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Director/Senior Director, Cell Culture Sciences

Director/Senior Director, Cell Culture Sciences

ID 
2018-1138
Category 
Development
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 Director/Senior Director, Cell Culture Sciences is a strategic and technical manager responsible for early and late stage process development and optimization, as well as late stage process characterization and validation of cell culture unit operations. In addition, this role oversees cell line development for our molecules.  This individual is responsible for designing and executing studies to develop process control strategies for the pipeline molecules to support initial manufacturing and IND submissions. He/she will work closely with other development functions, including purification, analytical, and formulation, and collaborate with manufacturing, validation, quality and regulatory functions to support development of molecules leading to commercialization. This Director/Senior Director will drive talent management processes focused on the selection and development of employees who to support these activities. 

 

Responsibilities and Job Duties

  • Lead early stage pipeline programs, including process development, scale-up, toxicology material production, technology transfer, clinical material manufacturing support, and IND submissions, to support development of molecules leading to commercialization.
  • Define strategic goals and lead the efforts for late stage program strategies toward commercialization, including the design, coordination, and execution of process characterization and small and large scale validation studies.
  • Manage the screening, optimization, selection and creation of clonal cell banks.
  • Oversee the technology transfer of developed cell culture processes to internal and external GMP manufacturing sites.
  • Establish and qualify scale-down bioreactor models to support characterization studies and cGMP manufacturing.
  • Author upstream process development and cell line development sections of IND, BLA, and other regulatory documents such as protocols and technical reports in collaboration with the development, quality, and regulatory groups to support regulatory filings.
  • Recruit, motivate, retain and develop key employees. Build and sustain employee engagement by creating an environment where individuals and teams can excel. Establish departmental and individual goals and objectives in alignment with corporate goals and priorities. Identify performance improvement targets and metrics.
  • Responsible for the department’s annual budget and quarterly forecasting processes. Manage head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives.
  • Create a high-performing team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.
  • Present scientific findings at internal and external meetings and champion scientific journal publications. Represent MacroGenics at meetings with collaborators
  • Serve as subject matter expert related to upstream process and cell line development, including all process and manufacturing related activities, risk assessments, characterization, investigations, regulatory interactions, and project team requirements.
  • Champion and implement business processes for continuous improvements and support continuous improvement culture & mentality within the organization. Actively engage in the identification, sharing and adaptation of best practices cross-functionally

Qualifications

Education & Experience

Director

 

  • Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 20 years of biotech industrial experience working with cell culture and/or cell line development

Or

  • Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 15 years of biotech industrial experience working with cell culture and/or cell line development

Or

  • PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 10 years of biotech industrial experience working with cell culture and/or cell line development

 

 

Senior Director

 

  • Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 22 years of biotech industrial experience working with cell culture and/or cell line development

Or

  • Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 17 years of biotech industrial experience working with cell culture and/or cell line development

Or

  • PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 12 years of biotech industrial experience working with cell culture and/or cell line development

 

 

 

  • At least 5 years of direct people management experience including coaching and developing a team and providing motivation to accomplish goals and objectives
  • Significant hands on experience with bench to intermediate scale single use bioreactors, developing high titer cell culture processes; media development and process scale-up experience
  • Experience in managing budgets, project timelines, and resources to accomplish objectives

 

Knowledge, Skills and Abilities

 

  • Specific knowledge and in-depth understanding of cell culture and scale up processes
  • Solid understanding of current FDA and ICH guidelines regarding cell culture/drug substance processes to meet regulatory expectations
  • Ability to critically analyze data using statistical tools for process performance to compile technical reports and other documentation
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with internal and external stakeholders
  • Strong understanding of statistical tools and knowledge of DOE and QbD principles
  • Proven track record of authoring, executing and reviewing both small and large scale validation protocols
  • Strong understanding of CMC functions
  • Ability to collaborate with and influence other functional areas such as Validation and Regulatory Affairs
  • Ability to support and effectively multi-task different and complex assignments and responsibilities
  • Ability to manage, train and mentor staff
  • Strong presentation and writing skills to communicate effectively internally and externally
  • Ability to lead cross-functional teams, be collaborative, and represent teams at a variety of forums
  • Ability to set-up, maintain, and troubleshoot equipment

Preferred Qualifications

Late stage experience, including cell line development, process development, process characterization, validation and commercialization strongly preferred

 

Supervisory Responsibilities

BioProcess Associate(s) and/or Scientist(s)

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.