Director, Technical Operations (Oral Products)
The Director, Technical Operations (Oral Products) is a newly created role in our Research and Development team and will spearhead the successful development of drug substance, drug product and analytical development of pipeline projects. 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. We are #BrighterTogether
How you will spend your day:
- You will design and develop oral products and related manufacturing processes including scale-up, technology transfers, troubleshooting of process-related issues.
- You will ensure that drug product development and manufacturing timelines and budgets are met.
- You will develop proposals in collaboration with external vendors and ensure implementation
- Managing Contract Development and Manufacturing Organizations (CDMOs), including selection, planning and reviewing technical content, ensuring budget and timelines are achieved, and making data-driven decisions for the project
- Reviewing and approving documents related to GMP operations as requested including DP development report, MBRs, EBRs, and campaign summary report.
- Overseeing the implementation of process improvements into drug product CMOs
- Supporting the late-stage product development activities including manufacture of registrational stability batches and process validation
- You will participate in preparation, review, and approval of CMC sections of regulatory filings
- Participating in periodic business and technical review meetings with relevant DP CMOs
- Clearly communicate progress and collaborate with internal cross-functional development teams to ensure alignment with overall asset development and filing plans
- You will travel to various sites (circa 20%)
Key Things About You:
- You will ideally hold a Ph. D. in Chemical Engineering, Pharmaceutical Sciences or related disciplines however MS degree candidates with substantial direct experience in CMC will be considered
- You can offer a minimum 8 years of experience of relevant small molecule CMC development
- You will have demonstrated experience in leading CMC teams
- Technical depth in formulation and process development
- You will have experience in managing CDMOs and oversight of cGMP manufacturing activities
- Demonstrated ability to deliver on CMC project activities
- Understanding of the drug development process including Regulatory and Quality requirements
- Strong project management, interpersonal, and communication skills
- Ability to partner with the business functions in order to enable high-quality outcomes
- You are proficient in the authoring and reviewing of the CMC sections of regulatory dossiers
- You have a desire to work in a fast-paced, dynamic environment
- Excellent communication and presentation skills
- Team player; experienced at developing talent
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; delivers high-quality work
- You are flexible to domestic and international travel circa 20%
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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.