Manufacturing Support Manager
The Manufacturing Support Manager is responsible for assisting in the planning, directing, and coordinating of the activities related to the cleaning and solution preparation processes while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics. The Manufacturing Support Manager will oversee the cGMP central services for aseptic conditons area compliance and soluton prepration manufacturing system.
- Oversee and provide leadership to the manufacturing support operations.
- Assist in organizing, managing and improving manufacturing support operations activities in support of the development of new products or processes and the manufacture of clinical and commercial products according to cGMPs in a timely manner.
- Ensuring the full compliance to OSHA and cGMP regulations of the manufacturing support operations at all times and working in concert with the Manufacturing Support Associate Director, Manufactuirng Director, QA, Engineering and Materials Management to ensure that the manufacturing support process is performing as required to meet client commitments.
- Working with the Manufacturing Support Associate 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 manufacturing support staff to ensure the timely delivery and right first time execution of manufacturing operations.
- Assist in maintaining the aseptic controls and formulation processes at the highest level of cGMP compliance per FDA and customer expectations.
- Help build, maintain and motivate the manufacturing support team in order to achieve productivity targets and output requirements to service clients with products on time.
- Assist the Manufacturing Support Associate Director and the Executive Leadership Team in establishing strategic directions for manufacturing support resources and activities, and setting objectives to maximize the value of the organization.
- Ensure continued operational efficiencies for manufacturing support are realized with reliable schedule adherence, lower conversion cost and increased productivity.
- Help establish priorities and assure adequate manufacturing support 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 Support Associate Director, Validation, Quality Assurance, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in manufacturing support operations.
- Monitor and report progress of the manufactuirng support processes to ensure FDBT meets the client and Company objectives.
- Participate in and represent manufacturing support operations in pre-approval inspections, FDA audits and client audits.
- Report manufacturing support and quality performance to the Manufacturing Support Associate Director 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 manufacturing support processes while adhering to corporate inventory objectives.
- Assist in developing manufacturing support plans and procedures for maintaining high standards of operations to ensure that products conform to established customer and company quality standards.
- Formulate and recommend manufacturing support 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 manufacturing support plan, consistent with established manufacturing, safety procedures and HR policies.
- Hire, train, develop and evaluate manufacturing support 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 Support Associate 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, motivate 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.
- Physical attendance is required.
- The following positions will directly report to the Manufacturing Support Manager: Central Services and/or Solution Preparation 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 6 years' experience in a managerial position.
- Associates or Technical 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 8 years' experience in a managerial position.
- High School/GED with a minimum of 12 years' relevant experience preferably in Biotechnology or Pharmaceutical Operations with at least 10 years' experience in a managerial position.
- GMP experience
- Experience in logistics/planning
- Experience in deviation management
- Lean Six Sigma – Black Belt
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.