Associate Director, Technical Operations
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.
Constellation is entering late-stage clinical trials and preparing for commercialization and launch of its lead product candidate. We are #BrighterTogether
How you will spend your day:
- 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 scale-up, technology transfers, troubleshooting of process-related issues.
- Review analytical protocols and methods suitable for progressive stages of pharmaceutical development and track analytical activities.
- Timely monitor and evaluate release and stability data from CDMOs for GMP compliance, potential out of specification, out of trend, and method performance issues and conduct investigations and implement corrective actions as needed
- Serve as the point person with contract manufacturing and testing labs.
- Ensure timely delivery of clinical trial materials to support various stages of clinical studies.
- 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 manufacture of registrational stability batches and process validation
- Participate in preparation, review, and approval of CMC sections for regulatory filings
- 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 (circa 20%)
Key Things About You:
- 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
- A minimum of 8 years (including 3+ years of hands-on) experience in relevant small molecule formulation and process development for Oral Products.
- Technical depth in formulation development and process development involving roller compaction, high shear granulation, fluid bed drying, milling, blending, tablet compression and film coating operations
- 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
- Successful experience in managing CDMOs and oversight of cGMP manufacturing activities
- Demonstrated ability in leading CMC teams and delivering on CMC project activities
- 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
- Proficient in authoring and reviewing of the CMC sections of the regulatory dossiers
- Organized, detail-oriented and efficient with a desire to work in a fast-paced, dynamic environment
- Independent & accountable
Don’t see the position you’re looking for? We want to hear from you regardless! Please submit your CV to us at firstname.lastname@example.org
Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.