Manufacturing Manager, Upstream
The Manufacturing Manager, Upstream – NCTM is responsible for assisting in the planning, directing, and coordinating of the activities related to the Upstream manufacturing processes for the National Center for Therapeutics Manufacturing (NCTM) while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manufacturing Manager, Upstream will oversee the cGMP production and Upstream manufacturing systems working directly with cell culture and viral propagation techniques, cell culture and bioreactor operations, bacterial and fermentation operations, pDNA, protein, and yeast related operations, and aseptic techniques while following cGMP procedures.
- Oversee and provide leadership to the Upstream manufacturing operations.
- Assist in organizing, managing and improving Upstream manufacturing operations activities in support of the development of new products or processes and the manufacture of clinical products according to cGMPs in a timely manner.
- Ensure full compliance to OSHA and cGMP regulations of the Upstream manufacturing operations at all times and working in concert with the Manufacturing Associate Director NCTM, QA, Engineering and Materials Management to ensure that the Upstream manufacturing process is performing as required to meet client commitments.
- Working with the Manufacturing Associate Director NCTM, Metrology, Engineering and Facilities groups on site ensuring compliance and effectiveness through maintaining appropriate Engineering standards, maintenance and calibration of equipment according to all required standards.
- Assist in directing the Upstream manufacturing staff to ensure the timely delivery and right first time execution of manufacturing operations for multiple products using single use cell culture vessels/bioreactors.
- Assist in maintaining the Upstream processes at the highest level of cGMP compliance per FDA and customer expectations.
- Help build, maintain and motivate the Upstream team in order to achieve productivity targets and output requirements to service clients with products on time.
- Assist the Manufacturing Associate Director NCTM and the Executive Leadership Team in establishing strategic directions for Upstream manufacturing resources and activities, and setting objectives to maximize the value of the organization.
- Ensure continued operational efficiencies for Upstream manufacturing are realized with reliable schedule adherence, lower conversion cost and increased productivity.
- Help establish priorities and assure adequate Upstream resources to complete projects in a timely manner.
- Assist in completing investigations in a timely manner and ensuring root causes are correctly identified.
- Work directly with Manufacturing Associate Director, Validation, Quality Assurance, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in Upstream manufacturing operations.
- Monitor and report progress of the Upstream processes to ensure FDBT meets the client and Company objectives.
- Participate in and represent Upstream manufacturing operations in pre-approval inspections, FDA audits and client audits.
- Report Upstream manufacturing and quality performance to the Manufacturing Associate Director NCTM on a regular (i.e., monthly) basis through the use of various site metrics.
- Ensure adequate levels of materials are maintained in support of the Upstream manufacturing processes while adhering to corporate inventory objectives.
- Assist in developing Upstream manufacturing plans and procedures for maintaining high standards of Upstream manufacturing operations to ensure that products conform to established customer and company quality standards.
- Formulate and recommend Upstream manufacturing policies and programs that guide the organization in maintaining and improving its competitive positions and the profitability of the operations.
- Direct and monitor team members to accomplish goals of the Upstream manufacturing plan, consistent with established manufacturing and safety procedures.
- Hire, train, develop and evaluate Upstream manufacturing 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 the Manufacturing Associate Director and Human Resources as appropriate.
- Support of other manufacturing areas within the Gene Therapy and Vaccines business at FDBT
- Perform other duties and projects as assigned and required.
Required Skills & Abilities:
- Strong leadership qualities and demonstrated success in management of change.
- Ability to coordinate, facilitate and organize resources.
- Ability to develop strategic relationships; strong verbal and written communication skills; good presentation skills.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to work effectively under extreme pressure to meet deadlines.
- Well organized with ability to handle multiple activities simultaneously.
- Detail oriented and accurate.
- Excellent computer skills and proficient in MS Office (Word, Excel, Outlook, PowerPoint).
- Good 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 hire, train, and develop employees to grow within the organization.
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:
- Experience prolonged sitting, some bending, stooping and stretching.
- 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.
- The following positions will directly report to the Manufacturing Manager Upstream NCTM: supporting technical and supervision staff.
- Master's degree preferably in business, engineering, science, or a related field with a minimum of 6 years experience preferably in Biotechnology or Pharmaceutical Operations with at least 4 years experience in a managerial position; OR
Bachelor'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 4 years experience in a managerial position.
- cGMP experience
- Experience with cultivation at a minimum of pilot scale cell culture vessels
- Experience with Mammalian Cell, Insect Cell, Yeast or Bacterial Cell Lines preffered
- Experienced with pDNA, and Viral Propagation technologies prefferred
- Experience in Logistics and planning
- Experience in Project Management
- Lean Six Sigma – Green Belt or higher
- Downstream and Buffer/Media Preparation
- Large scale commervial manufacturing experience
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 FDBTHR@fujifilm.com or call 979-431-3500.