Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (
GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Position Summary
Provides technical and administrative managerial leadership to the Steriles Technical Support group by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Job Overview
- Manages technical resources by appropriately budgeting and hiring to meet operational needs. Manages the administrative aspects of the group by ensuring the preparation of performance plans, job descriptions, and conducting employee performance reviews.
- Manages all work commitments with production personnel. Provides guidance to staff in technical and management issues. Ensures proper response and methods are used on all situations that may occur.
- Ensures department directives are met and customer project timelines and goals are on target.
- Supports development and implementation of strategic plans that will grow the business with existing customers and potential new customers.
- Provides resources to identify and execute the activities necessary to accomplish process technology transfer of new products to the division. Provides leadership and technical expertise in the development of the manufacturing relationship with outside clients and facilitating the technology transfer process.
- Drives on time completion of Deviations, Correct Action Plans (CAPA’s), Work Order Updates, Standard Operating Procedures (SOP) Revisions, Audit Responses.
- Assesses technical responses to questions/issues raised by regulatory agencies (e.g., FDA and USP). Serves as a subject matter expert for sterile operations.
Qualifications:
- Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.
- Three (3) years of leadership/supervisory experience.
- Five (5) years of dynamic experience within Sterile Pharmaceutical environment.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- Knowledge in GMP’s and FDA regulations.
- Strong decision making skills.
- Highly effective verbal and technical written communication skills and the ability to negotiate a diversity of issues.
- Excellent interpersonal skills to establish and maintain effective working relationships with employees.
- Ability to resolve issues independently, and to engage others as needed in a productive / constructive manner.
- Comprehensive knowledge of sterile production operations. Experience working on broad multidisciplinary teams and/or groups.
- Outstanding attention to detail. Self-starter, mature, and independent.
- Strong computer/ software skills (i.e. Outlook, Excel, Word, PowerPoint).