Manufacturing Associate

Company: Actalent
Location: Rockville
Posted on: November 26, 2022

Job Description:

Description:

Join a small and growing Manufacturing Operations team! You will be part of our very first group of our on the floor Gene Therapy Manufacturing team who will help us to establish their 1st internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability. As a member of the highly engaged and collaborative Manufacturing Operations team, you will have the unique opportunity to start-up an agile, multi-product, single-use facility. You will be accountable for supporting the establishment of new processes, procedures and ways of working, as well as performing manufacturing process related tasks and unit operations within the Upstream and Downstream areas.

--- 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).

--- Embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.

--- Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment.

--- Partner with Quality to maintain a robust quality and compliance culture and performance that meets applicable GMP regulatory standards and supports regulatory inspections.

--- 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.

--- Review, revise and/or author a growing library of GMP documentation.

--- Proactively work to achieve training competency in an expanding manufacturing facility.

--- Perform as a qualified trainer for assigned GMP manufacturing operations, processes and equipment for US and DS areas.

--- Support root cause analysis for Manufacturing events and assist with investigations.

--- Lead projects of minor to moderate scope with the support of cross-functional stakeholders.

--- Lead continuous improvement projects within functional area.

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.

Keywords: Actalent, Rockville , Manufacturing Associate, Other , Rockville, Maryland