Downstream Supervisor, Manufacturing

Velocity Bioworks•San Antonio, TX

3d•Onsite

About The Position

Reporting directly to the Manufacturing Manager, the Downstream Supervisor will be responsible for overseeing daily operations related to downstream processing in a CGMP-compliant biologics environment. An ideal candidate must have strong experience in downstream manufacturing, process execution, and the operation of qualified scaled equipment. Strong understanding of Good Manufacturing Practices (CGMP) and Regulatory Guidelines, strict attention to detail, high-quality customer service skills, sound judgment and ability to escalate issues appropriately, and the ability to work well and collaborate in cross-functional teams at Velocity Bioworks.

Requirements

Associate’s, BS, MS, Ph.D. from an accredited college or university with major coursework in a Scientific or Engineering discipline preferred.
Ph.D. with 0-2 years, Master’s with 4+ years, Bachelor’s Degree with 6+ years or Associate’s with 8+ years of experience within related discipline and track record of success.
Experience working in a GMP manufacturing environment is essential.
Manufacturing processes in downstream microbial systems is highly desirable.
Requires a strong background in CGMP and GDP principles and experience handling Quality Management Systems.
Must demonstrate proper writing and PC skills with a knowledge base in Microsoft Office Suite.
Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.
Must maintain a working knowledge of commercial and phase-appropriate cGMP’s as they apply to various phases of clinical and commercial manufacturing.
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.
Proven ability to communicate, engage and coordinate with external vendors and suppliers to ensure timely delivery of materials and services.
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.
Strong listening skills to understand staff concerns or operational issues.
Critical and analytical thinking, good judgment and ethics, professional presence, interdepartmental collaboration, and demeanor.
Must meet gowning requirements for cleanroom Grade A/ISO 5 environments and pass PAPR physical requirements.
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.

Nice To Haves

Manufacturing processes in downstream microbial systems is highly desirable.

Responsibilities

Responsible for supervising daily manufacturing activities.
Responsible for setting manufacturing schedules and timelines and ensure adherence by manufacturing team.
Responsible for authoring and reviewing batch records and other CGMP documentation.
Accountable for time and resources management.
Managing shift operations, prioritizing tasks, strategic resources allocation, delegating tasks effectively to assure schedule adherence.
Capable of motivating, coaching, and leading a team in a fast-paced, regulated environment.
Leads by example, especially regarding GMP compliance and safety.
Responsible for hiring, onboarding, training, and performance evaluations.
Ensure team execution is logged in NetSuite program.
Ensure manufacturing execution is in compliance with equipment calibration and preventive maintenance.
Responsible for implementing continuous improvement methodologies.
Encourages team suggestions for process improvement and error reduction.
Operate bench-scale to large-scale chromatography (AKTA) systems.
Operate bench-scale to large-scale filtration systems including tangential flow filtration (TFF) and depth filtration (DF).
Expert in Unicorn software for programming and control of chromatography (AKTA Pilot and AKTA Ready) and filtration (AKTA Ready Flux) systems.
Large-scale column packing and evaluation.
Single-use mixing and centrifugation systems (continuous and bucket)
Bulk fill and aseptic handling techniques
Filter use, handling, and filter integrity testing (FIT) with troubleshooting experience
Drive proactive troubleshooting among staff, encouraging equipment and processes SMEs development.
Maintain company and client confidentiality.
Responsible for meticulous and accurate review of executed production records for proper GDP and execution of production activities within established timelines.
Active collaboration with Change Controls, Risk Assessments, and Deviations Management, Investigation Tools (5 Why's, Fishbone Diagram, etc.) and CAPA Implementation in association with SMEs and QA team.
Communicate safety policies and goals and ensure team members adhere to facility safety policies.
Ability to track and interpret manufacturing performance data and use metrics to drive improvements.
Provide input and feedback to the Process Sciences/Technical Transfer team during development and scale-up.
Ability to coordinate activities with QA, QC, Process Sciences, Facilities, GMP Services, and Supply Chain teams.