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Senior Scientist, Drug Product Process Development and Technology Transfer

Senior Scientist, Drug Product Process Development and Technology Transfer

ID 
2018-1120
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 Senior Scientist is a technical leadership role responsible for identifying and managing the implementation of suitable Drug Product manufacturing processes and related platforms for MacroGenics pipeline molecules. This position will be responsible for leading drug product projects and solving problems related to the development and optimization of drug product process unit operations.  Responsibilities include implementation of Drug Product process activities and developing the process control strategy working with contract Fill/Finish facilities necessary for clinical, commercial, and potentially Life Cycle Management (LCM) projects.               

 

Responsibilities and Job Duties

  • Leads process development, scale-up and technical transfer of Drug Product manufacturing processes, making detailed observations, analyzing data, interpreting results, maintaining documentation, and preparing precise technical reports, summaries and protocols.
  • Designs and optimizes various formulation and filling unit operations including freeze/thaw, mixing, sterile filtration, vial and syringe filling and lyophilization, and supports the execution of pilot to commercial scale fill/finish manufacturing process, ensuring scientific rigor in advancing project and technical platforms relating to drug product development within the group.
  • Ensures manufacturing processes are sufficiently robust for successful process performance qualification (PPQ) campaigns and that all process development and manufacturing activities are carried out in a manner consistent with regulatory requirements.
  • Leads preparation, authoring, and review of Drug Product manufacturing sections in regulatory documents and integration of Quality by Design and Process Validation principles into drug product development.
  • Presents findings at internal meetings and/or contributes to the preparation of manuscripts and patent applications.
  • Collaborates with key stakeholders within Development organization, and cross functional groups, to ensure efficient and productive cooperation with other groups and departments including: Supply Chain, Analytical Development, Manufacturing, Regulatory, Quality, Clinical Development, etc. Resolves complex problems within teams, departments, projects, programs and cross-functionally.
  • Perform all supervisory responsibilities for direct report(s) who support these activities. Provide coaching and mentoring to ensure staff development and feedback to maximize productivity and effectiveness.

Qualifications

Education & Experience

  • Bachelor’s in Chemical Engineering, Pharmaceutical sciences or life sciences and a minimum of 20 years of related experience

OR

  • Master’s in Chemical Engineering, Pharmaceutical sciences or life sciences and a minimum of 17 years of related experience

OR

  • PhD in Chemical Engineering, Pharmaceutical sciences or life sciences and 8 years of related experience
  • At least 5 years of supervisory experience

Knowledge, Skills and Abilities

  • Proven track record in applying fundamental scientific and engineering principles towards process development, process control, scale up and technology transfer
  • Familiarity with Quality by Design principles, Process Analytical Technologies (PAT), cGMP, as well as CMC requirements for regulatory filings globally especially in the USA and Europe
  • Ability to function independently to make critical project decisions based on lab investigations
  • Strong organizational skills allowing for oversight of CROs/CMOs
  • Knowledge of ICH guidelines and regulatory requirements
  • Experience drafting analytical sections for regulatory filings, such as INDs and BLAs
  • Ability to manage, train and mentor staff
  • Ability to lead cross-functional teams, be collaborative, and represent teams at a variety of forums
  • Experience in drug product characterization studies
  • Experience in overseeing PPQ campaigns
  • Experience in regulatory filings
  • Strong understanding of CMC functions
  • Strong communication, presentation, and writing skills

Preferred Qualifications

  • Experience with late stage development
  • Experience implementing process control strategy
  • Familiarity with use of statistical design software for process control and monitoring
  • Experience representing CMC teams in a matrix environment
  • Excellent understanding of cGMPs, with expertise in Drug Product regulatory and clinical requirements
  • A track record of promoting platform and technology reuse; establishing processes that create a constructive balance between customization and standardization
  • Understanding of the drivers for project success and previous experience making necessary investments in DP project management to improve pipeline productivity
  • Recognized technical expert in biologics Drug Product engineering and product innovation
  • Author of publications in biologics Drug Product development journals

Supervisory Responsibilities

Scientist II, Scientist I, Development Associate III

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.