Manufacturing Manger / Sr Manager

Abzena Inc.•San Diego, CA

1d•$100,000 - $150,000

About The Position

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Manufacturing Manager / Senior Manager will primarily be responsible for overseeing all Downstream/Upstream operations and performance manage a team of associates by means of training, mentoring and coaching.

Requirements

BS in biotechnology, or a 4-year technical degree in related discipline.
8+ years experience in bio-manufacturing management, preferably in a process-oriented operation, or experience managing a major segment of a large manufacturer.
Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities.
Knowledge of purification using column chromatography
Experienced with using single-use technologies
Experience interacting with regulatory agencies.
Computer proficiency, with the ability to present metrics/data.
A proven ability to confidently compute basic arithmetic operations.

Responsibilities

Manage a Downstream/Upstream shift team for top performance by providing technical, tactical and professional guidance.
Schedule, plan, coordinate and support production activities.
Perform frequent Gemba walks to identify the technical, procedural and equipment issues that hinder production and compliance and to enforce cleanroom standards for cleanliness and order.
Monitor processes and results and troubleshoot issues as they arise to ensure process success.
Communicate with associates and cross-functional teams, as appropriate, to assure prompt resolution to problems.
Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
Lead and guide associates through process and workflow improvement initiatives.
Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging.
Direct floor operations for multiple projects simultaneously
Remain responsible for operational performance and improvement of key metrics including safety, quality, delivery, cost, and morale.
Provide hands-on training by guiding Downstream staff through operations to ensure compliance with training on all activities prior to GMP execution.
Facilitate team cross-training opportunities for various tasks including autoclaving of assemblies, formulation of media and buffers, and Upstream operations to support overall success of the Biologics group.
Perform annual and semi-annual reviews and track performance to provide associates with career growth and development opportunities.
Conduct interviews and hire personnel to achieve staffing objectives.
Assist with technical and compliance investigations, inspections, and audits.
Represent departmental activities as needed, including project teams and task forces.
Communicate effectively with clients, supervisors, colleagues, and staff and provide status of floor operation to leadership on a regular basis.
Manage the timely review of GMP records for completeness, accuracy, and compliance in conformance with regulatory requirements.
Draft, revise, and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation, as needed.
Prepare technical reports, batch summaries and protocols.
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 off-shift work, as needed.
Perform additional duties as assigned.