Research Associate

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Company: Actalent

Location: Newark, CA 94560

Description:

Description

Seeking a Research Associate or Associate Scientist to contribute to our growing Analytical Development team. The candidate will participate in a team responsible for all aspects of method development, qualification, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for projects. This is an on-site, technical laboratory-based position that involves development, validation, and execution of analytical methods for testing of biologics. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support. ESSENTIAL DUTIES and RESPONSIBILITIES: Execute technical analytical methodologies to support development and validation of test methods. Author and review analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control. Operate and maintain (as well as overseeing the installation of) sophisticated analytical instrumentation and associated computer control systems. Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development area. Provide support for laboratory operations - inventory tracking, reagent preparation, sample management, and documentation review. Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations. Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.

Skills

HPLC, ELISA, Western Blot, uv vis

Top Skills Details

HPLC,ELISA,Western Blot,uv vis

Additional Skills & Qualifications

Skills: QUALIFICATION REQUIREMENTS: Experience performing basic analytical assay techniques such as absorbance assays (UV/VIS and Bradford), liquid chromatography (HPLC/UPLC), CE-SDS, ELISA, and western blot. Familiarity in interpreting data from common characterization techniques such as AUC, LC, LC/MS, MFI, DLS, and CD. Experience developing/authoring protocols, methods, and SOPs. Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution. Strong written and verbal communication skills. Working knowledge of statistics; R, Python, or other statistical tools preferred. Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills. Self-motivated, proactive and driven individual with an interest in experimental design and development. GxP knowledge. STRONG PREFERENCE WILL BE GIVEN TO: Strong experience in Liquid Chromatography and Immunoassays is highly desired. Experience in drafting protocols, methods, and/or procedures. Experience or working knowledge in neurotoxin as therapeutics. Experience in performing change control, deviation, laboratory investigation, and/or other quality records. Education: Advanced degree in biological sciences or related field with 3+ years of progressive experience in the biotechnology or biopharmaceutical industry, or bachelor's degree in biological sciences or related field with 6+ years of progressive experience in the biotechnology or biopharmaceutical industry. (Outstanding academic achievements may be considered in combination of industry experience)

Experience Level

Intermediate Level
Pay and Benefits
The pay range for this position is $41.00 - $55.85/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 Newark,CA.
Application Deadline
This position is anticipated to close on Apr 24, 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 for other accommodation options.

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