Site Head, Manufacturing - GMP Biologics

Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

The Site Head, Manufacturing will be responsible for the operational and compliance performance necessary to drive growth and customer excellence. Working cross-functionally with Quality, Engineering, Supply Chain, HR, Project Management and Finance, the Site Head will be responsible for organizing, managing and improving Operations activities in support of the development of new products or processes and the manufacture of clinical and products according to cGMPs. The successful individual is responsible for building strong working relationships across the site and driving employee and customer engagement to next level and ultimately delivering safe and effective products to patients. The role is also responsible for building both a high performing team and high performing systems in order to drive and sustain business growth and to meet the demands of a complex customer base.

Key Responsibilities:

• Enable manufacturing staff to ensure the timely delivery and execution of manufacturing operations for development projects and manufacturing batches.
• Collaborate with Executive Leaders in establishing strategic direction for manufacturing resources and activities, and setting objectives to maximize the value of the organization's contributions by adapting new technologies, capabilities and providing educational opportunities for team members.
• Maintain the operational facility in the highest level of cGMP compliance per FDA and customer expectations.
• Ensure that all operations are compliant with Paragon Bioservices EHS and Security Standards and OSHA and EPA requirements at all times. Ensure all company and site policies are adhered to and ensuring appropriate company disciplinary policies are followed consistently.
• Build, maintain and motivate a manufacturing team capable of achieving all productivity targets and output requirements to service customers with product on time
• Partner with Facilities & Engineering groups to ensure effective standards are maintained for the maintenance and calibration of equipment/facilities to support manufacturing.
• Cross functional collaboration with Validation, Quality Assurance, QC & MS&T functional areas to plan and implement the execution of cGMP activities in manufacturing operations for both development processes and commercial operations.
• Ensure continued operational efficiencies are realized with reliable schedule adherence, and on time delivery of product, while maintaining the ability to react to changing customer requirements.
• Share responsibility for short and long term resources and facility planning, and perform managerial duties as required, e.g. budgets, personnel performance appraisals, training, etc.
• Monitor and report progress of projects within agreed upon time lines, ensuring customer and Company objectives are met.
• Responsible for participating and representing all manufacturing operations in client audits as appropriate.
• Develop quality and business metrics for assessing productivity/profitability of manufacturing.
• Develop and manage the budget requirements for each fiscal year. In agreement with GM, organize the purchase of appropriate capital items as required for projects.
• Liaise with vendors and suppliers as a technical representative.
• Other responsibilities as assigned.

Education & Experience:

• Bachelor's degree in an Engineering or Scientific discipline with 20+ years' in an operations, Process Development or MS&T function (or combination) in the Pharmaceutical/Biotech industry with 10 years of this being in a managerial position.
• Significant experience with biologics (microbial, cell culture) manufacturing and production process and equipment.
• Experience in a CMO or CDMO environment required
• Experience in deviation and technical investigations and managing teams of >20 is necessary.
• Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor.
• Outstanding interpersonal skills; ability to build strong relationships with cross-functional team members and lead through influence
• Strong business orientation and financial skills.
• Excellent negotiation and contracting skills.
• Ability to "get the job done" and take responsibility for results without direct authority.
• Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.
• Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.
• Skilled in Lean Six Sigma.

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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