Scientist II

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 65,000 - 90,000; Full time

Job summary

Abzena is seeking an Associate II to design and conduct research, troubleshoot, and develop scalable synthetic routes for API production, from early development through Phase II trials. You will work with a team to ensure quality, regulatory compliance, and on-time delivery.

The role emphasizes safe handling of high-potency materials, adherence to EHS standards, and thorough record-keeping, with opportunities to contribute to CMC and regulatory activities within a collaborative environment.

Qualifications

• B.S. degree in Chemistry or Chemical Engineering.
• At least three years’ experience as a process research and development chemist in an industry laboratory.
• GMP environment experience preferred.
• Knowledge and experience of analytical techniques and compound characterization.
• Proficiency in MS Office; ERP and ELN systems a plus.

Responsibilities

• Lead development of new processes to manufacture API for early development through Phase II trials.
• Ensure processes are suitable for controlling API quality per cGMP, ICH and FDA regulations and support formulation development.
• Manage chemical process development, kilo-lab and pilot plant scale-up of API with contributions to broader CMC and regulatory activities.
• Prepare, purification, and characterization of all materials; maintain laboratory notebooks and records; write reports and SOPs.
• Maintain a safe, clean, and efficient working environment.
• Follow safety procedures for organizational policies and identify optimization opportunities to reduce costs and improve safety.

Education

B.S degree in Chemistry or Chemical Engineering

Tools

MS Office

ERP systems

ELN systems

Job description

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 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.

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

Qualifications

• 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 in a GMP environment preferred.
• Knowledge and experience of analytical techniques and compound characterization.
• Strong capability in MS Office suite and working with ERP and ELN systems a plus.

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.
• Ability to work with a PAPR and gown during work with high potent materials.

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.