Senior Director Manufacturing Jobs

Jasper is a biotechnology company focused on enabling cures by targeting mast cells and stem cells. Our mission is to make safer and potentially curative therapy possible for most patients in need. We are bringing together a team of biotech veterans, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision of developing new therapies for diseases of mast and stem cells, safer and more effective conditioning for monogenic diseases and new engineered therapies.

Position Summary:

The Senior Director, Manufacturing is responsible for building and leading Jasper’s Manufacturing Division. Provides strategic direction and oversight for the flow of company products through production within budgeted costs and investments. Develops policies and programs, drives production schedules, facility/equipment maintenance schedules, materials requirement coordination, manufacturing equipment engineering and production quality control. This role is responsible for managing other employees.

Essential Functions/Major Responsibilities:

· Member of Technical Operation leadership team that plays a vital role in building robust manufacturing and supply chain infrastructure, develops global contract manufacturing network strategy to ensure steady delivery of drug to supply patients in need.

· Manage critical aspects of the external Drug Substance and Drug Product manufacturing relationship including communicating objectives, co-leading the JSC, monitoring CDMO performance and resolving operational and technical issues

· Ensure the needs and goals of key internal functions: Quality, CMC Regulatory, Supply Chain, and QC are understood and addressed.

· Apply the CDMO manufacturing management phase process to ensure reliable planned quality supply of Biologics Drug Substance. Implement strategies and tactics for monitoring and improving the performance of the CDMO in the areas of quality, compliance, delivery and COGs reduction

· Apply appropriate risk management process, per company Risk Management process

· Timely inform management of any significant risks to commercial supply, major projects and improvement activities, and/or budgets relating to drug manufacturing

· Lead and coordinate cross-functional efforts to resolve significant manufacturing issues

· Co-organize and co-lead inter-company meetings, JPT meeting with the Biologic Drug Substance and Drug Product partners

· Ensure that drug manufacturing is executed in accordance with the Master Supply Agreement, cGMP requirements and regulatory commitments

· Lead MSAT initiatives at the CDMOs for implementation of process improvements, technology transfers and process scale-up into manufacturing

· Participate in preparation, review and approval of CMC sections of regulatory filings

· Lead a next generation process improvement project to expand briquilimab franchise by increasing quality and reducing COGs for DS and DP manufacturing.

· Oversees the manufacture of products, ensuring production, performance, and quality standards are consistently met.

· Assists SVP, Technical Operations with long-range operating goals, expansion efforts, budgeting and implementation of new and advanced technology.

· Builds and organizes departmental management structure and teams for optimal, efficient operations.

· Supervises facility and equipment leasing and purchasing, maintenance, and layout.

· Reviews production reports to ensure safety, quality, financial, and delivery goals and standards are met.

· Identifies and shares training opportunities for staff to build and improve skills.

· Delivers progress and production reports to executive team members as requested.

· Ensures a healthy and safe working environment, and compliance with federal and state regulations, through collaboration with environmental, health, and safety staff.

· Performs other duties as required.

· Jasper reserves the right to amend these Main Responsibilities and any other portion of this job description at any time.

Qualifications:

EDUCATION

· -Master’s degree in a related field is preferred; Bachelor’s degree required.

EXPERIENCE

· 12 years of relevant experience, to include 5 years of people management experience

Capabilities Expected for Hire or Promotion to this Level

• Successful leadership of teams to accomplish multiple major Manufacturing objectives, from establishment of a pilot plant through evolution to a manufacturing facility. Acknowledged broadly across and outside the company as a subject matter expert.
• An entrepreneurial spirit, comfort learning new skills, and the flexibility to work on new projects as they arise are also important attributes for individuals in this role.
• Ability to work well in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines, and accountability for actions are all important competencies for this role.

· Excellent verbal and written communication skills.

· Excellent organizational and managerial skills.

· Thorough understanding of the policies and practices used in manufacturing divisions of similar type companies.

· Ability to set long-term goals and communicate them to others.

· Ability to motivate and organize multiple efforts to accomplish goals.

Environmental, Mental and Physical Demands

Environmental, mental and physical working environment demands described here are representative of those that must be met by an employee to successfully perform the primary functions of this job.

The working environment for this job includes working in a manufacturing setting as well as an office environment and research lab. Occasionally, repetitive tasks, prolonged standing, and the use of personal protective equipment (PPE) for handling hazardous and biohazardous materials may be required. See additional requirements for laboratory and research related jobs listed below.

The physical demands when working in the office environment are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.

Specific mental demands for the position are shown above under “Main Responsibilities.” In addition, mental demands for this job include the ability to:

• Multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
• Understand, follow and remember verbal and written instructions.
• National and International travel, up to 20%
• Maintain regular attendance and be punctual.
• Interact appropriately with a variety of individuals including vendors, customers and clients.
• Work and sustain attention with distractions and/or interruptions.