Manufacturing Associate I

Use Your Power for Purpose

Our breakthroughs rely on the expertise of our dedicated pharmaceutical manufacturing team to reach those in need. Your role here will be critical, as you leverage your skills and knowledge to ensure that essential medicines are produced efficiently and delivered promptly. By embracing agility and commitment, your contributions will significantly improve patient outcomes and reinforce the profound impact of our collective efforts. Together, we ensure that both patients and physicians have timely access to necessary medicines.

Position Summary

As part of the Downstream Manufacturing team, the Manufacturing Associate I completes production activities related to downstream purification of mAb drug intermediate and drug product in a cGMP environment in coordination with other associates and under supervision of the Manufacturing Supervisor.

Principal Responsibilities

• Performs downstream operations safely and compliantly in accordance with OSHA and cGMP guidelines. Downstream operations include but are not limited to; dispensing and sampling of raw materials, buffer preparation, column packing, UF/DF, chromatography, viral inactivation and filtration, product sampling, and filling of bulk drug product or intermediate.

• Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.

• Performs oversight of process operations and monitors equipment and critical process parameters. Escalates any issues or abnormalities to management and shift leads, senior associates and/or system matter experts. Participates in resulting troubleshooting activities as necessary.

• Completes setup, use and cleaning (as necessary) of cGMP production equipment.

• Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate.

• Proactively works with senior associates, system matter experts, and management to achieve training competency in production operations.

• Maintains a clean and orderly production area. Positively engages and collaborates with other team members to ensure daily production tasks are completed in a timely manner.

• Participates in investigations of safety or quality issues as necessary.

• Participates and supports a culture of continuous improvement. Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities.

Here Is What You Need (Minimum Requirements)

• High School Diploma / Associates Degree with exposure to science & math coursework

• 0-2 years of cGMP experience

• Ability to follow detailed instructions and to maintain accurate records and notes

• Ability to work effectively in a team environment

• Excellent oral and written communication skills

• Ability to work occasional weekends, holidays or overtime as needed

• Ability to lift up to 20 Kg

• Familiarity with MS Office applications (Word, Excel)

Competencies

• Action Oriented

• Collaborates

• Communicates Effectively

• Decision Quality

• Interperso