TITLE: Manufacturing Coordinator III

REPORTS TO: Manager, GMP Services

LOCATION: San Antonio, Texas (On-site)

The Company

Velocity Bioworks is a U.S.-based biopharma CDMO headquartered in San Antonio, Texas supporting funded programs as they move from development into manufacturing for clinical trials. We collaborate with sponsors who are past exploration and are ready to apply discipline, structure, and technical rigor to development, analytics, and manufacturing.

Velocity is built to accelerate speed to clinic through aligned execution. Our work focuses on translating defined program goals into scalable manufacturing processes and robust analytical strategies. These activities are designed to support near-term clinical timelines while meeting quality requirements. We operate where quality and execution directly influence clinical and business progress.

Position Summary

Reporting directly to the GMP Services Manager, the Manufacturing Coordinator III will be responsible for supporting the manufacturing team to execute a high-quality manufacturing process driven by collaboration and right the first-time mindset. Primary responsibilities include coordinating and assuring the execution of readiness tasks to maintain schedule adherence and support successful batch completion and project reports. The Manufacturing Coordinator III position requires scheduling proficiency, develop and review GMP documents, support deviations and investigations, implement CAPAs, and Change Controls management. An ideal candidate must have experience in GMP manufacturing environments, planning skills, activities coordination and tasks prioritization. Must have strict attention to detail, high-quality customer service skills, and the ability to work well independently and in collaboration with cross-functional teams at Velocity Bioworks.

Key Responsibilities

• Coordinate Manufacturing Schedule and plan support activities for both microbial and mammalian manufacturing facilities.
• Lead deviations and investigations, support root cause analysis, collaborate with Change Controls development and implementation, and support CAPA’s resolution with SME and quality teams.
• Draft and review Manufacturing Batch Records, SOPs, logbooks, forms and any applicable documents on time for manufacturing staff training activities and manufacturing process execution.
• Plan activities: Create manufacturing, cleaning, training, equipment calibration and maintenance schedules and track adherence.
• Review of manufacturing sample plans.
• Review manufacturing process descriptions for manufacturing process.
• Collaborate with Project Management to ensure adherence to client timelines and reporting to site leadership team.
• Support readiness activities for manufacturing teams for mammalian and microbial manufacturing programs, actively participate in tech transfer process from Process Sciences to manufacturing.
• Work in collaboration with Process Development, Quality Control, Quality Assurance, Manufacturing, Supply Chain, and Facilities to ensure all support groups are aligned with the requirements of the manufacturing process.
• Support Facilities and QA Equipment and Validation in ensuring equipment functionality and readiness. Coordinate calibration and preventive maintenance scheduling and track adherence to maintenance timelines.
• Submit work requests for new services or changes and ensure their completion according to manufacturing campaign timelines.
• Effectively communicates safety equipment requirements, project objectives, and concerns, while ensuring team compliance with mitigation measures and facility safety policies.
• Maintain company and client confidentiality.

Education & Experience

Candidate shall have education, training, and experience, or any combination thereof.

• Experience working in a GMP manufacturing environment is essential.
• Knowledge and experience with gowning practices and clean room behavior.
• Manufacturing processes in microbial or mammalian systems with knowledge of upstream or downstream processes is highly desirable.
• Requires a strong background in CGMP and GDP principles and experience handling Quality Management Systems Operation.
• Requires combination of years of working experience in GMP environment in addition to an HSD/GED, Associate’s, BS, or MS from an accredited college or university with major coursework in a Scientific or Engineering discipline.
• High School Diploma or GED and 10+ years of biomanufacturing experience (GMP).
• Associate degree (AS) and 8+ years of biomanufacturing experience (GMP).
• Bachelor’s degree (BS) and 6+ years of biomanufacturing experience (GMP).
• Master’s degree (MS) and 4+ years of biomanufacturing experience (GMP).

Knowledge & Skills

• Communication skills:
• 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, suppliers and customers.
• Strong listening skills to understand staff concerns or operational issues.
• Outstanding interpersonal skills: ability to build strong working relationships with cross-functional team members and upper management and lead through influence.
• Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor.
• Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, PowerPoint, and Project.
• Must maintain a working knowledge of commercial CGMP’s and phase-appropriate CGMP’s as they apply to various phases of clinical and commercial manufacturing.
• Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.
• Perform with accountability and integrity: Owns decisions and outcomes. Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.

Physical Requirements & 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.
• Must meet gowning requirements for cleanroom Grade A/ISO 5 environments.
• Must be able to be fully gowned in cleanroom attire and be able to stand for an extended time.
• Some essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate.
• Job execution may require the employee to sit, stand up and walk during prolonged periods
• Reach with hands and arms and to talk and/or hear.
• Lift and/or move up to 20 pounds may be part of the process tasks.
• Vision acuity is required, including close vision, distance vision, color vision, and the ability to adjust focus.
• Manual dexterity and manual ability to effectively use computer terminals are required.

Notice to Third Party Agencies: Velocity Bioworks does not accept unsolicited resumes from recruiters or employment agencies. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement and approved engagement request with Velocity Bioworks, Velocity Bioworks reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Velocity Bioworks is proud to be an EEO/AAP Employer. Velocity Bioworks encourages protected veterans, individuals with disabilities, and applicants from all backgrounds to apply. Velocity Bioworks ensures nondiscrimination in all programs and activities in accordance with Title VI of the Civil Rights Act.