Director, Advanced Therapeutics

JOB SUMMARY

The Director of Advanced Therapeutics will report directly to the Senior Director of Operations. This Director of Advanced Therapeutics will be responsible for the managing, developing and growing the day-to-day execution of client work in the advanced therapeutics laboratory which includes both Analytical Development and Large Molecule labs. This position is responsible for ensuring scheduled and prioritized work is completed to meet customer expectations. All work is performed in compliance with the quality, health and safety objectives of the company. This position provides technical support to advanced therapeutic scientists.

PRIMARY DUTIES AND RESPONSIBILITIES

• Oversee the development, characterization, and scale-up of large molecule processes, including upstream and downstream operations.
• Collaborate with cross-functional teams to develop and optimize analytical methods for large molecule characterization (e.g., HPLC, LC-MS, ELISA).
• Foster a collaborative and innovative work environment focused on achieving project goals.
• Stay updated on industry trends and advancements in large molecule technologies.
• Drive process improvements and implement new technologies to enhance productivity and quality.
• Manage Client timelines and budgets for large molecule and Analytical Development programs, ensuring deliverables are met on or ahead of time and within scope in a cost effective manner.
• Ensure company objectives are met through the selection, development, motivation and management of lab staff.
• Develop and implement strategic business initiatives with the objective of consistently producing accurate test results, maintaining clients and increasing business.
• Interact with clients/projects requiring multiple resources and effectively facilitate inter-company and interdepartmental initiatives and interactions to best meet the needs of the client/project.
• Participate in project quotes with attention to profitability and client satisfaction.
• Proactively participate in trade and professional associations to promote the company with the goal of increasing sales.
• Responsible for overall laboratory operations with attention to consistent implementation of policies, procedures and business practices.
• Ensure the attainment of company objectives through the selection, development, motivation and evaluation of lab staff.
• Directly manage the therapeutics laboratory relating to hiring, termination, and performance management issues.
• Ensure standard work processes are managed to milestones and deadlines. This includes Safety and quality metrics for the department/Company.

REQUIREMENTS & QUALIFICATIONS

Qualifications include a master’s and/or bachelor’s degree in chemistry or a related discipline is required. Must have chemistry laboratory experience with a minimum of 5 years of related work experience combined with a master’s degree as described above; or a minimum of 10 years of related work experience combined with a bachelor’s degree as described above.

Knowledge of cGMPs and related compliance regulations and guidance’s required.

Experience overseeing scientists in a fast-paced environment, effectively managing multiple projects simultaneously.

5 years of protein drug development experiences in a pharmaceutical contract laboratory environment and 3 years’ experience managing laboratory personnel.

Must have experience with current industry best practices for large molecule testing in the pharmaceutical and medical device industries.

Must have experience with the various products and services the company offers including method development, method validation, stability studies, method transfer and verification, LIMS, ELN and Chromatography Data Systems (SEC, HPLC), electrophoresis (e.g., CE-SDS, icIEF), mass spectrometry, and immunoassays

MINIMUM SKILLS REQUIREMENT

• Demonstrated skills in chemistry laboratory techniques.
• Solid computer skills.
• Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
• Must be a team player with integrity and concern for the quality of company products, services and staff members.
• Ability to properly schedule the workload to meet the varying demands.
• Ability to develop appropriate strategies used in the laboratory to address market segments or business growth.
• Self-starting, motivated person who possesses strong interpersonal who is able to motivate, train and monitor the laboratory personnel by establishing and maintaining guidelines for standards of performance.
• Delegate responsibilities to managers and group leaders.
• Proven ability to be an effective hands-on leader.
• Objectively evaluate the performance of others.
• Must have excellent organizational, verbal communication and technical documentation skills.