Lead Manufacturing Associate Upstream

United States·Tustinlead

OtherManufacturing Associate

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Quick Summary

Overview

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Key Responsibilities

The Lead Manufacturing Associate Upstream will undertake leadership responsibilities in cGMP contract cell culture manufacturing within a multi-product facility.

Requirements Summary

You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. Your written and verbal skills are out of this world, and you communicate with clarity and confidence.

Technical Tools

OtherManufacturing Associate

Your Role:

The Lead Manufacturing Associate Upstream will undertake leadership responsibilities in cGMP contract cell culture manufacturing within a multi-product facility. This role involves assisting supervisors in various tasks, including but not limited to overseeing production processes, proposing improvement ideas, and managing additional assignments efficiently.

Acting as a liaison between management and operators, the Lead Manufacturing Associate will ensure clear communication of directives and decisions, fostering alignment and understanding among the team. This role is crucial in guaranteeing the production and timely release of high-quality products.

The Lead Manufacturing Associate will perform required tasks while embodying the core virtues of being hungry, humble, and smart. They will represent the company’s core values of Integrity, Adaptability, Innovation, Teamwork, and Passion, all with the shared goal of enhancing patients’ lives through the consistent delivery of high-quality biopharmaceutical products.

Knowledgeable of the following equipment (including but not limited to):

Wave and 100L-2000L SUB using Cytiva, Delta V and MFCS program.
NOVA analyzer, pH meter, Beckman Coulter Vi-Cell, 3M or Millipore Pods Filtration, Sartocheck filter tester and Alfa-Laval Centrifuge.

Lead critical process with your assigned functional group (including but not limited to):

Ability to perform aseptically under the BSC and to ensure quality execution and documentation for thaw, expansion and maintenance of the cell culture.
Ability to perform cGMP activities on the floor and ensure quality execution and documentation for bioreactor’s setup, media and feed addition, inoculation and harvest process.

Lead troubleshooting efforts on the floor, addressing equipment and process issues. Ensure proper escalation, propose solutions for path forward, and suggest improvements.
Lead in planning ahead, scheduling, and collaborating with various departments to ensure the team is fully prepared to execute processes without delay.
Lead on internal manufacturing improvement projects including but not limited to:

SOP Improvement Team to track and revise Standard Operating Procedures.
Facility Improvement Team to track equipment health, readiness, and always keeping clean room areas compliant for inspections and audits.
Process and Equipment Efficiency team to drive on-the-job training.
BPR Improvement Team to review and ensure Batch Production Record is accurately drafted and aligned with current operations’ practices.
Closing of Upstream Record Team to ensure all documents are reviewed and submitted in a timely manner with no GDP errors.

Support supervisor(s) or specialist(s) in developing future leader(s) or process subject matter expert(s) within your team.
Ability to manage time efficiently and demonstrate continuous self-improvement by enrolling in and completing the Avid Performance System program (APS) without impacting processes and/or assigned tasks.

Minimum Qualifications:

Bachelor’s degree (B.A.) or equivalent from four-year college or university plus 3-4 years related experience and/or training; or equivalent combination of education and experience.
Minimum of 2 years of industry experience working with mammalian cell culture.

Position Type/Expected Hours of Work:

This role is a full-time position with a Wednesday through Saturday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 7:00am to 6:00pm. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $31.77 to $42.35 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.