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 Manager of GMP will support the clinical phase manufacturing operations at Abzena. This role provides leadership and oversite of the GMP function with regards to compliance in deviation investigations, training and development, batch record review and release, and micro scheduling for the GMP function, ensuring department needs are met.
Manage, hire, mentor and coach staff.
Provide employee performance reviews, helpful feedback and training opportunities to GMP Staff.
Resolve conflicts or complaints.
Oversee the Batch Record Review process
Schedule the manufacturing unit and subunit operations in the GMP department
Establish training programs, ensuring all manufacturing employees receive appropriate training.
Generates deviations and CAPAs as needed; performs review and revision of deviations, major investigations and CAPAs
Approve purchase requisitions in Inventory system
Provides metrics to Sr management, provide insight into areas for improvement
Identifyissues and provide recommendations to site leadership,proactivelyaddressroadblocks
Initiates and monitors change controls as needed to support GMP manufacturing
Oversee internal and client audit responses from generation through to closure; assist with client visits and audits as needed
Operate to the highest ethical and moral standards.
Comply with Abzena's policies and procedures.
Communicate effectively with clients, supervisors, colleagues and staff.
Participate effectively as a team player in all aspects of Abzena's business.
Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
Perform other duties as assigned.
Minimum Bachelor's degree in scientific or engineering discipline, or equivalent with at least 5 years of relevant GMP Manufacturing/Quality experience.
Supervisory/Lead experience a must
Working knowledge of upstream and downstream unit operations
Well-experienced with operations of single-use technologies and aseptic processing techniques.
Strong knowledge of MS Office including Excel, PowerPoint, and Word.
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
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.
Abzena is the leading end-to-end bioconjugate, ADC, and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK.
