MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.
MacroGenics is a bold, highly engaged, and diverse team driven by a passion for improving the lives of patients through innovative science. We are committed to an inclusive workplace built on trust and respect. We value and nurture strong connections with one another and foster collaborative relationships. We empower our people and drive personal accountability. We encourage curiosity and embrace our entrepreneurial spirit. We celebrate our successes and create a learning environment where all employees can thrive!
Summary of Position
The Scientist I/II is a hands-on laboratory position within the Analytical Sciences group responsible for development and execution of liquid chromatography (LC) /mass spectrometry (MS) based analytical methods used for characterizing antibody-based molecules at different stages of development. This individual will work closely with other teams within the Analytical Sciences group in a results-driven, collaborative environment. They will be responsible for the choice of experimental methodology, carrying out the analyses, and providing interpretations and conclusions in a report form in a timely fashion. They are expected to train other analysts on analytical methods and techniques as needed.
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 biologics pipeline programs.
- Support development of product characterization strategy from early- to late-stage development of biologic molecules.
- Support forced degradation studies and comparability studies to support CQA assessment and regulatory filings.
- Develop 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.
- Operate and maintain analytical instrumentation including mass spectrometry instruments.
- Ensure all work meets or exceeds safety standards and applicable regulatory guidelines.
- Author technical reports summarizing the characterization results and other technical documentation including standard operating procedures.
- Support analytical sections of IND, BLA, and other regulatory documents working with the analytical method development, quality, and regulatory groups.
- Present study conclusions at internal and external scientific meetings.
- Serve as an analytical resource for the department and project teams proactively keeping colleagues updated with current scientific trends and technical aspects from conferences, local meetings, and literature.
- Establish strong collaboration with other groups within the Biopharmaceutical Development department.
Qualifications
Development Scientist I
Education & Experience
- Bachelor's in Biochemistry, Chemistry, or life sciences and a minimum of 8 years of related experience or
- Master's in Biochemistry, Chemistry, or life sciences and a minimum of 6 years of related experience or
- PhD in Biochemistry, Chemistry, or life sciences and 0 years of related experience
Development Scientist II
Education & Experience
- Bachelor's in Biochemistry, Chemistry, or life sciences and a minimum of 11 years of related experience or
- Master's in Biochemistry, Chemistry, or life sciences and a minimum of 9 years of related experience or
- PhD in Biochemistry, Chemistry, or life sciences and 3 years of related experience
- A minimum of 2 years of industrial experience working on LC/MS methods.
- Experience representing CMC teams in a matrix environment.
- Experience with developing biologics at early or late stage leading into commercial launch.
- Experience in orthogonal characterization techniques for protein mass, size, structure, and charge.
Knowledge, Skills and Abilities
- Hands-on experience and knowledge of mass spectrometry techniques.
- Strong protein characterization skills.
- Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
- Strong communication, presentation, and writing skills.
- Demonstrated skills working collaboratively and cross-functionally.
- Ability to drive innovation and champion implementation of best practices.
- Knowledge of ICH guidelines and regulatory requirements.
Preferred Qualifications
- Minimum 1-2+ years of industrial experience working on LC/MS methods is preferred.
- Experience with developing biologics at early or late stage leading into commercial launch.
- Experience in Critical Quality Attribute (CQA) assessments and Quality by Design based development.
- Experience in drafting analytical sections of regulatory documents related to IND and IMPD.
- Experience in supporting analytical sections of regulatory documents related to BLA.
- Experience in orthogonal characterization techniques for protein mass, size, structure, and charge.
- Experience representing CMC teams in a matrix environment.
Supervisory Responsibilities
None
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 or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
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