Associate Director, Virology

Minaris•Philadelphia, PA

13d•Onsite

About The Position

Manages a Testing and/or Analytical Sciences Team operations and staff. Demonstrates leadership in a fast-paced setting and operates with minimal oversight and a clear understanding of business and regulatory demands. Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of biopharmaceutical manufacturing and testing. Possesses an excellent understanding of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Code of Federal Regulations (CFR), and/or Points to Consider (PTC) compliance requirements. Manages staff and other resources to address scientific, business, and regulatory needs effectively and in a timely manner. Interacts with internal and external customers and auditors as needed to provide support and address any comments/issues. Remains current regarding best practices and develops or modifies procedures to stay fully compliant with the evolving expectations of all stakeholders. Prepares protocols and standard operating procedures (SOPs), and reviews and/or approves documents as area management. Manages schedules and testing activities, departmental metrics file, and value stream projects. Communicates with Management, Quality Assurance, and others as appropriate. Participates in the development and implementation of validation plans and protocols.

Requirements

Laboratory experience
Technical and Scientific knowledge of biosafety and analytical assays
Knowledge of GDP and, and cGMP and/or cGLP preferred
Effective multi-tasking skill and time management required
Ability to evaluate technical data and record data accurately and legibly
Ability to understand and follow verbal and demonstrated instructions
Ability to clearly express and exchange ideas by means of verbal and written communication
Ability to work effectively as part of a team and exhibit effective interpersonal skills
Ability to work under limited supervision and to handle problems of a difficult nature
Proficient in oral and written communication skills
Proficient in Microsoft (Excel, Word and Outlook)

Responsibilities

Prioritize and coordinate daily testing schedules, managing resource constraints, and directing analysts so workflows keep moving without bottlenecks.
Ensure testing and daily activities are scheduled, including training.
Aid in the training of new employees, perform classroom trainings, and serve as an assay trainer or departmental training coordinator.
Ensure lab upkeep per cGMP, CFR and/or PTC guidelines and SOPs.
Responsible for leading the on-time completion of client samples.
Supervise plans and review operations for the team, including training.
Recommend personnel actions and manage employee relations including performance reviews.
Recommend hire, transfers, promotions, discharge, or salary changes.
Act on employee issues.
Conduct employee performance reviews.
Contribute and support overall operations to achieve departmental goals.
Author quality events and Quality Actions as needed.
Author Test Methods, Client Protocols, SOPs, etc. as needed.
Perform Technical Review of executed testing records to ensure documents are accurate and complete.
Act as a liaison for client meetings.
Department metric management, and value stream management.
Understand the importance of regulatory compliance and comprehension of the laboratory assays.
Provide in-house guidance on science and technology.
Responsible for the Department P&L.
Directly involved in the decisions and/or activities to grow the business.
May be required to assist other departments.
Collaborate with other departments on projects.
Travel to visit clients or attend conferences.
Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Able to conduct basic to high complexity assays and lab procedures as outlined in testing records and regulatory guidelines with data analysis.
With appropriate training, perform other duties as assigned by supervisor or manager.
Embody Minaris Advanced Therapies values and align daily actions with department and company culture.