Strong technical writing and project planning skills
Proficient in Microsoft Excel and Word; Access is a plus
Responsibilities
Oversee laboratory personnel and equipment operations
Create training programs for team members
Guide troubleshooting and investigations of deviations
Develop short and long-term strategic plans
Manage the budget for the department
Ensure compliance with safety regulations
Conduct performance appraisals and facilitate career development
Participate in customer and regulatory audits
Interface with various departments to resolve operational issues
Proactively manage risks in raw material and microbiology processes
Communicate quality and compliance requirements to the team
Approve method validation and technical reports
Benefits
Opportunities for professional development and training
Collaborative work environment
Engagement in strategic planning and decision-making
Involvement in customer and regulatory audits
Supportive team culture focused on quality and compliance
Full Job Description
Position
Manager, Raw Materials and Microbiology
Location
Vandalia, Ohio
Summary
The Manager, Raw Materials and Microbiology is an essential part of the Site Quality team, and is responsible for the management of daily activities for the Raw Materials and Microbiology group. The Manager will be expected to coach and mentor Raw Material Chemists and Microbiologists, provide input on resourcing, and prioritize tasks needed for the team to meet the established project timelines.
Responsibilities
Responsible for the operation of the personnel and equipment in the laboratory. This includes personnel scheduling and ensuring all laboratory equipment is properly calibrated and functioning properly.
Creates training curriculum for staff member to ensure the team is properly trained.
Guides team in troubleshooting and completing investigations and any significant deviations and/or OOS/OOT results.
Develops short and long term strategic plans
Develops and manages the budget.
Ensures the team complies with all safety regulations.
Responsible for performance appraisals of members of the group and for facilitating the career development of the team members through training, mentoring, etc.
Reduces non-conformities and non-value added processes.
Participates in customer and regulatory audits.
Interfaces with Operations, Supply Chain, Technical Services, R&D and Regulatory Affairs to provide support as needed and assist with identification and resolution of problems related to Adare operations.
Proactively manage and mitigate risk across the raw material and microbiology processes.
Communicates customer, regulatory and organizational requirements to the team to assure product quality, compliance, and customer satisfaction
Understands, follows and enforces all established safety, health, quality GMP and Company policies, procedures and practices.
Approves method validation and verification testing on new products and raw materials for the Microbiology Lab.
Responsible for the approval of technical reports and other documents necessary for the completion of project goals and product compliance.
Other duties as required.
Experience, Education, and Skills Required
Minimum Bachelors degree in Analytical Chemistry or related scientific field.
8+ years experience in the Pharmaceutical industry, at least 5 years related to quality.
Previous experience directly managing teams.
Hands-on experience required performing the following types of testing: Wet chemistry, HPLC analysis, GC analysis, UV analysis, titrations
The ability to evaluate results of HPLC, GC, UV, IR and wet chemistry techniques as applicable to a pharmaceutical lab environment
Working knowledge of USP, EP, and JP procedures
Understanding of proper aseptic technique
Experience in reviewing and auditing Laboratory documentation required.
Computer skills regarding use and application of Microsoft Excel and Word required, Microsoft Access a plus
Strong technical writing skills, as well as organizational and project planning skills are required.
Interfaces with research and development personnel, manufacturing, quality control, customers, government agencies, and outside vendors and suppliers.
Confidentiality of projects, tests results and both customer and Company information and data is required.
