Sr. Manager, Manufacturing Upstream

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:
Join our exceptional team as the Sr. Manager, Manufacturing Upstream and propel your career to new heights. As a pivotal figure in this role, you will spearhead the development and management of a highly proficient team, while overseeing efficient GMP manufacturing operations in the upstream phase. Leveraging your extensive knowledge of Lean Manufacturing principles and unwavering attention to detail, you will streamline processes, mitigate risks, and ensure strict adherence to compliance standards. Embrace the chance to make a profound impact within a vibrant work environment where your exemplary leadership and skills will thrive. Seize this opportunity to advance your career alongside us!

Key Responsibilities:

• Develop and train employees to strengthen their skills and expertise in upstream GMP manufacturing supporting clinical and commercial production.
• Strategize and coordinate the planning and scheduling of GMP manufacturing operations in the upstream phase, optimizing resource allocation for efficient and timely execution.
• Create and implement manufacturing SOPs, BPRs, and forms to establish standardized procedures and ensure strict compliance with regulations.
• Collaborate closely with supporting departments to seamlessly coordinate manufacturing activities and maximize overall productivity.
• Apply Lean Manufacturing principles to drive continuous improvement in operating systems, enhancing efficiency in upstream manufacturing processes.
• Actively participate in cross-functional team initiatives to achieve departmental and company-wide objectives, cultivating a culture of collaboration and innovation.
• Conduct thorough reviews of executed Batch History Records, ensuring their accuracy and compliance with established protocols.
• Adhere to all safety policies, practices, and procedures, prioritizing a safe work environment for all team members.
• Lead by example, providing guidance and sharing knowledge/skills to inspire and empower others.
• Fulfill additional duties as assigned, adapting to the evolving needs of the organization and actively contributing to its overall success.

Minimum Qualifications:

• Bachelor's degree in a relevant scientific or engineering field
• 4+ years of hands-on experience in GMP upstream manufacturing supporting clinical and commercial production, with a strong emphasis on cell culture, bioreactor operations, harvest, and associated process activities.
• 2+ years of leadership experience successfully managing teams and driving performance in GMP upstream manufacturing environments supporting clinical and commercial operations.
• In-depth knowledge of GMP regulations and industry best practices, ensuring compliance and upholding quality standards throughout upstream manufacturing operations.
• Excellent problem-solving skills, enabling the identification and resolution of process constraints and technical challenges encountered in upstream manufacturing.
• Knowledge of Lean Manufacturing principles and their application to optimize operating systems and drive process enhancements.
• Ability to effectively coordinate and collaborate with cross-functional teams and supporting departments to ensure streamlined operations.
• Excellent communication and interpersonal skills, facilitating impactful leadership, mentorship, and guidance to team members, promoting their professional growth and development.

Position Type/Expected Hours of Work: 

This role is a full-time onsite position in Costa Mesa, CA. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

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 $139,200 - $174,000 annually 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 25 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.