JOB TITLE - MANUFACTURING SUPERVISOR
JOB SUMMARY - Manage routine manufacturing tasks under the guidelines of established procedures and cGMP regulations under guidance of senior management and provide leadership to other employees.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Manage routine manufacturing activities; including day to day scheduling and raw materials/consumables management.
- Provide leadership when performing component and equipment preparation, bulk drug formulation, aseptic formulation, and aseptic filling duties as needed.
- Accurately document data and complete batch records as needed.
- Successfully complete facility’s gowning and manufacturing qualification program.
- Perform and train other employees in various manufacturing tasks, including, but not limited to: fill/finish, lyophilization, gowning, sanitization, and component and equipment preparation activities.
- Operate production equipment.
- Perform and assist in the development of formulation activities.
- Perform duties in ISO 4.8 and ISO 7 cleanrooms.
- Execute and author well-defined procedures and assist other technical personnel on issues and problems.
- Initiate revisions to cGMP/procedure guidelines.
- Assist in the scheduling and performance of routine maintenance of production equipment.
- Oversee operations of the production areas, including the warehouse and utility areas.
- Participate in client communications, including problem solving, schedule development, and project status updates.
- Perform routine performance assessments with direct reports.
- Define and uphold disciplinary actions for poor performance of direct reports, as necessary.
- Foster a positive team environment that promotes productivity and employee satisfaction
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
EDUCATION, PRIOR EXPERIENCE, AND TRAINING
- Bachelor’s degree in life sciences or equivalent training and/or experience is necessary.
- Two to five (2-5) years of relevant experience in pharmaceutical manufacturing or a laboratory environment is required.
- Proven self-starter.
- Available for off-shift and/or on-call work, as needed.
DESIRED SKILLS AND ABILITIES
- Prior GMP sterile manufacturing experience preferred.
- Professional and positive approach.
- Proven leadership skills.
- Ability to follow procedures and regulatory guidance documents.
- Strong in building relationships and able to communicate at all levels.
- Team player, and able to work on own initiative.
- Proficiency in both written and verbal communication and presentations.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Ability to work closely with a diverse customer base (internally and externally).
- Ability to work well in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
WORKING CONDITIONS & PHYSICAL DEMANDS
INTERNAL – Work is normally performed in a cleanroom environment that is both temperature and humidity controlled. Personnel is required to wear company owned garments that serve to protect the cleanroom environment. These garments include scrubs and dedicated cleanroom shoes in addition to disposable coveralls, shoe covers, face masks, hoods, and gloves. Qualification for aseptic gowning and aseptic operator by successful media fill participation is necessary to deem personnel as a fully qualified operator. Noise within the cleanroom is below levels that require ear protection, but ear protection is provided for the comfort of the operator. Qualification for use of a full-face respirator is required for working with hazardous chemicals during chemical dispense and addition activities. Personnel is trained on safety for each piece of equipment that poses a potential hazard.
Work outside of the cleanroom is minimal and is performed in a climate controlled office where exposure to conditions of extreme temperature, poor ventilation, fumes and gases is very limited. Noise level is moderate and includes sounds of office equipment. No known environmental hazards are encountered in normal performance of job duties when outside of the cleanroom environment.
GENERAL – Work involves standing and walking for extended periods of time, as most duties are performed from standing position. Work may include occasional pushing, pulling or carrying objects weighing up to 50 pounds. Work requires finger dexterity and eye-hand coordination.
The above description is a broad overview of this position and not all duties may be clearly pre-defined. From time-to-time, various projects may require more or less attention than described. If it is decided in the future that some tasks are better served in another department, by outsourcing, or due to technological developments, these duties may be subject to revision. In any event, this job description is in no way considered a contract of employment or an altering of the employment at-will relationship.