What are the responsibilities and job description for the Manufacturing Supervisor, Downstream position at TANVEX BIOPHARMA USA INC?
Job Description
Job Description
Description : SUMMARY
Under general guidance, Supervisor will supervise and perform downstream unit operations in clinical and commercial GMP manufacturing setting. Roles and responsibilities include ownership of GMP facility, production planning, downstream manufacturing processes including chromatography, UF / DF and filtration steps, GMP training metrics, and improvement projects.. The supervisor will oversee the downstream team to ensure production and associated downstream activities are delivered on time. Supervisor will ensure all SOPs and batch records associated to scope of work are up to date and meet the cGMP standard.
JOB RESPONSIBILITIES
Essential Functions
Staff Management
Responsible for staff and functional area performance
Responsible for recruiting, selection, hiring, training, performance evaluation and development of staff
Coach, mentor, and grow upstream team member
Ensure the quality of training programs for staff
Assist management team for optimizing organizational structure and responsibilities
Technical
Will supervise and perform downstream unit operations in clinical and commercial GMP manufacturing setting by
Overseeing downstream cGMP clinical and commercial manufacturing
Managing and planning staff shift coverage as needed
Ensuring the in-department inventory is sufficiently controlled and available
Ensuring the production schedule is planned and executed on time
Ensuring the downstream manufacturing team meets the targeted success rate
Ensuring the safety of the working environment
Developing, implementing and providing solutions for complex manufacturing problems
Collaborates with cross-functional teams i.e. QA, QC, materials management, engineering, facility, product research and development, project management.
Accurately completes, reviews and maintains detail-oriented documentation of equipment logs, cleaning logs and batch records following the good manufacturing documentation practices.
Ensures cGMP and 21CFR compliance of operating areas
Manages the development and revision of SOPs and batch records
Acts as subject matter expert for production support during audits and investigations
JOB REQUIREMENTS
Education : & Experience
B.S in engineering or science with 9 years or M.S. with 6 years of relevant biotech / pharmaceutical industry experience or a minimum of high school diploma / GED and 12 years of Manufacturing and Operations experience
Fundamental knowledge of current biologics regulations and cGMP for drug substance operation are required.
Experience with cGMP manufacturing and quality systems for biologics products required
Minimum of 2 years of manufacturing related managerial experience required
Production planning experience preferred
Knowledge, Skills & Abilities
Candidate must be a strong team player and have the ability to collaborate cross functionally.
Strong technical writing skills and presentation skills are preferred
Knowledge and experience of working with cross-functional team and managing deviations, incidents, CAPAs, and CCRs
Proficient with Microsoft Word, Excel, PowerPoint
Strong technical writing and presentation skills preferred.
Ability to communicate in highly collaborative environment and work flexibly is essential.
Strong problem-solving ability preferred
Ability to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
Demonstrate the extensive knowledge and experience in biologics cGMP manufacturing
Demonstrate technical mastery of related downstream manufacturing process and associated analytical equipment
WORK ENVIRONMENT / PHYSICAL DEMANDS / SAFETY CONSIDERATIONS
Required to spend up to 25% of their time working in a standard office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets.
Regularly required to talk and hear; to exchange ideas accurately, loudly or quickly through oral communication. Specific vision requirements include close vision, distance vision, peripheral vision, depth perception, color vision and ability to adjust focus. The noise level in the work environment is usually quiet to moderate.
Required to perform repetitive tasks such as typing, use of mouse and pipetting. Consistently required to perform sitting, standing for sustained periods of time, reaching, twisting, handling, fingering, and feeling objects such as tools and controls. Frequently required to climb stairs, ramps and step ladders. Occasionally involves stooping, balancing, kneeling, crouching and feeling.
Must frequently exert up to 10 pounds of force and occasionally up to 75 pounds of force to push, pull, lift or otherwise move objects.
Required to work within the manufacturing facility and must be able to gown appropriately and don required personal clothing to enter controlled manufacturing facility including sterile environments. Employee is required to wear protective eyewear, Tyvek suit, nitrile gloves (double glove) and safety shoes.
Employee is required to work within the manufacturing facility where large amounts of bio culture are present. The cell lines are risk group 1 agents.Employee will potentially be exposed to active pharmaceutical ingredients. (e.g. kanamycin)
May be occasionally exposed to thermal hazards such as liquid nitrogen and hot vessels.
May be exposed to hazardous chemicals which may pose a health and physical hazard (e.g. corrosive, toxic, reactive, etc.).
Required to work with sharps contaminated with chemicals which may pose a percutaneous hazard.
May be exposed to one or more of the following conditions which may affect their respiratory system : dusts, fumes, odors, vapors or mists.
Must be able to work flexible hours. May need to work overtime, on weekends or nights, or on-call as needed. Available to work a split shift when the process requires.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions for this position.
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