Quality Control Scientist

Experience the Smoothest Path to Clinic

 The Company

Scorpius Biomanufacturing is an innovation-driven contract research, development, and biomanufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical method development, cGMP manufacturing, product characterization, release testing needs, and clinical trial support. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations.

Position Summary

Reporting directly to the Director, Quality Control, the Quality Control Scientist, demonstrates full understanding of scientific and technical aspects of biological drug substance testing as well as technology transfer, assay qualifications and validations, and be familiar with analytical development. The Quality Control Scientist is responsible for performing routine and non-routine analysis of raw materials, intermediates, and finished products, utilizing various analytical techniques and methods. The Quality Control Chemist will also be responsible for ensuring that all laboratory equipment is maintained and calibrated according to schedule and will assist in the preparation and review of Standard Operating Procedures (SOPs). The Quality Control Scientist is involved in all aspects of quality control processes, from release of raw material and finished product to stability program execution, including Environmental Monitoring. May also provide project and professional guidance to team members.

An ideal candidate must have strict attention to detail, high-quality customer service skills, and the ability to work well and collaborate in cross-functional teams.

Key Responsibilities

• Ensure successful method transfer, including training of personnel for execution and review, review of data, and completion of documentation.
• Conduct assays and lab procedures according to and in compliance with cGMP guidelines and internal SOPs
• Ensure that all analytical data from the laboratory is accurate, precise, robust and is generated by following methods, specifications and procedures.
• Ensure compliance to training, testing, documentation and general lab maintenance requirements for industry standards and/or regulations.
• Investigate any Out-of-Specification results and laboratory deviations, conduct root cause analysis, and implement CAPA.
• Prepares validation documents to support new products, process changes and qualifications.
• Participates in project team meetings.
• Train junior staff on new methods from tech transfers.

Knowledge & Skills

• Candidate must possess knowledge and experience in analytical and QC operations of pharmaceutical industry, understand current regulations and industry trends of biologics product development, characterization and manufacturing testing requirement including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
• Solid track record of working experience in quality control operation to support clinical and commercial scale manufacturing product testing and regulatory IND/BLA filing.
• Strong technical and scientific knowledge of general QC testing.
• Hands-on experience in modern analytical instruments, such as HPLC, UPLC, CE, iCE, ELISA, LC-MS/MS and Bioassays.
• Ability to evaluate technical data
• Provides training on areas of technical expertise and compliance issues relevant to the lab setting.
• Working experience with performing industry investigations/deviations.
• Strong working experience with analytical method validations.
• Working experience with training analysts on new transferred methods.
• Working experience within cGMP industry.
• Previous experience using GMP Quality Systems (ex. MasterControl).
• Experience with lab-based software systems such as: LIMS/ELN, Empower, including validation of templates within these systems.
• Excellent communication skills with the ability to collaborate across multiple teams and projects.
• Experience with speaking publicly. Able to maintain control of meetings as required.

Education & Experience

• Bachelor or advanced Graduate degree (MS/PhD) in Chemistry, Microbiology, Biochemistry or equivalent field.
• 3+ years of relevant experience or equivalent for Bachelors’, 2+ years for Master’s in the Quality Control or related field or equivalent experience.

Physical Requirements and Working Environment

• Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
• The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment.
• While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.