Quality Control Scientist III

The Company

Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Our facility in San Antonio, Texas specializes in working with start-ups, emerging biotechs, and academic researchers.  Scorpius was founded by a serial biotech entrepreneur determined to make small-volume programs a big priority. Clients benefit from decades of expertise taking large molecule drugs to market and can rely on Scorpius to offer Quality, Speed, Flexibility, & Responsiveness.

Position Summary 

Reporting directly to the Manager, Quality Control, the Quality Control Scientist III, demonstrates full understanding of scientific and technical aspects of biological Drug Product/ Drug Substance (DP/DS), as well as technology transfer, assay qualifications and validations activities. The Quality Control Scientist III is responsible for performing routine, In-process, and stability testing of drug products and analysis of raw materials, intermediates, and finished products, utilizing various analytical techniques and methods. The Quality Control Scientist III is involved in all aspects of quality control processes, from release of raw material and finished product to stability program execution.

This job might be for you if you enjoy working in a fast-paced environment and you have the skills to balance multiple tasks, prioritize them, and complete them independently while excelling at keeping all impacted parties well-advised. 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 at Scorpius BioManufacturing.

Key Responsibilities

• Conduct assays and lab procedures according to and in compliance with cGMP guidelines and internal SOPs.
• Performing routine, In-process and stability testing analysis of raw materials, intermediates, and finished products, utilizing various analytical techniques and methods.
• Ensure testing is completed in compliance with all applicable procedures, standards, and cGMP regulations.
• Work with Analytical Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• Ensure all analytical data from the laboratory is accurate, precise, robust and is generated following methods, specifications, and procedures.
• QC Scientist III will be expected to perform duties including, but not limited to, routine analytical testing, method development and validation, method transfer, and equipment purchase and qualifications.
• QC Scientist III will be required to write or revise SOPs, analytical procedures, analysis reports, validation/qualification documents, etc. May serve as a technical leader for internal/client-based projects.
• Ensure compliance with training, testing, documentation, and general lab maintenance requirements for industry standards and/or regulations.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Investigate Out-of-Specification (OOS) results and laboratory deviations, conduct root cause analysis, and implement CAPA.
• Ensure successful method transfer, including training of personnel for execution and review, review of data, and completion of documentation.
• Responsible for ensuring all QC laboratory equipment is maintained and calibrated according to schedule.
• Shifts may include routine weekend and evening work as required by the manufacturing process.
• Train junior staff on new methods of 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, FDA, ICH, EMA 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, qPCR, Western Blotting, 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, change control, OOS Investigation, CAPA
• Working experience with analytical method validations.
• Working experience with training analysts on new transfer methods.
• Working experience within cGMP industry.
• Previous experience using cGMP 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 Biotechnology, Chemistry, Biological Sciences Microbiology, Biochemistry or equivalent field.
• 3+ years of relevant experience or equivalent for Bachelors’ or 2+ years of relevant experience or equivalent for master’s or 1+ years of relevant experience or equivalent for PhD.

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 the ability to adjust focus. The employee must have manual dexterity and manual ability to effectively use computer terminals.