Senior Process Development Associate

Overview

On Site
Depends on Experience
Contract - W2
Contract - 6 Month(s)

Skills

Downstream
Filtration
Purification
Documentation
GDP
GLP
SOP
Bioprocess
Chromatography
HPLC

Job Details

BRIEF DESCRIPTION OF DUTIES:

Job Title: Senior Process Development Associate-C
Location: San Diego, California, 92111 (Onsite)
Duration: 6 Month contract (40hrs./week)

Job Description: Downstream Pilot Plant Associate
Responsibilities (Essential Role Responsibilities):
Perform downstream purification processes, including chromatography, ultrafiltration, tangential flow filtration and depth filtration, at pilot and production scales.
Operate and maintain standard bioprocessing equipment such as chromatography systems, ultracentrifuges, and tangential flow filtration (TFF) units.
Adhere strictly to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in all activities.
Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, campaign summary reports, technology transfer documents, and presentations in compliance with regulatory requirements.
Collaborate with cross-functional teams to support manufacturing investigations, root cause analysis, and process troubleshooting.
Ensure compliance with company SOPs, training requirements, and scale-up best practices.
Maintain facility readiness and support regulatory inspections through vigilant oversight.
Utilize Quality Systems and ERP platforms to document and track manufacturing activities.
Drive process improvements through the change control process or other initiatives.
Apply professional expertise to routine assignments; may supervise or serve as lead during on-floor activities.
Provide process subject matter expertise and take ownership of assigned deliverables.
Preferred: Experience conducting manufacturing investigations in biologics production.
Demonstrate strong technical writing and communication skills.
Maintain a safe working environment and stay current with all assigned training.

Qualifications:
B.S. degree in biology or related area with 4-6 years of experience working in process development or Manufacturing support in bioprocessing required
Hands on experience with Chromatography, ultrafiltration and depth filtration process acquired through lab, pilot or production scale experience.

The hourly range for roles of this nature are $45 to $75/hr. Rates are heavily dependent on skills, experience, location and industry.
CyberThink is an Equal Opportunity Employer.

Best Regards,
Anas Bin Iqbal

Work:
cyberThink Inc.
Bridgewater, NJ 08807-1774
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