Manages the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies. Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times.
Using a "hands-on" approach, ensures department goals and objectives are fulfilled effectively.
Prepares and reviews documentation, reports and standard operating procedures for drug product manufacturing as required.
Leads a team and participates actively in the manufacture of sterile drug products.
Provides guidance or trouble-shoots equipment as needed.
Ensures the effective use of materials, equipment and employees in producing quality products.
May formulate and recommend manufacturing policies, procedures and programs.
Selects, develops, evaluates and retains personnel to ensure the efficient operation of the group.
Actively manages the training program for the team and provides training as required.
Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times.
Works with Document specialists and QA to ensure timely completion of quality system documents such as deviations, change controls, CAPAs and quality investigations.
Ensures compliance with CDC regulations through inventory management, material traceability and training
Collaborate cross-functionally to manage process characterization and process validation studies in-house or through vendors
Write reports, summarize and present data succinctly
At least 5 years with a minimum of 3 years of management experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP standards, FDA and EU regulatory guidelines, SOPs and validation principles required.
Experience with Aseptic Fill/Finish of biologics.
Experience with Clinical and Commercial scale Fill/Finish activities.
Experience with toxin manufacturing preferred.
Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests.
Develop technical solutions to complex problems requiring use of ingenuity and creativity.
Experience leading a small team and providing guidance and mentorship.
Preferred Additional Skills (i.e., Computer):
Strong leadership, organizational planning and some project management skills.
Strong technical expertise.
Excellent communication skills.
Ability to work with a cross-functional team.
Ability to work effectively with other internal and external organizations.
Able to handle multiple projects at one time.