Manager, Biologics Analytical Development

Employer
Location
Waltham, MA
Salary
Competitive salary and benefits
Posted
Jun 02, 2018
Closes
Jul 02, 2018
Education
MS, PHD
Career Fair Category
Career Fair

Manager, Biologics Analytical Development

There is nothing conditional about what we do.

Or who we are.

Or how we treat you.

We do what’s right.

We put science for patients first,

disrupting the model to go beyond

the concepts of conventional care.

We don’t treat a condition.

We treat people & partners.

We care to change the future.

Your Impact at TESARO:

The Manager, Biologics Analytical Development will be a highly experienced, motivated and team-oriented individual for an important role supporting development and registration of the company’s pipeline of preclinical- and development-stage immuno-oncology candidates.  The successful candidate will lead product characterization and CQA assessment, while setting scientifically justifiable comparability strategies. The candidate will lead a cross-functional team to develop characterization strategies and guidelines for integrated early and late stage analytical development activities in support of biologics commercialization.

Job Responsibilities:

  • Manage and oversee analytical activities performed at CROs/CDMOs associated with method development and characterization for drug substance, drug product and reference standards.
  • Execute the strategies for product characterization with a focus on CQA assessment, and lead characterization activities at CROs/CDMOs.
  • Collaborate with process, formulation, and QC functions to ensure strong cross functional collaborations and integrated process and product development and characterization.
  • Author, review and/or approve key documents such as: comparability protocols and reports,

    and relevant sections of regulatory filings (IND, IMPD, BLA, etc.).

  • Implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.

Requirements:

  • Ph.D. or M.S.in chemistry, biology, biochemistry, or biochemical/bioprocess engineering or related technical discipline. Minimum of 7 years (for Ph.D.) or 11 years (for M.S.) of biopharmaceutical analytical experience with recombinant biologic modalities and exposure to all stages of biologics drug development.
  • Significant experience in the biopharmaceutical industry with relevant experience in late stage product characterization, CQA assessment and process characterization for therapeutic proteins /mAbs.
  • Theoretical and hands-on knowledge and experience with methods used for biopharmaceutical characterization including HPLC based separation methods, peptide mapping, mass spectrometry, electrophoresis and other physicochemical technologies.
  • Experience with product characterization and assay development for novel molecules (antibody drug conjugates, bi-specifics, fusion proteins, peptides etc.) desired.

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

FOR MORE INFORMATION, PLEASE CONTACT US AT careers2@tesarobio.com