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About the role
Key responsibilities & impact- Provide leadership and technical guidance for selection, transfer, and management of new CDMO manufacturing activities.
- Lead current drug substance manufacturing process and optimize for continuous improvement of material.
- Support ongoing CDMO manufacturing activities and troubleshoot issues and non-conformities.
- Determine and resolve gaps for regulatory compliance with drug substance manufacturing and development.
- Support formulation development with drug substance optimization, impurity identification, and pre-clinical study coverage involvement.
- Author and review drug substance IND-enabling protocols, reports, and regulatory submissions.
- Engage and support formulation development with new entity optimization and synthetic route creation/advancement.
- Produce intellectual patent assessments and complete development projects intended for furthering IP generation.
- Other duties as assigned.
Requirements
What you’ll need- PhD, Master’s, or Bachelor’s degree in a physical science field, ideally chemistry, chemical engineering, or biomanufacturing.
- ≥ 8 years in small molecule medicinal chemistry, API development, and/or manufacturing.
- Experienced with early development activities including IND-enabling development and authoring.
- Managed CDMOs for initial development, manufacturing, process validation, and transfer activities.
- Knowledge of analytical technologies including LC, GC, NMR, MS, XRPD, and other relevant methodologies used for elucidation and purity determination.
- Well-informed of FDA, EU, and ICH guidelines for drug substance manufacturing and quality assurance.
- Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
- Strong interpersonal skills for interacting with employees and leaders across various levels and functions.
- Attention to detail and ability to manage multiple processes and documentation requirements.
- Highly organized with documentation associated with project planning, communication, and resulting reports.
- Strong technical and analytical skills with advanced knowledge in ChemDraw, and MS Office including Word, Excel, and PowerPoint.
- Ability to work in a team or independently as required.
- Outstanding organizational skills with the ability to prioritize.
- Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
- Maintain a positive, approachable and professional attitude.
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) match
- Paid time off
- Paid holidays
- Annual performance incentive bonus
- New hire equity package
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug substance manufacturingAPI developmentmedicinal chemistryformulation developmentimpurity identificationIND-enabling developmentprocess validationanalytical technologiessynthetic route creationpatent assessments
Soft Skills
leadershipcommunicationinterpersonal skillsattention to detailorganizational skillsdecision-makingcritical thinkingability to influenceability to prioritizeability to work independently
Certifications
PhDMaster’s degreeBachelor’s degree