Easter Seals Jobs

Job Title: Quality Control AnalystJob Description

We are seeking a Quality Control Analyst to support the manufacture of AAV Viral Vector Gene Therapy Drug Products. This role involves performing chemistry-based testing and working within a small, cross-trained group. The primary focus will be on daily testing in the chemistry lab, ordering reagents, managing inventory, and maintaining quality records. This position requires experience in a GMP environment.

Responsibilities

• Perform Analytical/Bioanalytical testing of starting materials, in-process/finished drug products, and stability samples.

• Utilize techniques such as cell-based assays, qPCR/ddPCR, HPLC (size exclusion, reversed-phase, ion-exchange), capillary electrophoresis, light scattering, spectrophotometry, product and residual content assays, and compendial methods.

• Conduct product characterization assays to support product development and PPQ campaigns.

• Support method qualification, validation, and transfer to QC laboratories as needed.

• Order reagents, manage inventory, and maintain accurate quality records.

Essential Skills

• B.S. or A.S. in a Life Sciences discipline with at least 3-4 years of relevant experience in a cGMP environment.

• Experience in cGMP Quality Control, preferably in Biologics or Cell and Gene Therapy settings.

• Solid scientific knowledge and hands-on lab experience with analytical methods and aseptic techniques.

• Ability to independently perform experiments for assay development, product release/stability/characterization with minimal supervision.

• Strong understanding of Good Manufacturing Practices (cGMPs).

• Excellent attention to detail, organizational skills, and proficient written and verbal communication skills.

• Knowledge and ability to apply basic scientific and regulatory principles to solve operational and routine quality tasks.

Additional Skills & Qualifications

• Experience with recombinant protein and monoclonal antibody (mAb) QC testing.

• Empower software experience is a plus.

• Familiarity with Liquid Chromatography and dynamic light scattering.

Work Environment

This position operates within an office, lab, and GMP environment. The role requires 40 hours per week with opportunities for overtime when needed. Core hours are typically from 8/9 AM to 5 PM. The team consists of 9-10 people, offering a great culture with significant cross-training opportunities. The company provides 11 paid holidays and accrues 2 weeks of PTO per year.

Pay and Benefits

The pay range for this position is $40.00 - $50.00/hr.

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 is anticipated to close on Feb 10, 2025.

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.