Scientist III, Quality Control (Large Molecules)

Job Title: Scientist III, QC (Large Molecules)

Department: Quality Control

Reporting To: QC Manager or above

Classification: Exempt

Salary Range: $80,319-$95,755

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 10 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

The Scientist III facilitates and assists in execution of systems to assure cGMP compliance for all relevant operations carried out within and for BioDuro LLC. Responsible for performing advanced experiments, managing teams for projects, and general laboratory duties.

Essential Functions and Responsibilities

• Conducts analyses with a good understanding of laboratory procedures and best practices, providing technical expertise to the team

• Develops and validates methods. Performs technical experiments accurately, consistently, and in a timely manner

• Authors, reviews, and revises SOPs, Test methods, Stability Protocols, and Specification documents

• Conducts lab investigations and Deviations. Investigates aberrant results, determines root causes, and recommends action plan

• Performs quality control analysis for raw materials, drug product, stability testing and final release testing, interpreting and communicating results effectively

• Expertise in performing analytical testing using HPLC/UPLC, GC, FTIR and KF. Experience with Dissolution Analysis is a plus

• Reviews completed Data Packets, providing guidance and insights to the team

• Trains and mentors’ junior chemists on lab activities and technical skills, as assigned

• Complies with all laboratory safety guidelines, ensuring team members adhere to PPE and other safety procedures

• Maintains general cleanliness of the lab, including personal bench space and common use areas, and ensures lab compliance with GMP regulations

• Performs data analysis using Excel spreadsheets and other necessary tools, interpreting data trends and making recommendations based on results

• All other tasks and duties assigned by senior management

• This job description is subject to change at any time

Requirements

• BS degree in Chemistry or related scientific discipline with 8 years’ experience
• MS in Chemistry or related scientific discipline with 6 years’ experience
• PhD in Chemistry or related scientific discipline with 4 years’ experience
• At least 6 years’ experience in an analytical chemistry or quality control laboratory in the pharmaceutical or contract testing organization.
• At least 6 years; experience in a GMP environment.
• Extensive experience with HPLC and other scientific and analytical instrumentation.
• Experience with method development strategies for SDS-PAGE Analysis
• Experience with potency assays, ELISAs, Dissolution testing
• Experience with Large Molecules

Preferred Qualifications

• Leadership experience in operational, technical and GMP oversight to the Quality Control department
• Experience supervising/managing/directing the selection, training, development, scheduling of projects and resources and work assignments of personnel
• Detailed attention in job performance
• Improvement on the quality system
• Good attitude, work ethic and natural leadership
• Achievement of an advanced degree or certification
• Excellent written and verbal communication

Benefits

We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure,