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 Development Associate III will be responsible for technical development of Liquid Chromatography (LC) /Mass Spectrometry (MS) based analytical methods for characterizing innovative, antibody based protein molecules at different stages of development. This individual will be responsible for carrying out analyses of biologics, presenting results and authoring technical reports for each project in a timely fashion. He/she will work closely with analytical method development and characterization group in a results-driven, collaborative environment.
Responsibilities and Job Duties
- Develop and execute LC/MS based methods including peptide mapping methods to characterize sequence variants, post-translation modifications and degradation pathways of biologic molecules to support development of analytical control strategy for pipeline programs.
- Operate and maintain HPLC/UPLC/MS analytical instrumentation in compliance with all safety rules and procedures to ensure personal safety and meet required specifications and regulatory requirements.
- Support forced degradation studies, comparability studies, and mass spectrometry based orthogonal analytical characterization methods for mass, size, structure and conformational dynamics of biologics as part of Critical Quality Attribute (CQA) assessment efforts and for supporting regulatory filings.
- Develop and execute high throughput LC based methods to support upstream and downstream processes.
- Support development of product characterization strategy from early to late stage development of biologic molecules.
- Perform analyses working in collaboration with analytical method development and characterization group to determine product CQAs and support Quality by Design like development for pipeline molecules.
- Author technical reports summarizing the characterization results and other technical documentation including standard operating procedures, ensuring timely and accurate completion under minimum supervision.
- Complete documentation to support testing procedures including data capture, forms, logbooks, and inventory batch records.
- Participate in a variety of projects designed to improve the quality, and efficiency of the development team.
Education & Experience
- Bachelor’s in Biochemistry, Chemistry, or life sciences and a minimum of five years of related experience
- Master’s in Biochemistry, Chemistry, or life sciences and a minimum of two years of related experience
Knowledge, Skills and Abilities
- Hands on experience with protein/peptide separations by LC and in-depth characterization by MS, such as peptide mapping, intact mass analysis, and glycan linkage elucidation
- Specific knowledge of mass spectrometry techniques and different related equipment
- Strong expertise in development of reversed phase separation methods for recombinant proteins
- Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements
- Knowledge of ICH guidelines and regulatory requirements for qualification and validation of methods
- Working knowledge of Quality by Design (QbD) based development
- Solid skills in MS Word, Excel, and PowerPoint
- Ability to work well with team members and cross-functional colleagues
- Industrialexperience in developing, qualifying and transferring methods
- Experience performing CQA analysis of antibody based molecules
- Experience drafting analytical sections for IND and BLA filing
- Experience performing multiple analytical comparability studies
- Experience with late stage development
- Experience representing CMC teams in a matrix environment