Summary: This position is responsible for establishing a production and supporting cross-functional activities plan to enable to delivery of products from FDBT’s three manufacturing facilities per the site Sales & Operations Plan. This position is responsible for scheduling product change over, room release, equipment movement, equipment calibration/qualification activities, GMP document issuance, materials staging, buffer preparation, unit operations schedule, and batch record review schedule.
- Develops the macro and micro schedules to support Buffer Prep, Central Services, Upstream, and Downstream Manufacturing for each product.
- Act as a primary contact with Manufacturing to maximize resource utilization and cross-departmental collaboration.
- Works with Supply Chain to understand any material concerns or shortages and communicates schedule changes to Supply Chain for material assessments.
- Works with readiness coordinators and production managers within Manufacturing to ensure materials and records are available to meet production schedules.
- Identify and communicate resource (people, equipment, facilities) gaps for the new business pipeline to site leadership and program managers.
- Collaborate with manufacturing and program management to ensure buy-in for execution of the manufacturing plan.
- Maintain manufacturing metrics for on time supply and success for weekly and monthly reports.
Required Skills & Abilities:
- Ability to coordinate, facilitate and organize resources.
- Ability to develop strategic relationships; strong verbal and written communication skills.
- Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project, and Schedule Pro.
- Mathematical and reasoning ability.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Strong organizational skills.
- Detail oriented and accurate.
- Proven success in leading complex projects and bringing them to conclusion.
- Ability to persuasively champion strategic ideas, as supported by sound rationale and analysis, and drive change within the organization.
- Strong knowledge of concepts, practices, and procedures related to the biotechnology industry.
- Strong analytical, interpersonal, presentation and problem solving skills.
- Ability to analyze, break-down, and interpret a wide variety of information and form a strategic opinion while addressing the operational implications.
- Self-discipline and good attention to detail.
- Excellent computer skills.
- Must have planning skills and be willing to interface with colleagues in many different roles and functions throughout the manufacturing facilities and to lead projects.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
- Attendance is mandatory.
- Bachelor’s degree in Science, Engineering or other related field and 3 years of relevant experience; OR
- Associate’s degree in Science, Engineering or other related field and 5 years of relevant experience; OR
- High School diploma/GED with 7 years of Biopharmaceutical experience and or Planning experience.
- Experience in biotechnology or pharmaceutical industry.
- GMP experience.