Associate Director Technical Operations, Drug Product
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.
The Associate Director, Technical Operations is a newly created role in our Research and Development team and will spearhead the successful development of small molecule drug product. Individuals who are self-motivated, enthusiastic team players with a passion for playing a key role in the development of life-saving medicines are encouraged to apply. Expertise in oral formulation and process development is required.
- Manage Contract Development and Manufacturing Organizations (CDMOs), including developing proposals, selection, planning, budgeting, timely execution and making data-driven decisions for the project
- Design and develop oral products and related manufacturing processes including mid- & late stage development activities
- Ensure timely delivery of clinical trial materials to support various stages of clinical studies
- Support QA in in developing & executing change controls
- Review and approve documents related to GMP operations as requested including DP development report, Master Batch Records, Executed Batch Records, campaign summary reports and stability summary reports.
- Support late-stage product development activities including design and execution of formulation & manufacturing process characterization, registrational stability and manufacturing process validation protocols and reports
- Compile summary of actual process parameters and lot genealogy utilized for all development and clinical drug product batches
- Participate/lead in the preparation, review, and approval of NDA drug product source documents and drug product CMC sections for regulatory filings
- Serve as the point person with contract development and manufacturing organizations (CDMOs)
- Timely monitor and evaluate release and stability data from CDMOs and support potential out of specification, out of trend, and method performance issues and related investigations and implement corrective actions as needed
- Participate in periodic business and technical review meetings with relevant DP CDMOs
- Clearly communicate progress and collaborate with internal cross-functional development teams to ensure alignment with overall asset development and filing plans
- Travel to various CDMO sites, as necessary
- Ideally hold a Ph. D. in Pharmaceutical Sciences, Chemical Engineering or related disciplines however MS degree candidates with substantial direct experience in CMC will be considered
- 8+ years (including 3+ years of hands-on) experience in relevant small molecule formulation and late-stage manufacturing process development for Oral Products
- Technical depth in formulation development and manufacturing process development involving roller compaction, high shear granulation, fluid bed drying, milling, blending, tablet compression and film coating unit operations
- Demonstrated experience in late-stage development including design and execution of protocols for scale-up, manufacture of registration stability batches, and process validation
- Successful experience in managing CDMOs and oversight of cGMP manufacturing activities in virtual fashion
- Demonstrated ability in leading CMC teams and delivering on CMC project activities
- Proficient in authoring and reviewing NDA drug product source documents and drug product CMC sections of the regulatory dossiers; experience/expertise in working within Veeva is a plus
- Understanding on how to set and justify drug substance and drug product specifications with the understanding of clinical study design and CMC processes
- Understanding of the drug development process including Regulatory and Quality requirements
- Team player with strong project management, interpersonal, communication and presentation skills
- Ability to partner with the business functions in order to enable high-quality outcomes
- Ability to justify and set retest period, storage, and shipping conditions
- Organized, detail oriented and efficient with a desire to work in a fast-paced and dynamic environment
- Independent & accountable
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 flex time off program 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