About Ascendia Pharmaceutical Solutions
Ascendia Pharmaceutical Solutions is a pharmaceutical contract development and manufacturing organization (CDMO) located in North Brunswick, New Jersey. Ascendia partners with pharmaceutical and biotechnology companies to advance drug products from early development through clinical and commercial manufacturing.
Our integrated capabilities support formulation and process development, analytical development, method qualification and validation, stability programs, GMP testing, manufacturing, and regulatory-stage programs.
We are seeking a highly motivated, hands-on Analytical Chemist / Scientist to join our analytical organization and support a diverse portfolio of pharmaceutical development and GMP programs.
Position Summary
The Analytical Chemist / Scientist will perform analytical testing and laboratory activities supporting pharmaceutical development, method development and validation, method transfer, raw material and finished-product testing, stability programs, process development, manufacturing investigations, and GMP release activities.
This is a laboratory-intensive position requiring strong technical capability, disciplined GMP documentation, sound scientific judgment, and the ability to work effectively in the fast-paced, multi-project environment of a pharmaceutical CDMO.
The successful candidate will be comfortable moving between routine analytical execution and scientific problem solving and will understand that generating a chromatogram is only part of the job—the underlying data must be scientifically defensible, traceable, accurately documented, and suitable for regulatory review.
Key Responsibilities
Analytical Testing & Laboratory Execution
- Perform routine and non-routine analytical testing of pharmaceutical raw materials, intermediates, in-process samples, drug substances, drug products, stability samples, and finished products.
- Perform analytical testing using techniques including:
- HPLC/UPLC
- UV-Visible spectroscopy
- Dissolution
- Karl Fischer moisture analysis
- pH
- Assay and related substances/impurities
- Content uniformity
- Wet chemistry and compendial testing
- Other applicable analytical techniques
- Prepare standards, reagents, mobile phases, buffers, and samples in accordance with approved methods and laboratory procedures.
- Execute compendial testing according to applicable USP, EP, JP, and other recognized pharmacopeial requirements.
- Perform calculations, data processing, interpretation, and technical review of analytical results.
Analytical Development & Validation
- Support or independently perform analytical method development, optimization, qualification, validation, verification, and transfer activities.
- Execute method development studies designed to establish method specificity, accuracy, precision, linearity, range, robustness, and sensitivity.
- Support forced-degradation and stability-indicating method development.
- Perform analytical method troubleshooting and investigate unexpected or atypical analytical behavior.
- Support analytical activities associated with formulation and process development studies.
- Participate in analytical method transfer between clients, Ascendia laboratories, and third-party laboratories.
- Prepare and execute analytical protocols and prepare associated technical reports.
GMP & Quality Compliance
- Perform laboratory activities in accordance with current Good Manufacturing Practices (cGMP), approved SOPs, specifications, analytical methods, protocols, and regulatory requirements.
- Maintain complete, accurate, contemporaneous, attributable, and traceable laboratory records in accordance with ALCOA+ data-integrity principles.
- Ensure analytical data, calculations, chromatographic processing, integrations, and supporting documentation are complete and scientifically defensible.
- Participate in investigations involving:
- Out-of-Specification (OOS) results
- Out-of-Trend (OOT) results
- Laboratory deviations
- Atypical results
- Instrument or equipment failures
- Method-related issues
- Support root-cause investigations, impact assessments, corrective and preventive actions (CAPAs), and effectiveness evaluations.
- Identify potential quality or compliance issues and escalate them promptly rather than allowing questionable data or practices to proceed.
- Support inspection and audit readiness activities and participate in client, regulatory, and internal audits when required.
Stability Programs
- Perform analytical testing supporting ICH stability programs.
- Test stability samples according to approved protocols, specifications, and scheduled time points.
- Evaluate stability data for trends, atypical results, degradation patterns, and potential product-quality concerns.
- Support preparation and review of stability reports and associated analytical documentation.
Instrumentation & Laboratory Systems
- Operate, maintain, and troubleshoot analytical instrumentation.
- Support instrument qualification, calibration, preventive maintenance, and periodic review activities.
- Ensure instruments are appropriately qualified and within calibration and maintenance requirements before GMP use.
- Maintain instrument usage logs and associated laboratory records.
- Experience with chromatography data systems such as Waters Empower is strongly preferred.
- Participate in audit-trail review and other applicable data-integrity controls for computerized analytical systems.
Documentation
- Prepare and/or review:
- Analytical test methods
- Specifications
- SOPs
- Method development reports
- Method qualification and validation protocols
- Method validation reports
- Method transfer protocols and reports
- Stability documentation
- Laboratory investigations
- Technical reports
- Ensure documentation is technically accurate, clear, complete, and suitable for GMP and regulatory review.
CDMO & Client Support
- Support multiple client programs simultaneously while maintaining appropriate prioritization and documentation.
- Work collaboratively with Analytical Development, Quality Control, Quality Assurance, Manufacturing, Formulation/Process Development, Project Management, and Regulatory functions.
- Participate in project-team meetings and provide analytical status, results, risks, and recommendations.
- Support technical discussions with clients as appropriate.
- Identify analytical risks or potential schedule impacts early and communicate them clearly to project leadership.
- Work with cross-functional teams to resolve technical issues without compromising scientific or GMP requirements.
Education & Experience
Candidates should possess a degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline, with approximately:
- BS: 3–7+ years of relevant pharmaceutical analytical laboratory experience;
- MS: 1–5+ years of relevant experience; or
- PhD: 0–3+ years of relevant experience.
Equivalent combinations of education and directly relevant pharmaceutical laboratory experience may be considered.
Required Qualifications
- Hands-on pharmaceutical analytical laboratory experience.
- Demonstrated proficiency with HPLC and/or UPLC.
- Understanding of chromatographic principles and troubleshooting.
- Experience performing quantitative pharmaceutical analysis.
- Working knowledge of cGMP laboratory requirements.
- Strong laboratory documentation and data-integrity practices.
- Ability to execute analytical procedures independently after appropriate training.
- Ability to analyze data critically rather than simply report instrument output.
- Strong organizational skills and ability to manage multiple assignments and priorities.
- Strong written and verbal communication skills.
- Ability to work effectively in a multidisciplinary, client-driven CDMO environment.
Preferred Qualifications
Experience in several of the following areas is highly desirable:
- Waters Empower chromatography software
- Dissolution testing
- Karl Fischer titration
- Stability-indicating methods
- Forced degradation studies
- Analytical method development
- Analytical method validation
- Analytical method transfer
- USP/EP compendial testing
- OOS/OOT investigations
- GMP release testing
- ICH stability programs
- Raw material testing
- Drug-product testing
- Cleaning verification/validation analytical support
- Data-integrity and audit-trail review
- Instrument qualification and lifecycle management
- FDA-regulated pharmaceutical development or manufacturing
Experience within a CDMO/CRO environment is particularly valuable because of the need to manage multiple clients, products, methods, timelines, and competing priorities.
Key Competencies
The successful candidate will demonstrate:
- Scientific rigor and intellectual curiosity
- Strong attention to detail
- High standards for data integrity
- Sound technical judgment
- Personal accountability
- Ability to identify and troubleshoot laboratory problems
- Ability to work independently while escalating issues appropriately
- Strong execution and time-management skills
- Comfort operating in a rapidly evolving organization
- Collaborative and client-focused behavior
- Commitment to pharmaceutical quality and patient safety
Work Environment
- Position is 100% onsite at Ascendia Pharmaceutical Solutions in North Brunswick, New Jersey.
- Regular work is performed in pharmaceutical analytical laboratories and GMP-controlled environments.
- Position requires routine handling of laboratory chemicals, solvents, pharmaceutical compounds, analytical equipment, and associated laboratory materials.
- Appropriate personal protective equipment and safety procedures must be followed at all times.
- Occasional schedule flexibility may be required to support manufacturing, stability, client, or project-critical activities.
Why Ascendia?
This position provides an opportunity to work across multiple pharmaceutical programs and stages of development rather than supporting a single product or narrow analytical function.
The Analytical Chemist / Scientist will have direct exposure to pharmaceutical development, analytical sciences, GMP manufacturing, quality systems, client programs, and the transition of products from development toward later-stage and commercial readiness.
For scientists who want to understand how pharmaceutical products actually move from development through manufacturing and ultimately toward the patient, Ascendia offers a technically diverse and highly hands-on environment.
Equal Employment Opportunity
Ascendia Pharmaceutical Solutions is committed to providing equal employment opportunities to qualified applicants and employees without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other status protected by applicable federal, state, or local law.
Job Types: Full-time, Contract, Temporary, Internship
Pay: $40,000.00 - $70,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Education:
Experience:
- Laboratory experience: 1 year (Required)
Ability to Relocate:
- North Brunswick, NJ 08902: Relocate before starting work (Required)
Work Location: In person
