Associate Director, Molecular & Biology

Position Summary
Manages the Molecular Biology Testing 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. 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. The ideal candidate will have deep expertise in molecular biology, NGS assay development, regulated testing, CRO operations, and bioinformatics pipeline implementation. This individual will partner closely with Quality, IT, Business Development, and client teams. The candidate will support the development and validation of next-generation sequencing testing offering within a regulated CRO environment. This role will oversee scientific strategy, laboratory workflow development, bioinformatics implementation, GMP-compliant testing processes, and client-facing technical support.
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.
• Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
• Other duties as assigned.
Leadership Responsibility:
• Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
• Identifies, recruits, and retains top-notch talent.
• Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
• Develop employees to meet both their career and organizational goals.
• Builds strong customer relationships and delivers customer-centric solutions.
• Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
• Comfortable working in ambiguous situations and adaptable to change.
• Must model the highest degree of moral and ethical behavior and maintain confidential information.
• High degree of autonomy and strong decision-making skills.
Knowledge, Skills & 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)
• Experience with NGS and regulated molecular testing capability.
• Familiarity with LIMS integration, computer system validation, laboratory automation, cloud data analysis environments, and secure data transfer.
• Experience supporting cell and gene therapy, biologics, and viral, testing programs.
• Prior responsibility for staffing, budgeting, vendor selection, platform implementation, and commercial service development.
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