Analytical Development Scientist

Analytical Development Scientist

Job Description

We are seeking an Analytical Development Scientist to join our innovative biotechnology team focused on developing breakthrough therapies, particularly in oncology. The role involves developing, optimizing, and validating analytical methods for GMP testing of biological products. This position offers an opportunity to contribute to the full drug development lifecycle, from research to cGMP manufacturing, all while adhering to laboratory safety policies.

Responsibilities

• Develop and optimize analytical methods such as HPLC, capillary electrophoresis, and subvisible particles.
• Validate test methods in accordance with ICH Q2(R2) guidelines.
• Collaborate with cross-functional teams, including R&D, QA, and manufacturing.
• Author Standard Operating Procedures (SOPs), protocols, and reports for analytical method development and validation studies.
• Conduct biochemical, physical, and chemical analyses of test samples under cGMP compliance to meet specified timelines.
• Provide technical support and troubleshoot test methods as needed.
• Conduct Out-of-Specification (OOS), Out-of-Expectation (OOE), and Out-of-Trend (OOT) investigations.
• Initiate and author deviation and laboratory investigations.
• Maintain the laboratory in an inspection-ready state.
• Train analysts on test methods and procedures.
• Author Change Control records and lead the revision of written procedures.
• Ensure compliance with cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements.

Essential Skills

• Familiarity with cGMP regulations, including 21CFR 210 & 211, USP, EP, and ICH.
• Strong analytical, problem-solving, and troubleshooting skills.
• Ability to follow written instructions and perform tasks with direct or minimal supervision.
• Capability to work independently as well as in a team environment.
• Proficiency in using computers, including Windows, Microsoft Word, and Excel.
• Excellent written and verbal communication skills.
• Strong documentation skills.
• Experience with Protein analytics, SDS-PAGE, HPLC separations technology, Chromatography Data Systems (CDS) software such as OpenLab, subvisible particles testing (USP <788>), and spectrophotometry.

Additional Skills & Qualifications

• Bachelor's degree in Science or a related field, with a major in biology, biochemistry, or chemistry.
• Minimum of 8 years of relevant laboratory experience is desired.

Work Environment

The role is situated in a dynamic biotechnology setting, involving interactions with cross-functional teams. The work requires the ability to occasionally lift and/or move up to 25 pounds. The position demands specific vision abilities such as close vision, depth perception, and the ability to adjust focus. The work environment emphasizes safety and compliance with regulatory standards, with potential for overtime as necessary.

This is a Contract to Hire position based out of Vacaville, CA.

The pay range for this position is $60.00 - $72.00/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 Vacaville,CA.

This position is anticipated to close on Apr 17, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $60 - $72