Quality Control Manager

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 Manager, will provide support in the Quality Control group at Scorpius BioManufacturing. The QC Manager will provide leadership in a fast paced, collaborative QC Analytical laboratory that supports GMP testing of clinical and commercial biological products in beautiful downtown San Antonio, TX. In addition to performing product testing, the Manger will provide cross-functional support for the DS stability programs, sample management, inventory of critical reagents and manage the daily laboratory activities of a team of scientists. The successful candidate will have extensive laboratory compliance experience, exceptional attention to detail and have experience designing and implementing laboratory efficiency improvements.

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

• Will manage team to perform a variety of protein and molecular-based assays following established test methods precisely with an attention to detail following Good Documentation Practices (GDP)

• Will analyze data and complete detailed reports with attention to detail.

• Will qualify/validate/transfer methods to support Good Manufacturing Practices (GMP) testing.

• Expands the technical capabilities of QC Group, such as technology development, use of literature, and systems development.

• Teaches others regarding their expertise, mentoring and training other members of the QC Group in regard to day-to-day lab goals and activities

• Interacts with clients and works with other supervisors and functions to ensure that collaboration goals are met.

• Other duties as assigned.

Education & Experience

• B.S. in Molecular Biology, Biology, Life Sciences, or related field, with 7+ years of relevant experience in pharmaceutical or biotechnology industry, or M.S in Molecular Biology, Biology, Life Sciences, or related field, with 5+ years of relevant experience in pharmaceutical or biotechnology industry or PhD in related field with 2+ years of relevant experience.

• Has a strong understanding of nucleic acids and protein biochemistry.

• Has experience with protein characterization techniques such as SDS-PAGE, Western Blot, ELISA, LC-MS/MS and protein quantification assays.

• Experience with experimental design, data interpretation, statistical analysis, and trending.

• Should have operated in a lead technical role from previous experience.

• Minimum supervision required on day-to-day activities and accomplished tasks.

 Knowledge & Skills

• Understand analytical method life-cycle management and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.

• Ability to make good judgements and quick decisions regarding analytical methodology.

• Facilitate with organizational agility.

• Develop, guide and support strategies on how to achieve what needs to be done and develop metrics to measure the strategy.

• Are an expert in Analytical Test Methods associated with one or more of Bio-therapeutic Drug Substance, Drug Product as well as Cell & Gene Therapy.

• Can resolve and negotiate conflicts or problems with tact, diplomacy and composure.

• Ability to handle multiple priorities with exceptional organizational and time management skills.

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.