Director of Manufacturing

San Antonio

Job Description Job Description 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 Vice President of Manufacturing Sciences, the Director, Manufacturing Sciences is responsible for providing leadership to the Scorpion Biomanufacturing organization ensuring safe and compliant manufacture of cGMP drug substance and drug product to meet client needs. This individual is a critical member of the Biomanufacturing team and will oversee all biologics cGMP clinical manufacturing activities including, technology transfer, upstream cell culture/fermentation, product recovery, downstream purification as well as provide CMC support for external clients. This individual will lead a team of engineers, scientists, and associates to manufacture and characterize high quality biologics in a highly interdisciplinary environment and be expected to communicate effectively and productively with the Process Development group, Facilities, Quality Assurance, Regulatory CMC group and other cross-functional organizations such as preclinical, clinical, and translational sciences groups as needed to ensure the product quality expectations are achieved at Scorpius BioManufacturing..

An ideal candidate must have a strict attention to detail, high quality customer service skills and the ability to instill these qualities onto others on the team.

Key Responsibilities

Transfers and Introduces technology of cell therapy-based and therapeutic protein processes into manufacturing collaborating extensively with Scorpion’s Process Development group to develop cGMP-compliant, clinical-scale production processes.

Plan and deliver cGMP Bulk Drug Substance and Final Drug Product to meet client and business needs.

Provide leadership and management of the Manufacturing Operations and Manufacturing Sciences and Technology functions continually implementing “state-of-the-art” technology for the manufacture of biologics products.

As a member of the Site Leadership Team, provide support, resources, and direction to implement site improvement activities.

Work with leadership peers to ensure support structures and resources are in place to continuously develop and retain Operations departmental staff.

Drive the highest of standards to showcase the facility, ensure cGMP compliance and provide a safety-first culture.

Effectively communicates results of departmental work through team discussions, written reports, and presentations.

Interacts with sales/marketing/business development team, as well as clients on, showcasing Scorpion capabilities, technical presentations, and project results.

Will also work closely with prospective new clients, as well as existing clients, to provide proposals, cost analysis and statements of work for manufacturing campaigns.

Education and Experience

B.S. in Engineering or Science discipline and 12+ years of cGMP biologic process development and manufacturing experience

M.S. in Engineering or Science discipline and 10+ years of cGMP biologic process development and manufacturing experience.

Experience in both upstream and downstream processing of both cell therapy-based and protein therapeutics is desirable.

Process development and manufacturing experience includes mammalian and/or microbial cell culture and scale up, the isolation and purification of proteins, antibodies, etc., extensive experience with product recovery (depth filtration, centrifugation, MF), TFF (UF/DF), chromatography (Affinity, IonX, HPT, HIC).

Requires a strong background with 10+ in cGMP principles and Quality Management Systems.

Experience working in a GMP manufacturing environment is essential.

Knowledge and Skills

Ability to effectively communicate with all levels within the company and client organizations.

Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization.

Strong organizational skills.

Process Excellence/Six Sigma Greenbelt / Blackbelt certified with hands-on knowledge of DOE and statistical software for use in design of process development studies.

Strong change management skills, ability to influence others.

Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.

Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.

Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.

Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.

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.