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    Supervisor, Manufacturing - Tustin, United States - Avid Bioservices

    Avid Bioservices
    Avid Bioservices Tustin, United States

    3 weeks ago

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    Description


    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.



    Your Role:
    As the

    Supervisor of Downstream Manufacturing , you have a pivotal role in ensuring the seamless operations and compliance of the manufacturing process.

    Not only do you supervise the Downstream manufacturing staff, but you also actively engage in hands-on activities.

    Your focus on maintaining full cGMP compliance drives you to observe, direct, and participate on the production floor, guaranteeing high-quality output.


    Leads and empowers associate-level employees, driving impactful actions across functional areas.
    Expertly coordinates production activities, meticulously planning and scheduling to optimize efficiency.

    Takes charge of crucial purification operations, such as column chromatography, nano-filtration, and tangential flow filtration, performing them directly on the production floor when necessary.

    Upholds the highest standards of cGMP documentation, ensuring accuracy and completeness.

    Takes the initiative to initiate, review, and revise essential documents like Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms, and Batch History Records (BHRs).

    Keen attention to detail enables you to identify, escalate, and meticulously document deviation reports (IRs/DRs/CAPAs), followed by appropriate corrective and preventative actions to maintain cGMP compliance.

    Actively contributes to the development of Standard Operating Procedures (SOPs), ensuring all manufacturing operations align with internal and external regulatory requirements.

    Effective collaboration with other departments enables skillful coordination of manufacturing, validation, and maintenance activities, streamlining operations.
    Takes the lead in setting up new manufacturing processes and critical equipment, ensuring seamless integration into the production line.

    Proactive approach allows you to identify and address technical, procedural, and equipment issues that hinder production and compliance, showcasing your problem-solving skills in overcoming challenges.

    Fosters open communication with team members, supervisors, and other departments, promptly resolving any issues that may arise.

    Minimum Qualifications:
    A related bachelor's degree, such as Biology, Biotechnology, or Chemical Engineering.
    3+ years of cGMP purification experience.
    1+ year of leadership experience or an equivalent combination of experience

    Preferred Qualifications:


    Demonstrated success in a leadership role, with 3+ years of experience in supervising and mentoring teams to achieve outstanding results.

    Exceptional communication skills, both written and verbal, enabling effective collaboration and the ability to convey complex information clearly to diverse audiences.

    Proficiency in maintaining and reviewing critical regulatory documentation, including Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and Batch History Records (BHRs).

    Demonstrated ability to collaborate effectively with other departments, fostering strong interdepartmental relationships and promoting a culture of teamwork.

    Position Type/Expected Hours of Work:
    This role is a full-time position operating Monday through Friday from 5:00pm - 2:00am PST.

    Physical Demands & Work Environment

    For this role, you may occasionally encounter environments with electrical risks, exposure to chemicals, vibrations, airborne particles, and wet or humid conditions.

    The noise level can be loud at times. We're committed to providing reasonable accommodations for those with differing abilities to perform essential job functions.

    In your daily work, you'll regularly need to sit, speak, hear, and use your hands for various tasks. Standing and walking are frequently required. Occasionally, you may need to climb, balance, or move in confined spaces. The role involves regularly lifting up to 10 pounds and occasionally up to 20 pounds. Clear close, distance, and color vision are also necessary.


    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.


    Compensation:


    We offer competitive compensation packages for this role, including a base salary, equity grants, 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 $

    67,700 - $90,300

    annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

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