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Associate Director, Manufacturing

Associate Director, Manufacturing

ID 
2017-1096
Category 
Manufacturing
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Associate Director leads and manages upstream and downstream manufacturing operations for one of MacroGenics’ cGMP manufacturing sites in a multi-product facility for clinical and commercial supply. This individual will create a high performing work environment to ensure the overall production schedule and lot release schedule are met while maintaining a high level of quality and compliance. This role is responsible for meeting financial and quality performance goals and for supporting regulatory inspections and audits as necessary.

              

Responsibilities and Job Duties

  • Serves as the senior leader for the manufacturing operations at a site focused on the manufacturing of clinical drug supply.  Effectively plans, leads, and manages the team to meet quality and productivity goals and objectives that comply with all safety and GMP regulations.  
  • Identifies the required resources and expertise, implementing the appropriate team/departmental structures and establishing the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
  • Responsible for contributing to the department’s annual budget and quarterly forecasting processes.  Manages head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives.
  • Ensures that all staff are trained properly in all GMP operations and documentation. Motivates, retains and develops key employees. Builds and sustains employee engagement by creating an environment where individuals and teams can excel. Establishes departmental and individual goals and objectives in alignment with site goals and priorities. Identifies performance improvement targets and metrics. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets.
  • Identifies and communicates risks in area of responsibility and across the site. Creates strategies and plans to manage risk to the operations.
  • Manages and supports projects that require cross functional interaction and ensures alignment between all manufacturing staff and supporting groups (e.g. Quality Assurance, Quality Control, Validation, Facilities, Materials Management).
  • Ensures manufacturing sections of regulatory filings are completed accurately and on schedule.
  • Supports successful implementation of new products and processes into the facility, including overseeing batch record creation, SOP creation, change control implementation, new equipment procurement, and area changeover activities.
  • Champions and implements continuous improvement and operational excellence methods and tools to improve the overall efficiency of production operations.       
  • Actively engages in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites. Implements/supports business process for continuous improvements.

Qualifications

Education

Bachelor’s degree in a related area of study

 

Experience

  • At least 9 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industries
  • A minimum of 4 years of direct people management experience including coaching and developing the team and providing motivation to accomplish goals and objectives
  • Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
  • Experience leading manufacturing teams to maintain adherence to a demanding production schedule, working with cross-functional teams, such as Quality, Process Science, Facilities and Engineering and Validation
  • Experience with Deviation, CAPA, Change Control Systems (i.e. Master Control)
  • Experience in troubleshooting, investigation, root cause and risk analysis in a cGMP environment
  • Experience writing regulatory documents (INDs)

 

Knowledge, Skills and Abilities

  • Demonstrated ability to set vision and direction for a team including setting expectations and accountability
  • Demonstrated ability to collaborate with cross functional teams resulting in creative and positive outcomes
  • Excellent motivation and coaching skills and ability to communicate to the team how their roles fit into the overall drug development process and the impact their performance has on the company and patients
  • Excellent organizational skills and attention to detail required
  • Results driven with demonstrated successful outcomes
  • Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
  • Strong written and verbal communications skills
  • Solid proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)
  • Good knowledge of supply chain theory and practice
  • Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions
  • Ability to work independently lead a cross-functional team to support corporate goals
  • Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment

 

Supervisory Responsibilities

Two Manufacturing Managers

 

Preferred Qualifications

  • Six Sigma training
  • Ability to lead and document formal risk assessments

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service. 

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.