Job Title: Downstream Manufacturing Associate
Job 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.

ResponsibilitiesEmbody 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 SkillsGMP quality systems and/or manufacturing operations, processes, and equipment for DownstreamExperience with AAV manufacturing/viral transfectionExperience in supporting facility start-up, commissioning, and qualification activitiesHands-on experience with single-use technologies and systemsGood oral and written communication skillsGood teaching and facilitation skills for on-the-job training deliveryExperience using relevant systemsDemonstration of a high level of performanceAdditional Skills & QualificationsBachelor’s degree OR Associate’s degree/High School Diploma OR equivalent with relevant cGMP experience1.5-3 years of cGMP experience in biologics, pharmaceutical, and/or vaccine manufacturing operations, ideally in downstream purificationAbility to work collaboratively with colleagues in a results-driven, team-oriented environmentWork 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

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

� 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 20, 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 for other accommodation options.