QC Scientist I (Bioassay)

Job Title: QC Scientist I (Bioassay)

Job Description

The QC Scientist I (Bioassay) supports Good Manufacturing Practice (GMP) manufacturing by performing analytical testing for commercial products and stability studies in a cGMP laboratory environment. You will use a range of analytical tools for large molecule analysis, including compendial methods, enzyme activity assays, and bioassays, to ensure timely and accurate testing of in-process, drug substance release, and stability samples. This role offers structured training, exposure to advanced analytical technologies, and the opportunity to grow within a collaborative, development-focused culture.

Responsibilities

• Perform ELISA, compendial testing (pH, UV, osmolality, appearance), enzyme activity assays (including temperature and incubation parameters), and other bioassays on in-process, drug substance release, and stability samples to support GMP manufacturing and stability programs.
• Operate analytical instruments such as spectrometers, plate readers, and other minor laboratory equipment to execute assigned test methods accurately and efficiently.
• Conduct GMP testing in an analytical laboratory using HPLC and UPLC methods, including reverse phase, size-exclusion chromatography (SEC), concentration measurements, cation-exchange chromatography (CEX), and related techniques.
• Compile, analyze, and interpret test data, document results according to Standard Operating Procedures, and prepare clear and accurate reports.
• Review laboratory data packets as assigned to ensure completeness, accuracy, and compliance with applicable procedures and regulations.
• Perform and author laboratory investigations, including out-of-specification (OOS) and out-of-trend (OOT) assessments, as assigned by laboratory leadership.
• Recognize and promptly report invalid results, laboratory incidents, and out-of-specification or out-of-trend results to laboratory management, and recommend appropriate corrective actions or solutions.
• Contribute to the development and optimization of new analytical concepts, techniques, and standards to improve laboratory efficiency and data quality.
• Collaborate closely with team members, quality assurance, and data reviewers to ensure alignment, resolve issues, and maintain high-quality standards.
• Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, and safety guidelines to maintain a compliant and safe laboratory environment.
• Participate in routine laboratory activities, including safety inspections, housekeeping, and ordering or managing laboratory supplies.
• Engage fully in the structured training program by successfully completing required testing qualifications on each method before progressing to additional assays.

Essential Skills

• At least 1 year of proven experience working in a GMP regulated environment, including hands-on ELISA testing.
• Demonstrated experience performing compendial testing such as pH, UV, osmolality, and appearance measurements.
• Practical experience conducting enzyme activity assays, including control of temperature, incubation, and other critical parameters.
• Proficiency in operating spectrometers and plate readers for quantitative and qualitative analyses.
• Strong qualitative pipetting skills, including accurate and consistent pipetting technique.
• Ability to conduct GMP testing using HPLC and UPLC methods, including reverse phase, SEC, concentration measurements, and CEX, in an analytical laboratory setting.
• Working knowledge of EMPOWER or similar chromatography data systems and familiarity with MS Office and laboratory computer programs.
• Bachelor’s degree in pharmaceutical sciences, biology, chemistry, biotechnology, or a related scientific field.
• Strong organizational and planning skills, with the ability to manage multiple tasks in a regulated environment.
• High attention to detail and accuracy in data recording, documentation, and review.
• Flexible, positive, and collaborative approach to working in a team-based laboratory setting.

Additional Skills & Qualifications

• Experience with SoloVPE for concentration or related measurements.
• Familiarity with qPCR techniques and workflows.
• Hands-on experience with colorimetric assays such as Picogreen and Bradford.
• Experience working with 96-well plates and multi-channel pipettes for high-throughput testing.
• Exposure to peer data review processes in a quality control environment.
• Experience conducting or contributing to investigations, including out-of-specification (OOS) and out-of-trend (OOT) assessments.
• Experience in quality control, wet chemistry, bioassays, and UV-Vis analytical techniques.
• Strong general computer literacy and comfort working with laboratory information and documentation systems.
• Demonstrated ability to adapt to changing priorities and learn new methods and technologies quickly.

Work Environment

This position is based in a pharmaceutical quality control laboratory where you will perform bench-level analytical work in a cGMP-compliant setting. The role includes an intensive training period of approximately 3 to 6 months, during which you will qualify on each test method before progressing to additional assays. You will work Monday through Friday with a standard daytime schedule and a flexible start time around typical business hours. The environment is highly regulated and safety-focused, with established Standard Operating Procedures, Good Manufacturing Practices, and safety guidelines governing daily activities. You will have access to modern analytical equipment, including HPLC, UPLC, spectrometers, plate readers, and related bioanalytical tools. The culture emphasizes continual growth, learning, and empowerment, with opportunities to convert to a full-time role based on performance and to contribute meaningfully to advancing pharmaceutical products.

This is a Contract to Hire position based out of Berkeley, MO.

The pay range for this position is $28.00 - $31.00/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)

This is a fully onsite position in Berkeley,MO.

This position is anticipated to close on Jun 26, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $28 - $31