Summary: The Downstream Manufacturing Manager – FBF 200 is responsible for assisting in the planning, directing, and coordinating of the activities related to the Downstream manufacturing processes for the start-up of the new Flexible BioManufacturing Facility – 200 (FBF – 200) while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manufacturing Manager, Downstream will oversee the cGMP production and Downstream manufacturing systems working directly with a range of purification technologies including continuous flow centrifugation, sucrose gradient separation, various filtration technologies (TFF & depth), chromatographic separations technologies (GE AKTA systems), and viral inactivation following aseptic techniques in a cGMP environment.
- Oversee and provide leadership to the downstream manufacturing operations.
- Assist in organizing, managing and improving downstream 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.
- Ensuring the full compliance to OSHA and cGMP regulations of the downstream manufacturing operations at all times and working in concert with the Manufacturing Director, QA, Engineering and Materials Management to ensure that the downstream manufacturing process is performing as required to meet client commitments.
- Working with the Manufacturing Director, 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 Downstream manufacturing staff to ensure the timely delivery and right first time execution of manufacturing operations for single use large-scale filtration and centrifugation systems including Tangential Flow Filtration (TFF) and depth filtration, Sucrose Density Centrifugation, Continuous Flow Centrifugation and Clarification and large-scale Chromatographic systems (AKTA).
- Assist in maintaining the Downstream processes at the highest level of cGMP compliance per FDA and customer expectations.
- Help build, maintain and motivate the downstream team in order to achieve productivity targets and output requirements to service clients with products on time.
- Assist the Manufacturing Director – FBF 200 and the Executive Leadership Team in establishing strategic directions for downstream manufacturing resources and activities, and setting objectives to maximize the value of the organization.
- Ensure continued operational efficiencies for downstream manufacturing are realized with reliable schedule adherence, lower conversion cost and increased productivity.
- Help establish priorities and assure adequate downstream 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 Director, Validation, Quality Assurance, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in downstream manufacturing operations.
- Monitor and report progress of the downstream processes to ensure FDBT meets the client and Company objectives.
- Participate in and represent downstream manufacturing operations in pre-approval inspections, FDA audits and client audits.
- Report Downstream manufacturing and quality performance to the Manufacturing Director FBF 200 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 downstream manufacturing processes while adhering to corporate inventory objectives.
- Assist in developing downstream manufacturing plans and procedures for maintaining high standards of downstream manufacturing operations to ensure that products conform to established customer and company quality standards.
- Formulate and recommend downstream 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 downstream manufacturing plan, consistent with established manufacturing and safety procedures.
- Hire, train, develop and evaluate downstream 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 Director and Human Resources as appropriate.
- 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 Production Manager, Downstream – FBF 200: supporting technical 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 in logistics/planning
- Lean Six Sigma – Black Belt