The ideal candidate will have a Ph.D. and 8–15 years of industry experience, with expertise in analytical method development, validation, troubleshooting, stability programs, CMC strategy, and GMP compliance. Experience with HPLC/UHPLC, LC-MS/MS, GC, SEC, DLS, sterile injectables, lyophilized products, or novel excipients is highly valued. This is a hands-on leadership role requiring CRO/CMO oversight, regulatory filing support, team building, and the ability to work directly at the bench in a fast-moving biotech environment.
Industry: Clinical Diagnostics / Genetics / Molecular Cytogenetics
Location: Dover, DE
Type: Direct Hire
The Director of Analytical Services is a hands on CMC analytical leader responsible for running analytical development and QC capabilities to support our oncology pipeline from early development through clinical stages and eventual commercialization. This role combines strategic ownership of analytical control strategy with direct laboratory execution, vendor oversight, and cross functional leadership typical of a small, fast moving biotech environment.
The Director will establish analytical methods, systems, and workflows, ensuring phase appropriate rigor, regulatory compliance, and efficient use of internal and external resources. This position is ideal for a leader who thrives in a startup style environment, enjoys solving multidisciplinary problems, and is comfortable switching between high level CMC strategy and bench level execution.
Key Job Elements
Analytical Strategy & Execution
- Own the analytical control strategy for drug products and novel excipients across all phases.
- Develop, qualify, validate, and troubleshoot analytical methods (HPLC/UHPLC, LC?MS/MS, GC, SEC, DLS, solid state, microbiological, etc.).
- Design and execute forced degradation, stability indicating method development, and characterization studies.
- Establish practical, phase appropriate specifications and update them as programs mature.
Hands?On Laboratory Leadership
- Work directly at the bench (10–30% depending on phase) to develop methods, generate data, and mentor scientists.
- Oversee day to day lab operations, instrument strategy, qualification, and troubleshooting.
CRO/CMO Oversight
- Lead method transfers, qualifications, and ongoing oversight of CROs and CMOs.
- Ensure data integrity, technical alignment, and timely delivery of outsourced analytical work.
- Participate in vendor audits and selection.
Regulatory & CMC Ownership
- Serve as analytical lead for IND/IMPD filings and contribute to NDA/DMF content.
- Draft and review analytical sections of Module 3.
- Support responses to FDA/EMA information requests and inspection readiness.
Quality, Compliance & Data Integrity
- Ensure adherence to GMP, ICH, and FDA expectations appropriate for clinical stage biotech.
- Implement practical data integrity controls, documentation standards, and 21 CFR Part 11 practices.
- Lead OOS/OOT investigations, CAPA and analytical improvements.
Stability & Specifications
- Own stability program design, execution, and trending.
- Manage reference standard qualification and lifecycle.
- Establish and maintain phase appropriate specifications.
Team Building & Leadership
- Build and mentor a small, high impact analytical team.
- Provide hands on training, technical guidance, and career development.
- Create a culture of scientific rigor, urgency, and accountability.
Safety & Lab Infrastructure
- Ensure safe operation of analytical labs and compliance with chemical/biological safety requirements.
- Support safety committee activities and continuous improvement of safety practices.
Knowledge/Experience
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 8–15 years of industry experiences.
- Demonstrated success in leading analytical development.
- Expert in method development, validation, and troubleshooting across major analytical platforms.
- Strong understanding of sterile injectable and/or nanoformulation analytical challenges a plus.
- Experience supporting IND/DMF/NDA filings and interacting with regulatory agencies.
- Ability to operate effectively in a fast changing environment.
- Hands on leader comfortable working at the bench while driving strategy.
- Strong documentation, communication, and crossfunctional collaboration skills.
Preferred
- Experience with oncology injectables, lyophilized products, and novel excipients.
- Experience building analytical labs, systems, or teams.
- Familiarity with QbD principles and analytical lifecycle management.
- Ability to manage multiple programs and shifting priorities typical of small biotech.
Estimated Min Rate: $161000.00
Estimated Max Rate: $230000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
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