Associate Director, Analytical Sciences (Method Development And Characterization)

Macrogenics Rockville , MD 20850

Posted 3 weeks ago

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 Associate Director position is a technical and strategic manager responsible for development, qualification, method transfer and full lifecycle support of analytical release methods for biologic products using a variety of scientific processes and methodology. This individual will work closely with other development and quality functions in a results-driven, collaborative environment to support early to late stage development of molecules leading to commercialization. He/she will be responsible for the choice of experimental methodology, carrying out the analyses and providing interpretations and conclusions from the results for each project in a timely fashion. The candidate will work across analytical functions and projects and will also develop technical leaders and provide technical support to other organizations and leadership team.

Responsibilities and Job Duties:

  • Develop analytical release and stability indicating methods including process residuals, physico-chemical, chromatography (size exclusion, Ion-exchange, reversed phase, hydrophobic interaction etc.) and electrophoretic methods (capillary electrophoresis, isoelectric focusing) for biologic pipeline programs to support technical development of the molecules towards commercialization.

  • Lead method lifecycle through qualification and method transfer to quality group. Define strategic goals for the method development and qualification activities.

  • Responsible for developing the analytical control strategy for the pipeline molecules in collaboration with quality function. Ensures that the strategy is in accordance with regulatory guidelines.

  • Oversee comparability evaluations of product quality and stability to support drug substance and drug product process changes.

  • Support development of product characterization strategy approaches from early to late stage development of biologic molecules. These approaches can include use of orthogonal analytical techniques and evaluation of higher order structure through biophysical methods.

  • Co-lead clinical and commercial specification setting activities in collaboration with quality function to support development of analytical control strategy and regulatory filings of pipeline molecules.

  • Lead Critical Quality Attribute (CQA) assessment strategy for supporting regulatory filings. Perform analyses working in collaboration with mass spectrometry and drug product sciences groups to determine product CQAs and support Quality by Design like development for pipeline molecules.

  • Lead forced degradation studies to support CQA assessment and regulatory filings.

  • Supervise operation and maintenance of analytical instrumentation (e.g. HPLC, UPLC, CE, Spectrophotometer, ELISA) and procedures as part of efforts to develop robust analytical method control strategy.

  • Perform analyses to support release and lead lot stability of pipeline programs including drug pre-clinical toxicology animal study batches.

  • Support product quality assessment during cell-culture, purification and formulation development and process characterization efforts from early to late stages.

  • Support application of new cutting-edge technologies to improve throughput for in-process testing and enhance capability of product characterization working with process analytics team.

  • Author technical reports summarizing the method development, qualification, and characterization results and other technical documentation including standard operating procedures for method transfer to quality group as well as guideline documents for implementing best practices.

  • Author analytical sections of IND, BLA and other regulatory documents working with the analytical method development, quality and regulatory groups.

  • Create high-performing teams and supervise direct reports who support these activities. Provide coaching and mentoring to ensure staff development and feedback to maximize productivity and effectiveness.

  • 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 the literature.

  • Ensure understanding of current FDA and ICH guidelines regarding analytical methods to meet regulatory expectations

  • Present scientific findings at internal and external meetings and champion scientific journal publications.

Qualifications

Education & Experience

  • PhD in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 8 years of related industry experience, including 5 years of experience analyzing biological molecules; or

  • Master's degree in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 17 years of related industry experience, including 10 years of experience analyzing biological molecules; or

  • Bachelor's in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 20 years of related industry experience, including 14 years of experience analyzing biological molecules

  • At least 5 years of direct people management experience including coaching and developing a team and providing motivation to accomplish goals and objectives

  • Extensive hands on experience with protein/peptide separations by liquid chromatography (LC) and in-depth protein characterization experience

  • Experience in analytical comparability design and execution, supporting product and process characterization, and early and late stage analytical activities

  • Experience in preparing analytical sections of regulatory documents such as IND, BLA and regulatory discussion documents

Knowledge, Skills and Abilities

  • Specific knowledge of separation and electrophoresis techniques as well as different equipment

  • Ability to supervise operation and troubleshooting of HPLC, UPLC, and CE instrumentation

  • Strong expertise in development and qualification of different separation methods for recombinant proteins

  • Strong protein characterization skills

  • Strong communication and collaborative skills

  • Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements

  • Experience in Critical Quality Attribute (CQA) assessments and Quality by Design based development

  • Ability to manage, train and mentor staff

  • Ability to critically analyze data using statistical tools for product quality monitoring such as control charts and to compile and review technical reports and other documentation

  • Good understanding of statistical tools and knowledge of DOE, process analytical technologies (PAT) and QbD principles

  • Strong communication, presentation, and writing skills

  • Demonstrated skills working collaboratively and cross functionally

  • Strong understanding of CMC functions

Preferred Qualifications

  • Experience in orthogonal characterization techniques for protein mass, size, structure and charge

  • Experience in functional assays including binding (Biacore) and ELISA based bioassays

  • Strong publication and conference presentation record

  • Ability to establish external collaborations and experience in CRO vendor management

  • Ability to formulate and advance strategies

Supervisory Responsibilities

  • Development Associates

  • Scientist(s)

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.


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Associate Director, Analytical Sciences (Method Development And Characterization)

Macrogenics