Manages a Testing and/or Analytical Sciences Team operations and staff. Demonstrate 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. 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. Manage staff and other resources to address scientific, business and regulatory needs in an effective and 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 expectation of all stakeholders. Prepares protocols and standard operating procedures (SOPs), and reviews and/or approves documents as area management. Manages the schedules and testing activities, departmental metrics file and value stream projects. Communicate with Management, Quality Assurance, and other as appropriate. Participates in development and implementation of validation plans and protocols.

Essential Functions and 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 schedule, including training
• Aids in the training of new employees, perform classroom trainings, and serves 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
• Supervises plans and review operations for the team, including training
• Recommends personnel actions and manages employee relations including performance reviews
• Recommends hire, transfers, promotions, discharge, or salary changes. Acts on employee issues
• Conducts employee performance review
• Contributes and support to the overall operations to achieve departmental goals
• Authors 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
• Understands the importance of the regulatory compliance and comprehension of the laboratory assays.
• Provide in-house guidance on science and technology
• Receives minimal instruction on routine work and on new assignments
• 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 record and regulatory guidelines with data analysis

• With appropriate training perform other duties as assigned by supervisor or manager

• Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture

Knowledge, Skill & Ability

• 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)

Education & Experience

• Bachelors' degree in Biological Sciences, or other science related major, with 10+ years of relevant or equivalent experience
• Master's degree with major in Biological Sciences, or other science related major, with 8+ years of relevant or equivalent experience
• PhD in Biological Sciences, or other science related major, with 6+ years of relevant or equivalent experience

The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual's qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.