Senior Manager/Associate Director, Manufacturing Sciences & Technology

Macrogenics Rockville , MD 20850

Posted 2 weeks ago

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 Senior Manager/Associate Director will lead and manage the Manufacturing Sciences and Technology (MSAT) group at MacroGenics. This group is responsible for providing technical support for internal and external manufacturing operations, including technology transfers and process and equipment validations. As a member of the site leadership team, the Senior Manager/Associate Director advises on manufacturing-related issues, initiatives and strategy for continuous improvement of site manufacturing performance and culture. This role will also represent the MSAT organization during customer/manufacturing network meetings, audits, and regulatory inspections. Responsibilities and Job Duties

  • Leads investigations of deviations and develops and implements corrective actions at cGMP manufacturing facilities to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.

  • Performs detailed data analyses and root cause analyses to identify solutions to complex problems and monitor and control process performance. Perform fit-to-plant projections and plan for new processes and implement processes in multiple manufacturing facilities.

  • Champions and implements change controls, leads selection of new equipment and materials, and manages their implementation at manufacturing facilities to improve existing and new processes.

  • Leads technology transfer activities to internal and external manufacturing sites and corporate partners and serves as technical expert in supporting manufacturing at CMOs. Engages with program managers to ensure projects are planned and executed appropriately in order to deliver to, and meet the needs of our customers and the business. Provides input to technical development early in the process to ensure facility/operational considerations are factored into process decisions.

  • Recruits, 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.

  • 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.

  • Identifies and communicates risks in area of responsibility and across the site. Creates strategies and plans to manage risk to operations.

  • Drives compliance with regulatory and quality requirements. Reviews and contribute to regulatory filings for products manufactured at CMOs as well as attends pertinent regulatory meetings as the functional owner. Champions and implements continuous improvement and operational excellence methods and tools to improve the overall efficiency of production operations. Delivers process control management and statistical controls throughout the manufacturing operations and work with appropriate continuous improvement tools such as OE and process controls integration, implement visual management/MDI, project management excellence, VSA & Kaizen's. Creates a positive environment for all functions to drive continuous improvement while they continue to deliver needed results/activities.

  • Leads continuous process monitoring and statistical modeling to manufacturing opportunities while building a continuous improvement culture & mentality within the organization. Actively engages in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites. Implements/supports business processes for continuous improvements.

  • Creates a high-performing team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.

Qualifications

Education

Bachelor's degree in a related area of study (STEM)

Experience

Senior Manager

  • At least 7 years of experience in process development, process scale up/manufacturing and process validation

  • Experience with commercial scale manufacturing support for mammalian cell culture, aseptic final product filling/kitting/labeling, liquid media manufacturing and/or analytical reagent manufacture, current Good Manufacturing Practices

  • A minimum of 3 years of direct people management experience including coaching, developing, and motivating the team to accomplish goals and objectives

  • Experience authoring and reviewing technical reports, standard operating procedures, on-the-job-trainings, and other controlled documents

  • Experience leading cross-functional teams, such as Quality, Process Science, Facilities and Engineering and Validation to implement processes and process improvements

  • Experience with participating in or leading culture/change

  • Experience with Deviation, CAPA, Change Control Systems

  • Experience in troubleshooting, investigations, root cause and performing risk analyses

Associate Director

  • At least 9 years of experience in process development, process scale up/manufacturing and process validation

  • Experience with commercial scale manufacturing support for mammalian cell culture, aseptic final product filling/kitting/labeling, liquid media manufacturing and/or analytical reagent manufacture, current Good Manufacturing Practices

  • A minimum of 4 years of direct people management experience including coaching, developing, and motivating the team to accomplish goals and objectives

  • Experience authoring and reviewing technical reports, standard operating procedures, on-the-job-trainings, and other controlled documents

  • Experience leading cross-functional teams, such as Quality, Process Science, Facilities and Engineering and Validation to implement processes and process improvements

  • Experience with participating in or leading culture/change

  • Experience with Deviation, CAPA, Change Control Systems

  • Experience in troubleshooting, investigations, root cause and performing risk analyses

Knowledge, Skills and Abilities

  • In depth knowledge of large scale biologic, pharmaceutical manufacturing, current Good Manufacturing Practices and US/EU regulations and intermediate knowledge of statistical data analysis. Knowledge should include a combination of cell biology, protein chemistry, and aseptic processing technologies and include small scale (laboratory) experience.

  • 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

  • Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding

  • Able to concisely communicate status, needs, forecasts, risks and timelines effectively to senior management

  • Displays a clear willingness to listen to others

  • Solid proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)

  • Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions

  • Ability to work independently and 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

  • Excellent Excel skills for analyzing and presenting data

Preferred Qualifications

  • Extensive training in multiple areas of Operational excellence, lean manufacturing, 6 Sigma, etc.

  • Ability to lead and document formal risk assessments

Supervisory Responsibilities
1 Science & Technology Associate

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.


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Senior Manager/Associate Director, Manufacturing Sciences & Technology

Macrogenics