ADC Directory
Sr Associate, MSAT (Manufacturing, Science and Technology)
ADC Directory, San Diego, California, United States, 92189
Sr Associate, MSAT (Manufacturing, Science and Technology)
Abzena
6325 Lusk Blvd, San Diego, CA 92121, USA $120,000.00 Full-Time
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. GMP Services is a partner of MSAT ( Manufacturing, Science and Technology ) and maintains a versatile and collaborative role with the departments of Manufacturing, Quality Assurance and Operational Excellence. GMP Services ensures manufacturing processes are capable, compliant, controlled, cost effective, and continuously improved.
Responsibilities
Continuously seek value and improve the Manufacturing Training curriculum. Administer the Training Program for onboarding and the development of Manufacturing staff and Trainers. Initiate, execute, and plan staff training as needed to support GMP manufacturing. In collaboration with Manufacturing Management, assign and track training to ensure compliance. Provide On-The-Job (OJT) training to staff on the floor. Support batch record review, as needed. Support root cause investigations and corrective actions, as needed. Support document revisions and other authoring tasks, as needed. Provide metrics to senior management and provide insight into areas for improvement. Escalate issues and proactively address roadblocks. Operates to the highest ethical and moral standards. Complies with Abzena's policies and procedures. Adheres to quality standards set by regulations and Abzena policies, procedures and mission. Communicate effectively with clients, supervisors, colleagues and staff. Prepare and present training tracking information to clients and regulatory agencies. Ability to participate effectively as a team player in all aspects of Abzena's business. Demonstrates administrative leadership with knowledge-based expertise in related areas that can be applied to meet Abzena’s strategic goals.
Qualifications
Minimum Bachelor's degree in scientific or engineering discipline, or equivalent with at least 3 years of relevant GMP Manufacturing experience. Working knowledge of upstream or downstream unit operations, and Abzena general operations. Well-experienced with operations of single-use technologies and aseptic processing techniques. Strong knowledge of MS Office including Excel, PowerPoint, and Word. Must have experience within biologics CMC that includes pilot plant and/or cGMP manufacturing. Must be able to demonstrate sound judgment and problem-solving capabilities with exceptional interpersonal skills. Strong organizational skills are required.
Physical Requirements
Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Frequently lift and or move objects up to 30 pounds. Stand/walk during entire length of shift. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
FLSA:
Non-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. #J-18808-Ljbffr
Abzena
6325 Lusk Blvd, San Diego, CA 92121, USA $120,000.00 Full-Time
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. GMP Services is a partner of MSAT ( Manufacturing, Science and Technology ) and maintains a versatile and collaborative role with the departments of Manufacturing, Quality Assurance and Operational Excellence. GMP Services ensures manufacturing processes are capable, compliant, controlled, cost effective, and continuously improved.
Responsibilities
Continuously seek value and improve the Manufacturing Training curriculum. Administer the Training Program for onboarding and the development of Manufacturing staff and Trainers. Initiate, execute, and plan staff training as needed to support GMP manufacturing. In collaboration with Manufacturing Management, assign and track training to ensure compliance. Provide On-The-Job (OJT) training to staff on the floor. Support batch record review, as needed. Support root cause investigations and corrective actions, as needed. Support document revisions and other authoring tasks, as needed. Provide metrics to senior management and provide insight into areas for improvement. Escalate issues and proactively address roadblocks. Operates to the highest ethical and moral standards. Complies with Abzena's policies and procedures. Adheres to quality standards set by regulations and Abzena policies, procedures and mission. Communicate effectively with clients, supervisors, colleagues and staff. Prepare and present training tracking information to clients and regulatory agencies. Ability to participate effectively as a team player in all aspects of Abzena's business. Demonstrates administrative leadership with knowledge-based expertise in related areas that can be applied to meet Abzena’s strategic goals.
Qualifications
Minimum Bachelor's degree in scientific or engineering discipline, or equivalent with at least 3 years of relevant GMP Manufacturing experience. Working knowledge of upstream or downstream unit operations, and Abzena general operations. Well-experienced with operations of single-use technologies and aseptic processing techniques. Strong knowledge of MS Office including Excel, PowerPoint, and Word. Must have experience within biologics CMC that includes pilot plant and/or cGMP manufacturing. Must be able to demonstrate sound judgment and problem-solving capabilities with exceptional interpersonal skills. Strong organizational skills are required.
Physical Requirements
Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Frequently lift and or move objects up to 30 pounds. Stand/walk during entire length of shift. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
FLSA:
Non-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. #J-18808-Ljbffr