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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analytical method development and validation, regulatory submissions, and team leadership within a cGMP environment. Proven ability to mentor scientists and effectively collaborate across technical and regulatory groups.
Highest-signal resume keywords
PhD In Analytical ChemistryExtensive Experience With UHPLC/HPLCRegulatory Submission AuthoringAnalytical Technology TransfersProject Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Method DevelopmentAnalytical InvestigationsDrug Product TestingStability StudiesSpecification DevelopmentDissolutionGas ChromatographyUV SpectroscopyIR SpectroscopyKarl Fischer Titration
Soft Skills
Problem-SolvingExcellent Communication SkillsInterpersonal SkillsMentoringTeam Collaboration
Tools & Technologies
High-Throughput Experimentation (HTE)LC/MSGC/MSComputational ChemistryData Analysis
Industry Keywords
CGMPChemistry, Manufacturing, And Controls (CMC)INDNDAMAAJNDABioconjugationStructure Based Drug DesignSynthetic ChemistryResearch Proposal Development
About the role
Key responsibilities & impact- Lead a team of scientists in analytical method development and validation, drug product testing, and analytical investigations in a cGMP environment
- Oversee drug product and manufacturing process characterization, stability studies, and specification development
- Support manufacturing process scale-up and validation
- Prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions and respond to regulatory questions
- Collaborate with technical, regulatory, research, and manufacturing groups
- Coordinate drug product development efforts and lead progress for multiple projects
- Mentor other scientists and build/maintain the scientific capabilities of the organization
Requirements
What you’ll need- PhD in Analytical Chemistry or related discipline with seven or more (7+) years of relevant small molecule pharmaceutical development experience; OR MS with ten or more (10+) years
- Strong background and extensive hands-on experience with UHPLC/HPLC, Dissolution, Gas Chromatography, UV and IR spectroscopy, and Karl Fischer titration
- Extensive experience with method development and validation
- Significant experience authoring relevant CTD sections of regulatory submissions (IND, NDA, MAA, JNDA, etc.)
- Demonstrated problem-solving ability
- Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
- Ability to work in a team environment with cross-functional interactions
- Experience in mentoring and leading teams
- Significant experience in analytical technology transfers
- Demonstrated effective planning and execution of regulatory strategies
- Preferred: Experience with hyphenated analytical techniques such as LC/MS and GC/MS with proven ability in troubleshooting these methodologies
- Required skills: Academic Presentations, Bioconjugation, Computational Chemistry, Data Analysis, High-Throughput Experimentation (HTE), Organic Synthesis, Professional Networking, Project Leadership, Research Proposal Development, Scientific Leadership, Scientific Literature Search, Strategic Thinking, Structure Based Drug Design, Synthetic Chemistry
- Visa sponsorship is available
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Visa sponsorship
- Domestic relocation