Position Summary

The Process Validation Project Manager works closely with process development and technology transfer to transfer processes from clinical phases to commercial. The primary responsibility is to manage the process verification and validation program. This position supports the tech transfer and process qualification efforts at the Contract Manufacturing Organization.

Location: Emeryville, CA

Travel: Travel may be required (up to 10%)

Primary Responsibilities:

• Key team member driving process verifications.
• Develops business process and standard operating procedure(s) for process verifications.
• Coordinates preparation for and execution of process verifications.
• Participates and/or leads process improvement projects.
• Contributes to development of process validation strategies, protocols and other documentation for products.
• Reviews/assesses proposed changes to validated processes via CAPA, Change Control to identify requirements necessary to maintain validated status.
• Works with QA to investigate process issues and perform root cause analysis and implement solutions.
• Interfaces with other departments (e.g., Engineering, Facilities, Manufacturing, Quality

Control and Quality Assurance) to ensure achievement of objectives relating to process validation and associated activities; including compliance with all applicable standards.

• Assists with preparation of regulatory submissions and inspections.

Qualifications:

• Bachelor’s Degree preferred in Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology with 5+ years of experience.
• Process validation experience in the pharmaceutical industry supporting commercial cGMP areas preferred.
• Direct experience participating and supporting regulatory inspections and submissions focused on process validation.
• Experience with Technology Transfer process.
• Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions critical.
• Proven project management skills required.
• Must possess excellent verbal and written communication skills; good interpersonal skills.
• In-depth knowledge of industry and company regulations (GMP, ICH, FDA, ISO, and EMA) and guidelines (PDA, ISPE)
• Experience in cGMP for cell therapy validation is a plus.
• Flexibility to travel as required to accommodate the business needs.
• Must be able to work in controlled environments requiring special gowning.

Job Types: Full-time, Contract

Pay: From $115,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• Hybrid remote

Education:

• Bachelor's (Required)

Willingness to travel:

• 25% (Required)

Work Location: Remote

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