Sr. Manager, Manufacturing Upstream

Avid Bioservices•Costa Mesa, CA

5d•$139,200 - $174,000•Onsite

About The Position

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. The Sr. Manager, Manufacturing Upstream will spearhead the development and management of a highly proficient team, while overseeing efficient GMP manufacturing operations in the upstream phase. This role leverages extensive knowledge of Lean Manufacturing principles and attention to detail to streamline processes, mitigate risks, and ensure strict adherence to compliance standards. It offers the chance to make a profound impact within a vibrant work environment where exemplary leadership and skills will thrive.

Requirements

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.

Nice To Haves

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.

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.