Director Of Manufacturing (Gmp)

Summary:

The Manufacturing Director is responsible for the planning, directing, and coordinating activities related to the manufacturing processes for the Watertown facility while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manufacturing Director will be responsible for the cGMP production, manufacturing and systems that support the manufacture of virus-related vaccines and biotherapeutic products in a BSL 2 state-of-art facility.

The Manufacturing Director will be the first manufacturing FTE at the Watertown facility and will be responsible for designing and building a lean manufacturing organization that is suitable for first in human gene therapy products whilst following FDB principals of operation. Manufacturing at this location will come online within 12-18 months of job placement and initial responsibilities will be focused on facility startup activites, leveraging existing operating philosophies, procedures and systems from FDB, Texas.

Essential Functions:

• Work directly with Validation, Quality Assurance, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in manufacturing operations for development processes.
• Responsible for participating and representing all manufacturing operations in pre-approval inspections, FDA audits and client audits.
• Formulate and recommend manufacturing policies and programs that guide the organization in maintaining and improving its competitive positions and the profitability of the operations.
• Direct and monitor department managers to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures. Act as a liaison between department management/subordinate levels, as well as executive leadership/department manager levels to inform personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results.
• Direct manufacturing staff to ensure the timely delivery and right first time execution of manufacturing operations for multiple viral products in single rooms.
• Working with the Metrology, Engineering and Facilities groups either within or external to the organization, ensuring compliance and effectiveness through maintaining appropriate Engineering standards, maintenance and calibration of equipment according to all required standards.
• Hire, train, develop and evaluate staff. Take corrective action as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal, state, and local regulations in consultation with Human Resources as appropriate.
• Organizing, managing and improving manufacturing operations activities in support of the development of new products or processes and the manufacture of viral products according to cGMPs in a timely manner.
• Perform other duties and projects as assigned and required.
• Represent the organizational unit as the prime internal and external contact for Watertown manufacturing operations.
• Complete investigations in a timely manner and ensure root causes are correctly identified.
• Maintain the operational facility in the highest level of cGMP compliance per FDA and customer expectations.
• Develop and manage the budget requirements for each fiscal year and organize the purchase of appropriate capital items as required for projects.
• Ensuring the full compliance to OSHA and cGMP regulations of the manufacturing operations at all times and working in concert with QA, Engineering and Materials Management to ensure that the manufacturing operations area is performing as required to meet client commitments.
• Provide technical support to the Commercial Development group through participation at customer meetings relating to all technologies.
• Assist the Executive Leadership Team in establishing strategic direction for manufacturing resources and activities for Watertown, and setting objectives to maximize the value of the organization.
• Establish priorities and assure adequate resources to complete projects in a timely manner.
• Use Lean Six Sigma tools in day-to-day operations and to improve the operation.
• Build, maintain and motivate a multi technology operations team capable of achieving all productivity targets and output requirements to service clients with products on time.
• Directing and providing technical leadership for the overall manufacturing operations for the viral vector products and specialty drugs.
• Ensure continued operational efficiencies are realized with reliable schedule adherence, lower conversion cost and increased productivity.
• Monitor and report progress of projects within agreed upon time lines, ensuring client and Company objectives are met.
• Develop manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.
• Share responsibility for short and long term resources and facility planning, and perform managerial duties as required, e.g. budgets, personnel performance appraisals, etc.
• Report manufacturing and quality performance on a regular (i.e., monthly) basis through the use of various site metrics.

Required Skills & Abilities:

• Detail oriented and accurate.
• Ability to develop strategic relationships; strong verbal and written communication skills; excellent presentation skills.
• Ability to work effectively under pressure to meet deadlines.
• Clear leadership qualities and demonstrated success in management of change.
• Ability to hire, train, and develop employees to grow within the organization.
• Strong interpersonal skills with an understanding of diverse backgrounds and an emphasis on communication: training, team building, negotiation skills, interdepartmental interactions, leadership and supervision (motivation, directing) and management (planning, budgeting, etc.)
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Well organized with ability to handle multiple activities simultaneously.
• Excellent computer skills and proficient in MS Office (Word, Excel, Outlook, PowerPoint).
• Ability to coordinate, facilitate and organize resources.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• May be required to lift up to 40 pounds on occasion.
• Attendance is required.
• Experience prolonged sitting, some bending, stooping and stretching.

Supervisory Responsibilities:

• Upon build-out of the organization the following Manager/supervisor level roles will directly report to the Manufacturing Director: Technical Operations, Manufacturing Support, logistics and compliance, upstream and downstream.

Minimum Qualifications:

• Experience in GMP environment.
• High School diploma or equivalent with a minimum of 14 years’ experience preferably in Biotechnology or Pharmaceutical Operations with at least 6 years’ experience in a managerial position.
• Bachelor’s degree preferably in business, engineering, science or a related field with a minimum of 10 years’ experience preferably in Biotechnology or Pharmaceutical Operations with at least 6 years’ experience in a managerial position; OR
• Associates degree minimum of 12 years’ experience preferably in Biotechnology or Pharmaceutical Operations with at least 6 years’ experience in a managerial position; OR
• Master’s degree preferably in business, engineering, science, or a related field with a minimum of 8 years’ experience preferably in Biotechnology or Pharmaceutical Operations with at least 6 years’ experience in a managerial position; OR

Preferred Qualifications:

• Experience in logistics/planning
• Lean Six Sigma – Black Belt Certification
• Manufacturing in BSL 2 environment

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail [email protected] or call 979-431-3500.