Manufacturing Manager / Sr Manager
San Diego, CA
Manufacturing – Manufacturing /
Full Time /
On-site
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 will primarily be responsible for overseeing all GMP shift operations and manage a team of associates by means of training, mentoring, and coaching
Responsibilities
- Manage the Upstream and Downstream shift teams for top performance by providing technical, tactical, and professional guidance.
- Schedule, plan, coordinate and support Upstream and Downstream production activities.
- Direct floor operations for multiple projects simultaneously.
- 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 and delegate skills to effectively coordinate floor operations with staff and assure prompt resolution to problems.
- Lead batch readiness activities such as general planning and coordination, material requests and transfers, operator qualification, and material and equipment staging.
- Lead and guide associates through process and workflow improvement initiatives.
- Conduct interviews and hire personnel to achieve staffing objectives.
- Provide hands-on training and cross-training by guiding Upstream and Downstream staff through operations to ensure compliance on all activities prior to GMP execution.
- Perform annual and semi-annual reviews and track performance to provide associates with career growth and development opportunities.
- Remain responsible for operational performance and improvement of key metrics including safety, quality, delivery, and cost.
- Manage the daily review of GMP records for completeness, accuracy, and compliance in conformance with regulatory requirements.
- Initiate deviations, assess product quality impact, propose and execute Corrective and Preventative Actions (CAPA).
- Assist with technical and compliance investigations, inspections, and audits.
- Draft, revise, and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation, as needed.
- Represent departmental activities as needed, including project teams and task forces.
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
- Operate to the highest ethical and moral standards.
- Perform additional duties as assigned.
Qualifications
- BA/BS degree that included laboratory work in a chemistry, biology, chemical engineering or related filed or combination of relevant education and experience.
- 5-10 years of experience in a GMP pharmaceutical or biotech environment.
- Knowledge and understanding of cGMPs and how they apply to duties and responsibilities.
- Knowledge and skill with biologics manufacturing processes and equipment.
- Experience using single-use technologies and aseptic processing.
- Experience interacting with regulatory agencies.
- Computer proficiency, with the ability to present metrics/data
- A proven ability to confidently compute basic arithmetic operations.
- Shift schedule is Sunday to Wednesday with off-shift coverage as necessary.
$100,000 - $180,000 a year
Shift A schedule is Sunday to Wednesday with off-shift coverage as necessary.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
