Associate II, Chemistry, Process Development

Abzena Inc.•Bristol, PA

2d•Onsite

About The Position

The Associate II will design and conduct research, troubleshoot, and solve problems arising during synthetic route/process development. The associate II will also develop safe and efficient synthetic processes that can be scaled-up reliably and reproducibly adhering to EHS and regulatory guidelines.

Requirements

B.S degree in Chemistry or Chemical Engineering and at least three years’ work experience as process research and development chemist in an industry laboratory.
Knowledge and experience of analytical techniques and compound characterization.
Strong capability in MS Office suite

Nice To Haves

Knowledge and experience in a GMP environment preferred.
working with ERP and ELN systems a plus.

Responsibilities

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.
Lead a team in the development of new processes to manufacture Active Pharmaceutical Ingredient (API) for early development through Phase II clinical trials.
Ensure 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.
Manage the chemical process development, kilo-lab and pilot plant scale-up of API with contributions to broader CMC and regulatory activities.
Remain responsible for contributing to the planning of synthetic routes, the execution and of chemical synthesis projects.
Perform 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.
Provide 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