Sr. Manager, CMC Analytical Development & Quality Control
At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.
Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.
Our headquarters are in Planegg, Germany and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at MorphoSys.com, and follow us on LinkedIn and Twitter.
Morphosys seeks an experienced and highly motivated CMC Senior Manager to join its Small Molecule CMC team based in Boston, MA. The ideal candidate will have a strong background in CMC disciplines and especially in analytical sciences and manufacturing. Additionally, the successful candidate will have broad experience in the creation and execution of product development strategies to advance and support our small molecule portfolio from late clinical development to commercialization (including NDA filings). Candidates who are enthusiastic team players and have a passion for playing a key role in the development of life-saving medicines are encouraged to apply.
- Work closely with the CMC team and Contract Development & Manufacturing Organizations (CDMOs) towards reviewing analytical protocols and methods for optimization, qualification in a compliance-based environment and in a timely manner to meet program timelines
- Contribute to technical documents such as test methods, reports, protocols, and internal presentations
- Work closely with CDMOs to validate and transfer (as applicable) analytical methods, suitable for progressive stages of pharmaceutical development and/or supervise activities
- Work closely with CDMOs to design stability studies for drug substance and drug product
- Serve as the direct contact with contract manufacturing and testing labs
- Timely monitor and evaluate release and stability data from CMOs and CROs for GMP compliance, potential out of specification, out of trend, and method performance issues and supervise or conduct investigations and implement corrective actions as needed
- Present to cross functional teams and effectively communicate critical analytical issues and solutions
- Develop, review, and approve source documents for regulatory submissions
- Assist in the design of validation protocols that are in compliance with ICH and FDA guidelines, and identify critical factors that may not be mandated by the guidelines but are essential for validating the methods for their intended use
- Advanced degree with 5+ years of relevant analytical development experience
- Broad understanding of the drug development process, including toxicology, regulatory filings, chemical development, solid state development, and formulation development, and the interrelationship with analytical development is essential
- Understanding on how to set and justify drug substance and drug product specifications with the understanding of clinical study design and CMC processes
- Ability to justify and set retest period, storage, and shipping conditions
- Good understanding of ICH, FDA, and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
- Excellent verbal and written communication skills are essential
- Skilled in HPLC, LC-MS, GC, GC-MS, FT-IR, UV-VIS, KF, NMR, dissolution, and broad knowledge of other techniques used in pharmaceutical analysis
- The ability to work successfully in both a team/matrix environment as well as independently is required
- Analytical and Problem-Solving Skills - Able to troubleshoot routine issues or problems using appropriate information
- Desire and ability to work in a fast paced, cross-functional, flexible and team-oriented environment.
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
Health and Safety
Full vaccination against COVID 19 is a requirement for this position.
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.
MorphoSys is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at email@example.com