SUMMARY
Under general guidance, the manager will supervise and perform downstream GMP manufacturing operations including chromatography, UF/DF and filtration steps. The manager will schedule and oversee the daily manufacturing activities in the responsible areas to ensure production and associated supporting activities are delivered in time. Manager will ensure all SOPs and batch records associated with the scope of work are current and meet the cGMP standard. Candidate must be a strong leader and team player and possess ability to collaborate cross functionally. Fundamental knowledge of current biologics regulations and cGMP for drug substance operations is required.
JOB RESPONSIBILITIES
Staff Management
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Responsible for staff and functional area performance
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Responsible for recruiting, selection, hiring, training, performance evaluation and development of staff
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Coach, mentor, and grow staff and downstream team
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Ensure the quality of training programs for staff
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Propose to management team for optimizing organizational structure and responsibilities
Technical
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Demonstrate the extensive knowledge and experience in biologics cGMP manufacturing
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Demonstrate technical mastery of related downstream manufacturing process and associated analytical equipment
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Strong technical writing skills and presentation skills are preferred
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Oversees downstream cGMP clinical and commercial manufacturing
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Manages and plans staff shift coverage when needed
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Ensure the in-department inventory sufficiently controlled
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Ensure the production schedule is planned and executed on time
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Ensure downstream manufacturing team meets the targeted success rate
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Ensure the safety of working environment
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Develop, implement and provide solutions for complex manufacturing problems
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Collaboration with cross-functional teams i.e. QA, QC, materials management, engineering, facility, product research and development, project management
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Accurately complete, review and maintain detail-oriented documentation of equipment logs, cleaning logs and batch records following the good manufacturing documentation practices.
Compliance
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Initiate/lead/review/approve manufacturing related deviations, incident reports, investigation reports, CAPAs, change controls, technical reports, and validation protocols
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Ensure cGMP and 21CFR compliance of operating areas
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Manage the development and revision of SOPs and batch records
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Act as subject matter expert during audits and investigations
JOB REQUIREMENTS
Education:
Experience:
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Experience with cGMP manufacturing and quality systems for biologics products required
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Minimum of 2 years of manufacturing related managerial experience required
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Knowledge and experience of working with cross-functional team and managing deviations, incidents, CAPAs, and CCRs
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Proficient with Microsoft Word, Excel, PowerPoint
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Strong technical writing and presentation skills preferred.
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Ability to communicate in highly collaborative environment and work flexibly is essential.
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Strong problem-solving ability preferred
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Ability to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
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Production planning experience preferred
WORK ENVIRONMENT/PHYSICAL DEMANDS/SAFETY CONSIDERATIONS
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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.
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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.
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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.
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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.
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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.
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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)
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May be occasionally exposed to thermal hazards such as liquid nitrogen and hot vessels.
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May be exposed to hazardous chemicals which may pose a health and physical hazard (e.g. corrosive, toxic, reactive, etc.).
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Required to work with sharps contaminated with chemicals which may pose a percutaneous hazard.
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May be exposed to one or more of the following conditions which may affect their respiratory system: dusts, fumes, odors, vapors or mists.
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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.
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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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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