Associate Director, Cmc Analytical Development

Position Summary

Associate Director, CMC Analytical Development at Constellation will be responsible to lead and manage all Analytical Development and routine testing activities relating to drug substance and drug product testing.

Telecommuting permitted from anywhere within continental U.S.

Job Duties:

• Develop and write analytical methods, protocols, and reports that comply with ICH guidelines and FDA requirements using principles of pharmaceutical science;
• Analyze quality control test results and provide quality control data to production management or staff;
• Develop robust, stability-indicating analytical procedures to support drug life cycle;
• Direct active ingredient and drug product testing activities throughout production cycles;
• Responsible for method development and validation work, batch release, stability, specification, and Out-Of-Spec (OOS) / Out-Of-Trend (OOT) investigations at various Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) with certain challenging timelines to ensure that uninterrupted clinical supply needs are met;
• Verify that raw materials, in-process samples, active ingredients and finished drug products meet established testing and inspection standards;
• Serve as subject matter expert in various analytical techniques to troubleshoot analytical methods, phase-appropriate validations, qualifications, and transfers at various CDMOs;
• Oversee multiple projects at various CDMOs and CTLs; Understand how analytical projects feed into overall CMC drug development;
• Monitor performance of quality control systems to ensure drug effectiveness and drug safety;
• Direct the tracking of defects, test results, or other regularly reported quality control data;
• Implement learning and challenges gained at CDMOs for successful completion of method development, validation, qualification, and transfer at various CDMOs and CTLs in compliance with Current Good Manufacturing Practices (cGMP);
• Participate, draft, and review analytical sections of regulatory filings;
• Oversee analytical method implementation, validation, qualification, transfer, and stability program at various CDMOs and CTLs; provide technical updates to the internal team in timely manner;
• Review quality documentation necessary for regulatory submissions and inspections;
• Review and update standard operating procedures and/or quality control manuals; and
• Instruct staff regarding quality control and analytical procedures;

If telecommuting, travel required (approx. 5%) to Constellation’s headquarters in Boston, MA.

Associate Director, Analytical Development CMC will report directly to Constellation’s Director, CMC Analytical Development & Quality Control, and indirectly to its SVP, Head of CMC (Small Molecule).

Minimum Education/Skills/Experience

• Master’s degree (or foreign equivalent) in Pharmaceutical Sciences or Manufacturing, Chemical Science, Biological Science, or a closely related life sciences field, plus
• 3 years of experience as an Analytical Development Scientist or Manager, or related Analytical Development role in the biotechnology or pharmaceutical industries;

AND EXPERIENCE MUST INCLUDE THE FOLLOWING, WHICH MAY HAVE BEEN GAINED CONCURRENTLY:

• 3 years of experience with small molecule analytical science;
• 3 years of experience using modern analytical chemistry techniques, including chromatography, mass spectrometry, particle size analysis, wet chemistry, and thermal analysis;
• 3 years of experience managing technical aspects of projects;
• 3 years of experience working directly in a contract development and manufacturing organization (CDMO) environment;
• 3 year of experience contributing to analytical sections for regulatory filings to health authorities, including responding to health authorities’ questions;
• 3 years of experience presenting project updates, including the status of analytical activities;
• 3 years of experience with management and organization of controlled documents (such as certificates of analysis, stability data tables and/or validation protocols/reports); and
• Experience leading or managing external CDMOs and CTLs for outsourced activities.

Culture & Benefits

As a full time, employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more. We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program. Our culture is a collaborative work environment, and we believe the unique contributions each of us brings drives our success

EEOC Statement

MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices. We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.