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 resource 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 Grade C cleanrooms and Grade A isolators.
- 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.
DESIRED SKILLS & 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.
Qualified candidates have a Bachelor’s degree in life sciences or equivalent training and/or experience. Two to five (2-5) years of relevant experience in pharmaceutical manufacturing or a laboratory environment is required. Previous leadership preferred. Available for off-shift and/or on-call work, as needed.