Apply on Employer Site

Abzena · 10 hours ago

Lead Production Services Associate

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$75K/yr - $85K/yr

4+ years exp

Abzena is a company specializing in the development of biologics and bioconjugates, committed to delivering high-quality products and services. The Senior Production Service Associate will lead production services, train associates, and ensure compliance with GMP standards while managing production operations in a single-use facility.

BiopharmaBiotechnologyLife SciencePharmaceutical

Responsibilities

Perform a variety of complex tasks in accordance with cGMP

Operate/ maintain/ and schedule use for production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense

Schedule and maintain daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment

Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging

Provide hands-on training for staff to ensure compliance with training on all activities prior to GMP execution

Ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records

Schedule day-to-day work scheduled activities in support of production schedules. Support floor operations for multiple projects simultaneously

Competent in Upstream and Downstream Operations

Provide cross train on various tasks including Upstream/Downstream cGMP manufacturing

Adhere and train staff on appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms

Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF)

Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique

Monitor processes and results and troubleshooting issues as they arise to ensure process success

Provide detailed observations, analyze data and interpret results

Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways

Guide associates through process and workflow improvement initiatives

Enforce cleanroom standards for cleanliness and order

Communicate effectively with supervisors, colleagues, and staff to provide status of floor operation to management on a regular basis

Direct floor operations for multiple projects simultaneously

Adjust as necessary to adhere to production schedules

Review GMP records for completeness, accuracy, and compliance daily in conformance with regulatory requirements

Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation

Identify and initiate deviations, assist in assessing product quality impact, and assisting with proposals for Corrective and Preventative Actions (CAPA)

Adhere to quality standards set by regulations and Abzena policies, procedures, and mission

Operate to the highest ethical and moral standards

Qualification

CGMP knowledgeSingle-use technologiesBioprocessing aptitudeUpstream operationsDownstream operationsTrainingCoachingComputer proficiencyBasic arithmeticCommunication skills