Validation & Equipment Program Manager Merrimack Pharmaceuticals
THIS JOB HAS EXPIRED Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.
This is an exciting opportunity to start the development of two critical operation teams at a cutting-edge biotechnology company. This position will be responsible for establishing a validation and equipment program management function at Merrimack Pharmaceuticals, which could eventually lead to the creation of two distinctive operation teams. The individual will be responsible for the creation, implementation, and management of validation at Merrimack Pharmaceuticals, as well as streamlining and management of a GMP equipment program.
Develop validation master plans and policies and ensure proper execution.
Oversee and review validation procedures, make recommendations for changes and/or improvements.
Coordinate preventive maintenance and calibration of equipment.
Manage third parties performing equipment maintenance and calibration services.
Coordinate with manufacturing operations for timely maintenance of equipment while minimizing impact to manufacturing schedules.
Based on significant technical expertise, reviews and approves complex design concepts and provides general direction to technical staff.
Schedule, plan and manage validation projects including: new facility planning and construction, equipment qualification and validation and providing input on computer-based systems and software.
Oversight of the development and completion of documentation on protocols, Validation Master Plans, and Validation Summary Reports.
Create equipment specification documents.
Perform technical failure analysis of processes/product not meeting specifications, develop statistical process control programs to monitor processes and report on trends to reduce product/process variability.
Approve protocols and support documentation (assess impact of change control requests on validated state of equipment, process, and facility).
A minimum of a BA or BS, preferably in Life Sciences, Engineering, Math or Chemistry or other job-related discipline.
A minimum of 10 years of related experience in validation, including equipment, within a pharmaceutical, biotech, devices, or related industry and 3 years of project management experience required.
Excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel. Also must be able to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk
Proficient in Microsoft Word and Excel, and other relevant computer software.
Knowledge of GMPs, FDA guidelines, and process validation.
Experience and knowledge of metrology programs and creation of equipment specifications.
Diverse experience including clean utilities, facility systems, process support systems, bioprocess manufacturing, packaging equipment and cleaning processes is desirable.
Experience with good documentation processes, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
Strong verbal communication and technical writing skills.
||One Kendall Square |
Building 700, Second Floor
Cambridge, MA 02139
THIS JOB HAS EXPIRED