Director of Manufacturing Chemistry
Bristol, PA
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 Director of Manufacturing Chemistry ensures Chemistry manufacturing processes are safe, scale-appropriate, compliant, in control, and continuously improved with strong collaboration from Process Development, Quality and EH&S. The incumbent will be responsible for leading a team that provides technical support for manufacturing readiness, EH&S compliance, and manufacturing operations through strong technical and cGMP input, establishing manufacturing standards to enable robust, safe and scalable manufacturing. The scope of this position includes leading a team of manufacturing process subject matter expert (SME), providing technical support for process development and scale up, technology transfer, process and equipment qualification, technical support during manufacturing.
Responsibilities
- Lead of team of manufacturing associates in the execution of manufacturing of chemical processes
- Support efforts related to transfer of chemical manufacturing technologies from process development to cGMP manufacturing
- Develop talent and to achieve results through teamwork and leadership of others, streamlined execution, and innovation in a matrix business unit environment
- Remain responsible for the transfer of technologies, including cross-department and client collaboration to enable facility fit, development of process documentation (Batch Records, Forms, SOP etc.), Change Control ownership, Investigations, and other quality system deliverables.
- Recommend strategies for improving manufacturing processes for top performance using sound engineering and scientific principles.
- Lead process control strategies development, including execution of process risk assessment, process parameters range justifications, and criticality assessment.
- Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of product development studies and data.
- Network with Process Development and Quality organizations to establish a reliable state of process control.
- Provides training as needed and ensures adherence to company policies and quality requirements.
- Ensures budgets, schedules, and performance requirements are met as they pertain to client deliverables
- Improve product quality and cost and reduce customer complaints through a proactive program that includes interaction with internal and external suppliers. Utilize collected data from customers to enhance perceived product quality.
- Assess and implement measures to detected and de-risk safety concerns inherent to the manufacturing processes and operations
- Establish lean practices and a continuous improvement mindset throughout operations and the direct supporting organizations.
- Operate to the highest ethical and moral standards.
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
- Communicates effectively with supervisors, colleagues, and staff.
- Ability to participate effectively as a team player in all aspects of Abzena's business.
- Performs other duties as assigned
Qualifications
- Degree in Organic Chemistry or Chemical Engineering, or a master’s degree with equivalent experience. PhD in organic chemistry or chemical engineering preferred
- 10 years of relevant industry experience as a minimum, with 15 years preferred
- Chemist by training, with experience in process scale up from development to manufacturing
- Process development experience with a focus on scale up product isolation
- Experience in managing direct reports andleading projects
- Knowledge of process safety
- Experience with process transfer and scale-upfrom R&D to a GMP environment
- Skilled or experienced in analytical techniques
- Late phase process development experience is preferred
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.
