Execute technical support activities for GMP Manufacturing Operations in a multi-product, Fill/Finish CMO facility including activities related to compliance, quality, targeted innovation, and plant performance and success.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Lead or execute implementation of targeted new technologies and procedures.
- Assess, evaluate and provide immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis and reporting.
- Serve as first line of defense for all manufacturing excursions, GMP lifecycle management of execution level process data, providing for unit operation (formulation, sterile filling, inspection/labeling).
- Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error.
- Support strategic plans for process and plant improvements in order to increase efficiency and manage costs.
- Work with Tech Transfer teams to transition products through the product development timeline.
- Implement and review operational documentation systems within Manufacturing, Operations and Process Development. Main responsibilities include authoring and implementation of manufacturing procedures and batch records. Drafting SOPs, addressing comments, incorporating edits and issuing final drafts for approval.
- Effectively collaborate with other team members, production operators, engineers, microbiologists, analytical chemists, and senior management.
- Assist engineering and validation with implementation, commissioning, and validation of clean room spaces and process equipment.
- Take corrective action by thinking creatively, problem solve, and develop innovative solutions based on sound scientific analysis.
- Participate in client communications, including problem solving, schedule development, and project status updates as required.
- Initiate revisions to cGMP procedures, and master batch records as applicable.
- Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
- 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 AND ABILITIES
- Available for off-shift and/or on-call work, as needed.
- Independent worker and proven self-starter.
- Detail oriented.
- Professional and positive approach.
- 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; Acts with a sense of urgency.
- Creative and open-minded individual 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 independently and in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
EDUCATION AND PRIOR EXPERIENCE
- Bachelor's degree in life sciences or equivalent training and/or experience is necessary.
- Two to five (3-5) years of relevant experience in pharmaceutical manufacturing or a laboratory environment is required
- Previous experience in a CMO and/or sterile pharmaceutical manufacturing preferred.
GRAM supports Equal Opportunity Employment