CMC Analytical Development Manager
The CMC Analytical Development Manager is a newly created role in our Research & Development team. The new team member will gain experience in late-stage methods development and will be involved with both drug substance and drug product development as we prepare to begin Phase III development. At Constellation we are #BrighterTogether
The ideal candidate will have a strong background in CMC disciplines and especially in analytical sciences and manufacturing. Additionally, the successful candidate will have experience contributing to the creation and execution of product development strategies to advance and support our small molecule portfolio from preclinical projects in IND enabling studies through late clinical development (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.
How you will spend your day:
- You will work closely with the CMC team and Contract Development & Manufacturing Organizations (CDMOs) towards reviewing analytical protocols and methods for compliance-based environment with adherence to compliance optimization, qualification in a virtual, program timelines
- You will contribute to technical documents such as test methods, reports, protocols, and internal presentations
- Work closely with CDMOs to develop, validate, and transfer phase-appropriate analytical methods and 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 CDMOs 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
- Manage reference standard qualification and retest activities
Key Things About You:
- You will hold an advanced degree with 4+ years of relevant GMP analytical development experience
- You will have a 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
- You have an understanding of 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
- Demonstrated leadership skills and 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 small molecule pharmaceutical analysis
- Experience with impurity identification and Regulatory Starting Material justification studies
- Experience working at a CDMO
- The ability to work successfully in both a team/matrix environment as well as independently is required
- You have strong analytical and problem-solving skills and are able to troubleshoot routine issues or problems using appropriate information
- You have a desire and ability to work in a fast-paced, cross-functional, flexible and team orientated environment.
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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.