Principal Scientist - Analytical Development (Small Molecule)
COMPANY SUMMARY
A leading global contract development and manufacturing organization (CDMO) providing drug substance development and manufacturing support across the full drug lifecycle, along with comprehensive analytical and IND‑enabling services.
With over 40 years of experience and a 2,000‑person expert team supporting global clients, the organization offers specialized drug substance technologies including continuous flow, controlled substances handling, liquid‑phase peptide synthesis, solid‑state science, material characterization, and highly potent API manufacturing.
COMPANY CULTURE
The company fosters a culture where employees can:
- Engage in impactful work supporting customers and the patients they serve
- Learn new skills and gain hands‑on experience in a safe, supportive environment
- Strengthen connections with colleagues and the broader community
They are committed to attracting and developing talented professionals in a fast‑paced, growing organization, offering competitive benefits including healthcare, life insurance, retirement planning, and more.
JOB SUMMARY
The Principal Scientist I will provide technical support across multiple project teams. Responsibilities include evaluating and interpreting analytical data, developing/validating analytical methods, and transferring those methods for APIs, intermediates, and raw materials. Strict adherence to cGMP guidelines is required.
RESPONSIBILITIES
- Develop, establish, and validate analytical testing methodologies for raw materials, intermediates, and final products
- Participate in cross‑functional teams to troubleshoot and resolve analytical technical issues
- Perform analytical chemistry assays using new and established methods
- Operate analytical instruments such as HPLC, GC, GC/MS, FTIR, titrators, and particle size analyzers
- Author technical reports documenting analytical methods
- Maintain compliant laboratory notebooks
- Ensure adherence to GMP SOPs and regulatory requirements
- Transfer analytical methods to Quality Control and process support teams
- Establish analytical methods for identification, purity, and potency testing
- Coordinate off‑site testing when necessary
- Conduct analytical testing to support process development activities
- Qualify reference materials
- Perform additional duties as assigned
QUALIFICATIONS
Technical Competencies
- Demonstrated growing expertise in analytical chemistry and method development
- Broad understanding of cross‑functional disciplines including organic chemistry and engineering
- Understanding of GMP regulations and ability to apply them to development programs
- Advanced proficiency with HPLC, GC, MS instruments; ability to train others and troubleshoot issues
- Strong written and verbal communication skills, including client‑facing interactions
- Strong problem‑solving capability and ability to lead investigations
- Effective time management and ability to independently progress projects
- Emerging leadership skills with a focus on knowledge‑sharing and initiative‑building
- Ability to author and review technical documentation with minimal errors
- Ability to influence project team direction and support clients toward optimal outcomes
- Recognized as a scientific leader locally within the organization
- Active participation in operational excellence and organizational change initiatives
Educational Requirements
- Ph.D. in Chemistry or related field with 8+ years experience
OR - M.S. in Chemistry or related field with 10+ years experience
OR - B.S. in Chemistry or related field with 12+ years experience (pharmaceutical experience preferred)
Additional Skills
- Demonstrated ability to transfer processes to commercial‑scale manufacturing
- Strong communication, interpersonal, and organizational skills
- Ability to work effectively in diverse, cross‑functional environments
ADDITIONAL INFORMATION
- Employment offers are contingent upon successful completion of a pre‑employment screening process, which may include drug testing, criminal background checks, identity verification, reference checks, and verification of education and employment history. Requirements may vary based on federal, state, and local regulations. Failure to complete screening will result in disqualification.
- Can support a Sponsorship
FAQs
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