Lead Production Services Associate - Overnight Shift bei Abzena

The Senior Production Service Associate will primarily be responsible for organizing and leading production services and training associates involved in all aspects of production in a single use facility, including buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down operational equipment in accordance with the operations schedule



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. 

Adjust to a flexible work schedule including weekend work, as needed.  

Perform additional duties as assigned.

Qualifications

BA/BS degree in chemistry, biology, or related field.

At least 4 – 5 years of experience in a GMP pharmaceutical/biotech environment role.

Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities.  

Skilled with using single-use technologies

Strong technical and mechanical aptitude in bioprocessing.

Knowledge of upstream and/or downstream operations.

Experience leading, training, and coaching peers.

Computer proficiency

A proven ability to confidently compute basic arithmetic operations.

Physical Requirements

Physical ability to walk, stand and sit for extended periods of time.

Frequently lift and or move objects at least 30 pounds in weight.

Use arms, hands and fingers to handle, feel or reach.

Ability to climb, balance, stoop, kneel, crouch, or crawl.

Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus. 

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