Director, Manufacturing Fill/Finish

Summary:

Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission to develop, manufacture and supply products that help people live better, healthier lives.

Catalent, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The Director, Manufacturing Fill Finish is responsible for leading teams and overseeing the GMP functions in the Class 100 cleanroom and Fill Finishing areas. This will be done by using broad knowledge of theories to solve operational, as well as routine task in the production of bulk biologics while overseeing the vial filling, visual inspection, labelling, and packaging operations in a GMP commercial manufacturing facility. The Director, Manufacturing Fill/Finish will report to the Sr. Director, Operations and has direct supervisory responsibilities over the Fill/Finish Manager and Supervisors.

The Role:

• Responsible for managing multiple teams of leaders and associates across multiple campaigns and shifts.
• Oversight of GMP fill finish production functions in the Class 100 cleanroom and Fill Finishing areas.
• Overseeing the vial filling, visual inspection, labelling, and packaging operations of bulk biologics in a GMP commercial manufacturing facility. Works closely with the production staff to troubleshoot process and equipment problems while ensuring appropriate and proactive client and internal stakeholder communication.
• Ensure team compliance with batch records, SOPs and training materials.
• Leads by example, keeping in mind organizational values, policies and goals. Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding and OJT is a positive experience.
• Ensures the proper processes are in place for GMP and Safety training of staff, with a focus on cross-training and continuously improves production records.
• Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives.
• Effectively communicates results of departmental work through team discussions and documentation
• Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns.
• Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture and ensure on time deliveries.
• Ensure team compliance with batch records, SOPs and training materials
• Closely partner with QA peers for closure of documentation required for timely disposition of batches.

The Candidate:

• Bachelor’s in Engineering or Science discipline and 12+ years of GMP biologic manufacturing experience OR
• Master’s in Engineering in a Science discipline plus 10+ years of GMP biologic manufacturing experience. Some or all this experience should be in Fill Finish operations.
• Must have experience in a CDMO or CMO environment.
• Minimum of 6 years of progressive leadership experience required, including direct people leadership and performance management experience.
• Ability to multi-task and demonstrate diplomatic skills.
• Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization.
• Ability to effectively present information and respond to questions from peers, management, suppliers and customers.
• Strong organizational skills.
• Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access).
• Ability to work effectively under pressure to meet deadlines.
• Subject matter expert on aseptic filling operations and labeling activities.

The anticipated salary range for this position in Maryland is $190,000 - $230,000 plus variable incentive compensation. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. 

Physical Demands: 

• Working with Comp