Biopharm Manufacturing Associate - Level 2

1 Year (potential for extension)

King of Prussia, Pennsylvania

Shift: Must to be open all shifts

• Training “Boot Camp” 4 weeks M-F (7:30am – 4:00pm EST)
• 12-hour shifts from (5:00pm to 5:00am OR 5:00am to 5:00pm EST).
• It also includes every other weekend and Holidays.
• 3- or 4-day week with rotating schedule.

Required:

• BS/BA degree, with cGMP manufacturing experience.

• OR an Associate’s degree from Montgomery county community college in Biotechnology or related technical field with cGMP manufacturing experience.

• OR High School degree, 1+ years of cGMP manufacturing experience.

Preferred Qualifications:

• Demonstrated level of high performance.
• Strong verbal and written skills.
• The ability to work well in a team environment.
• Must be able to follow detailed processing instructions as well as accurately document all necessary documentation.

Job Description

As a Biopharm Manufacturing Associate II, you will perform production operations including fermentation or cell culture operations, preparation of solutions, chromatographic separation, filtration and concentration operations, autoclave and parts washing of process assemblies, and area cleaning/upkeep. Will be responsible for completing daily manufacturing tasks and increasing competency in different production areas over time. Will participate in safety and compliance initiatives, as well as investigations.

Will engage in the Production System to continuously improve safety, quality, and schedule/cost performance. The purpose of this role is to be a part of a dynamic, multi-tiered operations team that brings life changing and lifesaving medicine to patients around the world. They will demonstrate Values (Patient Focus, Transparency, Respect, & Integrity) and Expectations (Courage, Accountability, Development, & Teamwork) daily by engaging positively with team members and production support groups. Under the direction of senior personnel, the biopharmaceutical manufacturing associate II performs a

variety of largescale production operations, interacting with automated equipment and

monitoring/processing data. Will be responsible for completing daily manufacturing tasks and increasing competency in different production areas over time. They will participate in safety and compliance initiatives, investigations, and help solve technical and organizational problems while working with different teams of experts. Will work within these teams to continuously improve safety, quality, and schedule/cost performance.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.

Job Responsibilities

• Demonstrate company Values – Patient Focus, Transparency, Respect, and Integrity – in every interaction, in every work task, and with every responsibility of the job role.
• Live company’s Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace.
• With good documentation and data integrity practices, safely and compliantly completes and documents daily manufacturing tasks per standard operating procedures, batch document instructions, and logbooks.
• Proactively work with senior staff to achieve competency in production operations.
• Supports in cross-functional activities, such as engineering actions, validation actions and Tech Transfer actions, including proactive safety and compliance input prior to execution.
• Primarily these activities are within the production suite but sometimes require out-of-suite or off-site work (i.e. FAT support).
• Monitors equipment and critical process parameters and escalate any issues or abnormalities and participating in the resulting troubleshooting activities.
• Strives to maintain a high level of competency with current and emerging digital platforms (SAP, EBR, AR/VR, etc).
• By learning the production schedule and assessing it daily, proactively ensures all processing equipment and necessary materials are adequate and available to set the team up for success.
• Transparently participates in investigations that are the result of safety or compliance issues.

Education & Qualifications

• BS/BA degree, with cGMP manufacturing experience.

• OR an Associate’s degree from Montgomery county community college in Biotechnology or related technical field with cGMP manufacturing experience.

• OR High School degree, 1+ years of cGMP manufacturing experience.

• Open to any other scientific background education or experience.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Demonstrated level of high performance.
• Strong verbal and written skills.
• The ability to work well in a team environment.
• Must be able to follow detailed processing instructions as well as accurately document all necessary documentation.