Job Title: Downstream Manufacturing AssociateJob 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). The current need is on the downstream team. Responsibilities + 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. + Apply company policies and procedures to identify, escalate, and/or resolve routine production issues. + Support upstream and downstream BDS manufacturing processes; BSC aseptic operations, setting up equipment for process, making media, and editing SOPs. + Work with cell culture, recovery, purification, bulk formulation, and fill finish. Essential Skills + GMP quality systems and/or manufacturing operations, processes, and equipment for Downstream + 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 + Good oral and written communication skills + Good teaching and facilitation skills for on-the-job training delivery + Experience using relevant systems + Demonstration of a high level of performance Additional Skills & Qualifications + Bachelor’s degree OR Associate’s degree/High School Diploma OR equivalent with relevant cGMP experience + 1.5-3 years of cGMP experience in biologics, pharmaceutical, and/or vaccine manufacturing operations, ideally in downstream purification + Ability to work collaboratively with colleagues in a results-driven, team-oriented environment Work Environment This role operates within both an office and GMP environment. The work involves activities such as assembly creation, autoclaving, cleaning equipment and materials, and supporting manufacturing processes. The physical requirements include the ability to lift up to 50 lbs and stand in place for at least 4 hours at a time. Normal near visual acuity and no impairment of color vision are also necessary. Pay and Benefits The pay range for this position is $30.00 - $35.00 • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in ROCKVILLE,MD. Application Deadline This position will be accepting applications until Dec 17, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.