Job Details
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 ability to design and conduct research, troubleshoot, and solve problems arising during synthetic route/process development. Develop safe and efficient synthetic processes that can be scaled-up reliably and reproducibly adhering to EHS and regulatory guidelines.
Responsibilities
- Leading a team in the development of new processes to manufacture Active Pharmaceutical Ingredient (API) for early development through Phase II clinical trials.
- Ensuring that processes are suitable for controlling the quality of API as required by cGMP, ICH and FDA regulations as well as the attributes conducive to successful formulation development.
- Managing the chemical process development, kilo-lab and pilot plant scale-up of API with contributions to broader CMC and regulatory activities.
- Responsible for contributing to the planning of synthetic routes, the execution and of chemical synthesis projects.
- The preparation, purification, and characterization of all materials, maintaining clear and current records of your work within a laboratory notebook, performing analytical work, attending and contributing to meetings, writing comprehensive reports and purchasing all necessary supplies and equipment.
- Maintain a safe, pleasant, and efficient working environment.
- Thorough documentation and authoring of SOPs, investigations, lab notebooks, batch records, deviations, CAPA and other relevant tech documents as applicable.
- Follow safety procedures for organizational policies
- Identify opportunities for improvement or optimization in current processes and implement viable solutions Investigate route modifications to limit cytotoxicity until the final step to reduce the cost of goods and increasing overall safety.
- Exhibit detailed record-keeping, data analysis and chain of custody controls required in successful implementation of GMP.
- Perform other duties as assigned.
Qualifications- This position required PhD degree in Organic Chemistry or Chemical Engineering and at least five years' work experience as process research and development chemist in an industry laboratory.
- Knowledge and experience in a GMP environment preferred.
- Knowledge and experience of analytical techniques and compound characterization.
- Excellent oral and written communication/interpersonal skills; ability to speak clearly and persuasively in positive or negative situations with demonstrated leadership with both internal and external customers.
- Strong capability in MS Office suite and working with electronic lab notebook systems (ELN). ERP system use is a plus.
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.