Overview

The work we do at FDB has never been more important and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.

Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities.

Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations.

This individual will supervise a team of employees directly or indirectly in these production process units.

Reports to Manager / Senior Manager, Manufacturing

Work Location College Station, TX

Primary Responsibilities :

• Operational oversight of the following systems dependent upon assignment.
• Downstream Unit : Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF).Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration.

Medium to Large-scale Chromatographic systems (ÄKTA).Pre-Packed Columns from 1L to 100L.Single use mixing systems (Pall & GE).

Single Use connectivity types such as GE DAC and Colder AseptiQuik.Plate counting, microscopic examination.Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation.

Bulk filling.Aseptic process simulation and drug product filling.

• Responsible for supervising daily manufacturing activities and staff, including hiring, performance, evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc.
• Responsible for implementing project safety and quality assurance programs.
• Execution of SAP functionality for batch close out and generating SAP reports as required.
• Develop, write, and review Standard Operating Procedures, Buffer Formulation Records and Batch Production Records (BPRs).
• Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations.
• Lead deviation resolution and closure with subject matter expert and quality teams.
• Responsible for tracking CAPAs to closure.
• Provide input and support to R&D functions during development and scale up activities as necessary.
• Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes.
• Ensure an adequate supply of materials available; ensure all materials for project are procured prior to production.
• Maintain the confidentiality of proprietary company information.
• Responsible for continuous improvement in areas of responsibility.
• Maintain an effective working relationship with others.
• Perform all other duties as assigned.

Qualifications :

• Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field and 3 years of experience in a manufacturing environment; OR
• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field and 5 years of experience in a manufacturing environment; OR
• Associate’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 7 years of relevant experience; OR
• High School / GED and 9 years of relevant experience.
• Previous experience in a leadership or supervisory role required.
• 3 years of experience in a GMP environment required.
• Biotechnology Certificate preferred.
• Green-Belt Certification preferred.
• Experience with mammalian, insect, yeast, or bacterial cell lines and their cultivation and / or purification of biologics or viral vectors produced from such preferred.
• Demonstrated leadership, coaching and mentoring skills.
• Demonstrated experience in training others to perform and maintain cGMP standards.
• Excellent skills with Microsoft Office applications.
• Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required.
• Excellent self-discipline and attention to detail.
• Advanced math and computer skills.
• Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities.
• Demonstrated ability to work with teams and collaborate with others.
• Excellent problem-solving skills.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Physical Requirements :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to :

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
• Ability to lift / pull / push up to 25 pounds frequently and up to 50 pounds on occasion.
• Attendance is mandatory.

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.

We are a company of emboldened goal seekers driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

Last updated : 2024-04-23