Development Scientist I/II - Analytical Sciences (Product Characterization)

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

Qualifications:

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

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

Additional Information

The annual rate of pay for this position ranges from $98,600 to $152,900 (Development Scientist I) and $106,500 to $165,100 (Development Scientist II). For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

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

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.