Scientist II - Purification Sciences
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 Scientist II - Purification Sciences is responsible for the development, characterization and validation of purification processes for late-stage pipeline products. The individual will help establish late stage characterization and validation strategies while also participating in process development activities. The position necessitates a collaborative approach with other Development functional groups, Manufacturing, Validation and Regulatory Affairs towards the goal of transitioning products from development to commercialization.
Responsibilities and Job Duties
- Establish process characterization and validation strategy
- Design, coordinate and execute process characterization studies
- Design and execute small scale and large scale validation studies
- Presentation of validation and characterization study results to internal teams
- Draft protocols and reports in support of regulatory filings
- Write the relevant sections for regulatory submission
Education & Credentials
BS, MS, or PhD in the biological sciences or related field
- BS with a minimum of 14 years of experience, MS with a minimum of 11 years of experience or PhD with a minimum of 2 years of experience
- Minimum of 5 years of biotech industry experience
- Demonstrated ability to perform small-scale model studies using Design of Experiments (DOE) approach
- Experience operating purification equipment such as AKTA or equivalent
Knowledge, Skills and Abilities
- Possess in-depth understanding of downstream unit operations
- Understanding of downstream process development and process transfer to manufacturing
- Proven track record of authoring, executing and reviewing both large and small scale validation protocols
- Ability to collaborate with and influence other functional areas such as Regulatory Affairs and Process Validation
- Excellent technical writing skills and oral communication skills
- High energy, results driven individual
- Willingness to be hands on
- Experience performing biologics analytical techniques (HPLC, Capillary Electrophoresis, ELISA)
- Previous management experience
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