Associate Director, Molecular & Biology

Minaris Advanced Therapies•Philadelphia, PA

16h•$150,000 - $170,000

About The Position

The Associate Director, Molecular & Biology manages the Molecular Biology Testing Team’s operations and staff. The role provides scientific and supervisory leadership in a fast-paced environment, with minimal oversight, and applies knowledge of biopharmaceutical manufacturing and testing and regulatory requirements, including cGMP, GLP, CFR, and PTC compliance. The Associate Director manages staff and resources to meet scientific, business, and regulatory needs; interacts with internal and external customers and auditors; maintains and updates procedures; prepares and reviews or approves protocols, SOPs, and other documents; manages schedules, testing activities, departmental metrics, and value stream projects; and works with Management, Quality Assurance, and other departments. The role also participates in developing and implementing validation plans and protocols. The ideal candidate has expertise in molecular biology, NGS assay development, regulated testing, CRO operations, and bioinformatics pipeline implementation. The role supports development and validation of next-generation sequencing testing in a regulated CRO environment and oversees scientific strategy, laboratory workflow development, bioinformatics implementation, GMP-compliant testing processes, and client-facing technical support. It partners closely with Quality, IT, Business Development, and client teams. This position leads daily testing operations and staff, supports employee training and development, manages employee relations and performance reviews, and contributes to departmental goals and business growth. It is responsible for the department P&L and may require travel to visit clients or attend conferences. Regular, reliable full-time attendance is required.

Requirements

Bachelor’s degree in Biological Sciences or another science-related major, with 10 or more years of relevant or equivalent experience; alternatively, a master’s degree in Biological Sciences or another science-related major, with 8 or more years of relevant or equivalent experience.
Laboratory experience.
Technical and scientific knowledge of biosafety and analytical assays.
Effective multitasking and time-management skills.
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 verbally and in writing.
Ability to work effectively as part of a team and demonstrate effective interpersonal skills.
Ability to work under limited supervision and handle difficult problems.
Proficiency in oral and written communication.
Proficiency in Microsoft Excel, Word, and Outlook.
Experience with NGS and regulated molecular testing capability.
Demonstrated scientific and supervisory skills and practical knowledge of biopharmaceutical manufacturing and testing.
Strong understanding of cGMP, GLP, CFR, and/or PTC compliance requirements.
Expertise in molecular biology, NGS assay development, regulated testing, CRO operations, and bioinformatics pipeline implementation.
Experience supporting cell and gene therapy, biologics, and viral testing programs.
Ability to work in ambiguous situations and adapt to change.
Professional behavior with internal and external business associates, consistent with company policies and practices.

Nice To Haves

Knowledge of GDP, cGMP, and/or cGLP is preferred.
Familiarity with LIMS integration, computer system validation, laboratory automation, cloud data analysis environments, and secure data transfer.
Prior responsibility for staffing, budgeting, vendor selection, platform implementation, and commercial service development.

Responsibilities

Prioritize and coordinate daily testing schedules, manage resource constraints, and direct analysts to keep workflows moving without bottlenecks.
Ensure testing and daily activities, including training, are scheduled.
Assist in training new employees, conduct classroom training, and serve as an assay trainer or departmental training coordinator.
Ensure laboratory upkeep in accordance with cGMP, CFR and/or PTC guidelines, and SOPs.
Lead the on-time completion of client samples.
Supervise and review team operations, including training plans.
Recommend personnel actions and manage employee relations, including performance reviews.
Recommend hiring, transfers, promotions, discharge, or salary changes, and act on employee issues.
Conduct employee performance reviews.
Contribute to overall operations and achievement of departmental goals.
Author quality events and Quality Actions as needed.
Author test methods, client protocols, SOPs, and other documents as needed.
Technically review executed testing records to ensure documents are accurate and complete.
Act as a liaison for client meetings.
Manage departmental metrics and value stream activities.
Apply understanding of regulatory compliance and laboratory assays.
Provide in-house guidance on science and technology.
Manage departmental P&L and participate in decisions and activities to grow the business.
Assist other departments as required and collaborate across departments on projects.
Travel to visit clients or attend conferences.
Support a diverse and inclusive culture and workforce and ensure compliance with laws, regulations, and company policies.
Identify, recruit, and retain talent; set performance standards; encourage engagement through delegation, feedback, goal setting, and performance management; and develop employees toward career and organizational goals.
Build customer relationships and deliver customer-centric solutions.
Communicate organizational information through department and one-on-one meetings, email, and regular interpersonal communication.
Model ethical behavior, maintain confidential information, and demonstrate autonomy and sound decision-making.
Perform other duties as assigned.