requirements :

• Associates degree in a scientific discipline or equivalent relevant education and work experience

• 1 -3 years relevant work experience.

• Ability to perform general mathematical calculations.

• Ability to concisely follow directions and document processes performed.

• Good interpersonal skills and the ability to work effectively and efficiently in a team environment.

• Good oral and written communications.

• Must be able to work in a clean room environment wearing special garments.

• Requires immunization before performing work within the manufacturing area.

• Overtime and weekend work may be required periodically.

 

Preferred:

- BS degree in a scientific discipline or the equivalent education and relative work experience.

- Knowledge of current Good Manufacturing Practices (cGMPs).

- Familiarity with aseptic techniques and standard laboratory practices.

- Familiarity with cell culture techniques.

- Experience working in a biological laboratory.

- Familiarity with good documentation practices.