Job Description

Description:

Opportunity to work in an "ALL" stream environment that allows for cross-functional development between the differing manufacturing areas, i.e. media/buffer prep, upstream (US), and downstream (DS) and fill finish(FF) \xe2\x80\xa2 Embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives. \xe2\x80\xa2 Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment. \xe2\x80\xa2 Partner with Quality to maintain a robust quality and compliance culture and performance that meets applicable GMP regulatory standards and supports regulatory inspections. \xe2\x80\xa2 Execute and support operational readiness activities for the NEW internal manufacturing facility, including the establishment of manufacturing procedures and standard practices, facility start-up, commissioning, and qualification of equipment and automation. \xe2\x80\xa2 Review, revise and/or author a growing library of GMP documentation. \xe2\x80\xa2 Proactively work to achieve training competency in an expanding manufacturing facility. \xe2\x80\xa2 Perform as a qualified trainer for assigned GMP manufacturing operations, processes and equipment for US and DS areas. \xe2\x80\xa2 Support root cause analysis for Manufacturing events and assist with investigations. \xe2\x80\xa2 Lead projects of minor to moderate scope with the support of cross-functional stakeholders. \xe2\x80\xa2 Lead continuous improvement projects within functional area. Interview process: Phone screen/zoom with Steve and Joe then 2nd round with Katie.

Skills:

GMP, Manufacturing, Cleanroom, Aseptic, media, buffer prep, Media prep, upstream, downstream, vaccine, cell culture, purification, Batch Record, Gene Therapy, biologics, fill finish, AAV

Top Skills Details:

GMP,Manufacturing,Cleanroom,Aseptic,media,buffer prep,Media prep

Additional Skills & Qualifications:

1. Describe in just a few sentences the day-to-day activity of the role: o Assembly creation, autoclaving, cleaning equipment and materials o Support Upstream and downstream BDS manufacturing processes; BSC aseptic operations, setting up equipment for process, making media, editing SOPs. Working with cell culture, recovery, purification, bulk formulation and fill finish. 2. What education/experience is required? o Bachelor\'s degree OR Associate\'s degree/High School Diploma OR equivalent with relevant cGMP experience. o 1.5-3 years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and fill finish. 3. What skills are required? Good oral and written communication skills. Good teaching and facilitation skills for on-the-job training delivery. Experience in GMP quality systems and/or manufacturing operations, processes and equipment for US, DS, and/or FF areas. Experience with AAV manufacturing/viral transfection. Experience in supporting facility start-up, commissioning, and qualification activities. Hands on experience with single-use technologies and systems. Experience using PCS system. Demonstration of a high level of performance. 4. Preferred Qualifications: Strong subject matter expertise in GMP Manufacturing operations, processes and equipment for large scale GMP manufacturing Experience with AAV manufacturing/viral transfection. Experience in supporting facility start-up, commissioning, and qualification activities. Hands on experience with single-use technologies and systems. Experience using PCS system. Demonstration of a high level of performance.

Experience Level:

Entry Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We\'re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Actalent