MEDVACON Life Sciences is a pharma/bio-pharma & medical device consulting and talent placement firm specializing in cGMP Quality, Compliance, Regulatory & Validation Services, Talent Acquisition, temp-hire & permanent, full-time directly with our clients.

We're assisting our client with hiring a full-time/perm Director of  Aseptic Bulk-fill Mnfg

Did you know?? The position is located in a suburb of Indianapolis and recently named the #1 place to live in the US by Money Magazine for its livability, safety and entrepreneurship. One of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. 

The company has much to offer and will assist with relocation expenses.

[ The company is also hiring for Associate Dir, downstream process,  Vice President, Supply Chain Manager and QC Manager]  Please feel welcome to share with your network.

Manage the viral manufacturing processes including responsibility for the planning, on-time execution, and delivery of quality product. Also responsible for the training and development of the Manufacturing team and continuous improvement of the Manufacturing processes.  As part of routine operations, you'll work with the cross-functional teams, including Engineering, Facilities, EHS, Quality Assurance, IT, HR, Process Development, and Quality Control to support site operations.  

• Hire, lead, and develop the Manufacturing team to meet group objectives successfully
• Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts
• Plan and execute manufacturing activities on time
• Deliver product on time to clients, including review of Manufacturing records and investigations
• Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements
• Implement highest standards of compliance with quality systems into the day-to-day activities and maintain compliance with all applicable guidelines and regulations
• Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety
• Partner with business development for evaluation of potential business opportunities, assessing project plans and their feasibility
• Manage process tech transfer activities from Process Development into Manufacturing
• Work with Quality Assurance to establish the Manufacturing System (as defined in FDA 6 systems) for viral vector Manufacturing
• Participate in client management and report Manufacturing status and progress directly to clients
• Act as the Manufacturing system subject matter expert for client and regulatory audits

• Degree in Biology, Chemistry, or Engineering
• 10+ years of experience in biopharmaceutical Manufacturing and aseptic processing
• Expertise in protein or gene therapy vector purification and Manufacturing helpful
• 5+ years of related experience in a GMP setting
• 5+ years of leadership experience
• Experience using single use systems is preferred
• Expertise in aseptic processing and bulk-fill is required
• Knowledge of Viral Vector is a ++
• Experience with optimizing, scaling, and tech transferring Manufacturing processes

• Paid vacation days, amount based on tenure, and paid sick time
• 8 observed holidays + 1 floating holiday
• 401(k) plan with company match up to 6% of salary, vested immediately
• Choice of five healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance

NO! Agencies or 3rd party agencies.  We do not work through other employers

US work eligibility

Please attach a WORD resume to your submission

All of your information will be kept confidential according to EEO guidelines.

EOE/Veteran/Disabled