Oversees and directs 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.
• Oversees the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies.
• Using a “hands-on” approach, ensures department goals and objectives are fulfilled effectively.
• Leads a team and participates actively in the manufacture of sterile drug products.
• Provides guidance or trouble-shoots equipment as needed.
• Prepares documentation, reports and standard operating procedures as required.
• Ensures the effective use of materials, equipment and employees in producing quality products.
• May monitor and control labor and capital expenditures.
• May assist in developing budgets.
• Formulates and recommends manufacturing policies, procedures and programs.
• Selects, develops and evaluates and retains personnel to ensure the efficient operation of the function.
• Ensure compliance with CDC regulations through inventory management and material traceability
• Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times.
• Collaborate cross-functionally to mage process characterization and process validation studies
• Write reports, summarize and present data succinctly
• 6-8 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 lead and support 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.
• Candidates must possess a BS in Mechanical Engineering, Chemical Engineering or related discipline.
Preferred Additional Skills (i.e., Computer):
• Strong leadership, organizational planning and 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.