Head of Manufacturing, Science, and Technology

Andelyn Biosciences operations team is seeking a motivated individual to join our growing team as a Head of Manufacturing, Science and Technology. As a member of the Operations team you will be responsible for leading and building the a highly technical organization responsible for process development, laboratory methods development and development of product formulation.

This role will be responsible to build these functions out in accordance with regulatory guidelines. This role will assure all components meet the expectations, standards, and objectives of the company. Provide technical leadership, thought leadership and project management through the creation of the processes and continual improvement and management of processes.

Principal Duties and Responsibilities

Supports CGMP manufacturing Operations and Quality Control
Directs and assures successful scale-up and transfer of client-specific AAV gene therapy drug substance and drug product manufacturing processes from Development to CGMP
Identify, develop, and implement process improvements and technologies to provide differentiated offerings and maintain a competitive advantage to deliver cost-effective gene therapy products on time
Serve as an internal and client facing subject matter expert (SME)
Grow and lead the core MS&T groups including plasmid and vector development, upstream and downstream process development, analytical assays development, and formulation development
Oversee and assure the on time transfer of gene therapy products clients into GMP manufacturing
Interface between Development and CGMP Operations, and Quality Unit to streamline the transfer of cell culture processes, recovery, downstream purification, and fill/finish
Implement scalable process improvements to meet client demands to support clinical and commercial requirements
Identify new gene therapy technologies to maintain competitive edge. Provide clients with broad range of technical capabilities to meet client needs to fast track transition from Phase 1/2 to Phase 3 and commercial
Provide GMP operators with training on new processes
Provide guidance to technical staff on procedures and process for authoring transfer documents, detailed process descriptions and scale-up documents
Responsible for building service-oriented organization responsible for all individual areas requiring validation; including: Process, Equipment, Cleaning and Computer Systems
Oversees the site Master Validation Plan, using input from internal and external resources for continuous improvement. Creates, coordinates, and enforces Validation systems, policies, and procedures
Responsible for Periodic assessment and requalification program, Process, Equipment, Cleaning and CSV (Computer System Validation)
Manages validation department personnel; Hires, trains, coaches, and develops staff within the Validation team. Maintain adequate staffing levels for the department and workload. Monitors the performance of the validation department by tracking appropriate metrics and reporting the results to management
Responsible for the day-to-day activities conducted by the Validation Department. Establishes priorities to ensure that deadlines are met, and budgets are not exceeded
Liaise with outside vendors as a representative of validation and supervises the activities of external validation contractors
Oversees development and approval of Validation SOPs and validation-specific documents
Supports commissioning activities, projects, and validation functions by performing, preparing and reviewing/approving validation protocols and other documentation. Generates validation final reports as needed
Acts as Validation SME for manufacturing operations. Assess change controls with an accurate understanding of the bigger picture implications of changes
Communicates validation activities and schedules to other departments as required
Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner. Lead, oversee, and assure the on-time transfer of gene therapy products into GMP manufacturing
Interface between Development and CGMP Operations, and Quality Unit to streamline the transfer of cell culture processes, recovery, downstream purification, and fill/finish
Implement scalable process improvements to meet client demands to support clinical and commercial requirements
Identify new gene therapy technologies to maintain competitive edge
Provide clients with broad range of technical capabilities to meet client needs to fast track transition from Phase 1/2 to Phase 3 and commercial
Provide GMP operators with training on new processes
Provide guidance to technical staff on procedures and process for authoring transfer documents, detailed process descriptions and scale-up documents
Support investigations and investigation reports

Knowledge, Skills And Abilities Required

Bachelor’s Degree in technical area, advanced Degree preferred
At least 15+ years of relevant experience in validation in the biotech/pharmaceutical industry with 7+ years of direct employee management experience.
Working knowledge of validation and GxP requirements for commercial manufacturing.
10 years of experience in biopharmaceutical CGMP manufacturing operations including large scale cell culture, recovery, purification, formulation and fill/finish
Must be familiar with global regulations and requirements for advanced therapy medicinal products (ATMPs), US and EU requirements for developing robust Process Control Strategies
Working knowledge of requirements for sterile facilities.
Familiarity with multi-product manufacturing facility.
Ability to discuss validation policies and philosophies during audits/inspections by internal and external entities.
Ability to interpret cGMP requirements.
Ability to forecast and manage and prioritize multiple projects or assignments at one time.
Ability to follow assignments through to completion and meet deadlines.
Strong organizational skills.
Excellent verbal and written communication skills to all levels of the organization.
Strong experience working in cross-functional team.
Demonstrated desire to learn new technologies and ability to adapt to new operating models and changing business requirements effectively.
Must demonstrate a “can-do” attitude.

Minimum Physical Requirements

One needs to be able to lift 20-30 pounds occasionally (0-33% of the time).
May require ability to aseptically gown or wear other PPE on regular basis.
Must be able to stand for extended periods