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# Director of Analytical Chemistry


Role Overview for Director of Analytical Chemistry
JRG Partners is proud to partner with a trailblazing biotechnology and pharmaceutical client, a leader in developing innovative therapeutics that are transforming patient lives. We are actively seeking a highly accomplished and visionary Director of Analytical Chemistry to join their dynamic R&D team in Boston, MA. This is an unparalleled opportunity for a seasoned scientific leader to significantly impact the drug discovery and development lifecycle, from early-stage research through commercialization.
As the Director of Analytical Chemistry, you will be at the helm of a critical function, responsible for providing strategic direction, scientific leadership, and operational oversight for all analytical chemistry activities. Your expertise will be instrumental in guiding the development, validation, and implementation of cutting-edge analytical methods for small molecules, biologics, and novel drug candidates. This role demands a leader who can not only drive scientific excellence and innovation but also foster a collaborative and high-performing team environment. You will play a pivotal role in ensuring the quality, purity, and stability of our client’s diverse pipeline, making a direct contribution to bringing life-changing medicines to patients.
Our client fosters an environment of intellectual curiosity, scientific rigor, and a commitment to pushing the boundaries of what’s possible in healthcare. The successful candidate will be a proactive problem-solver, an exceptional communicator, and a strategic thinker capable of navigating complex scientific challenges and regulatory landscapes. This role offers the chance to build and mentor a world-class team, integrate advanced analytical technologies, and shape the future of analytical science within a rapidly growing and impactful organization.
If you are a passionate leader with a deep understanding of analytical chemistry, a proven track record in the biopharmaceutical industry, and a desire to make a tangible difference, we invite you to explore this exciting opportunity. Join us in shaping the next generation of medicines.
Key Responsibilities of Director of Analytical Chemistry
The Director of Analytical Chemistry will be entrusted with a comprehensive set of responsibilities critical to the success of our client’s research and development initiatives. These responsibilities are designed to ensure scientific excellence, regulatory compliance, and efficient operational execution across all analytical functions:
Strategic Leadership & Vision
Develop and implement a robust analytical strategy aligned with the company’s overall R&D goals and product pipeline. Provide scientific leadership and technical expertise in analytical chemistry, influencing decision-making across various departments.
Method Development & Validation Oversight
Lead and oversee the development, optimization, transfer, and full validation of a wide range of analytical methods (e.g., HPLC, GC, LC-MS, GC-MS, NMR, IR, UV-Vis, Karl Fischer, dissolution, particle size analysis, electrophoresis, immunoassay) for drug substances, drug products, raw materials, and in-process samples. Ensure methods are fit-for-purpose and compliant with regulatory requirements.
Team Management & Development
Recruit, mentor, train, and manage a team of highly skilled analytical chemists and scientists. Foster a culture of scientific rigor, continuous improvement, innovation, and professional growth within the department. Conduct performance reviews and support career development plans.
Regulatory Compliance & Quality Assurance
Ensure all analytical activities, documentation, and data generated adhere strictly to cGMP, GLP, ICH, FDA, EMA, and other relevant international regulatory guidelines. Oversee the generation of data packages for regulatory submissions. Actively participate in regulatory audits and inspections. A critical aspect of this role involves ensuring robust regulatory compliance, particularly concerning the validation of analytical procedures according to ICH guidelines.
Instrumentation & Technology Management
Oversee the selection, qualification, maintenance, calibration, and troubleshooting of state-of-the-art analytical instrumentation. Evaluate and implement new analytical technologies and methodologies to enhance capabilities, efficiency, and data quality.
Quality Systems & Investigations
Drive the establishment and continuous improvement of quality systems within the analytical department, including managing Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation investigations. Implement effective Corrective and Preventive Actions (CAPAs).
Cross-functional Collaboration
Serve as a key analytical expert and collaborate extensively with R&D, Process Development, Formulation, Quality Control, Quality Assurance, Regulatory Affairs, and Manufacturing teams to support project progression from early discovery through commercialization.
Budget & Resource Management
Effectively manage the departmental budget, allocate resources, and prioritize projects to meet aggressive timelines and strategic objectives. Optimize laboratory operations for efficiency and cost-effectiveness.
Data Interpretation & Reporting
Oversee the accurate interpretation, statistical analysis, and comprehensive reporting of complex analytical data. Ensure data integrity and robust documentation practices.
Vendor & CRO Management
Manage relationships with external contract research organizations (CROs) and analytical service providers, overseeing outsourced analytical work and ensuring quality and compliance.
Safety & Environmental Compliance
Ensure all laboratory operations are conducted in accordance with established safety protocols and environmental regulations.
Requirements for the Director of Analytical Chemistry
To excel in this pivotal leadership role, candidates must possess a unique blend of advanced scientific knowledge, extensive industry experience, and exceptional leadership capabilities. Our client is seeking a dynamic individual who can inspire a team and drive analytical innovation.
Education:



Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline is required.



Experience:



Minimum of 10-15 years of progressive experience in analytical chemistry within the pharmaceutical, biotechnology, or a highly regulated contract research organization (CRO) environment.
At least 5-7 years of demonstrated experience in a leadership or management role, leading and mentoring a team of analytical scientists and associates.
Extensive experience in drug development, from early-stage discovery through late-stage clinical development and commercialization.



Technical Expertise & Skills:
Comprehensive Analytical Knowledge
Deep theoretical and practical understanding of a broad range of analytical techniques, including but not limited to: high-performance liquid chromatography (HPLC), gas chromatography (GC), liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS), nuclear magnetic resonance (NMR), infrared (IR) spectroscopy, UV-Vis spectroscopy, Karl Fischer titration, dissolution testing, particle size analysis, electrophoresis, and various immunoassay techniques.
Method Development & Validation Mastery
Expert-level knowledge and hands-on experience in the design, development, optimization, transfer, and full validation of analytical methods for both small molecules and biologics.
Regulatory Acumen
In-depth understanding and practical application of global regulatory guidelines (e.g., FDA, EMA, ICH, USP, EP) pertaining to analytical method development, validation, stability testing, impurity profiling, and quality control in a cGMP environment.
Data Analysis & Statistics
Strong proficiency in statistical analysis of analytical data, including method validation statistics, stability data analysis, and OOS/OOT investigations. Familiarity with statistical software packages.
Instrumentation Expertise
Proven ability to oversee the qualification, maintenance, and troubleshooting of complex analytical instrumentation.
Quality Systems Experience
Demonstrated experience with pharmaceutical quality systems (e.g., LIMS, EDMS, QMS), including managing deviations, OOS/OOT investigations, and CAPA implementation.
Leadership & Soft Skills:
Exceptional Leadership
Proven ability to lead, motivate, inspire, and develop high-performing scientific teams. Strong mentorship and coaching skills.
Strategic Thinking
Capacity to develop long-term analytical strategies that align with business objectives and anticipate future scientific and regulatory needs.
Problem-Solving
Outstanding analytical and critical thinking skills with a proactive approach to identifying and resolving complex scientific and operational challenges.
Communication
Superior written and verbal communication skills, with the ability to articulate complex technical information clearly and concisely to diverse audiences, including senior management, regulatory bodies, and cross-functional teams.
Collaboration
Demonstrated ability to work effectively in a highly collaborative, cross-functional team environment.
Project Management
Strong organizational skills and proven ability to manage multiple projects simultaneously, prioritize tasks, and meet aggressive deadlines.
Adaptability
Ability to thrive in a fast-paced, dynamic, and evolving scientific environment.
Benefits & Perks Offered
Our client understands that attracting and retaining top talent is crucial to their success. They are committed to providing a comprehensive and competitive benefits package designed to support the overall well-being and professional growth of their employees. As the Director of Analytical Chemistry, you can expect a suite of benefits that reflects the value placed on your expertise and contributions:
Competitive Compensation
An attractive base salary commensurate with experience and a robust annual performance-based bonus program.
Equity/Stock Options
Opportunities for stock options or other equity incentives, aligning your success with the company’s growth.
Comprehensive Health & Wellness
Generous medical, dental, and vision insurance plans for you and your family, with options for PPO and HMO coverage, often with low employee contributions.
Retirement Savings
A strong 401(k) retirement plan with a substantial company match, helping you plan for your financial future.
Generous Paid Time Off (PTO)
Ample vacation, sick leave, and paid holidays to ensure a healthy work-life balance and opportunities for rest and rejuvenation.
Life & Disability Insurance
Company-paid life insurance and short-term/long-term disability coverage for peace of mind.
Professional Development
Significant investment in your growth through opportunities for attending industry conferences, workshops, scientific symposiums, and continuing education programs. Tuition reimbursement may also be available.
Innovative Work Environment
Work within a cutting-edge scientific facility equipped with the latest technologies, fostering an environment of discovery and innovation.
Collaborative Culture
Be part of a highly collaborative, intellectually stimulating, and supportive team where your ideas are valued, and your contributions are recognized.
Employee Assistance Programs (EAP)
Confidential resources and support for personal and professional challenges, including counseling, financial advice, and legal consultation.
Wellness Programs
Initiatives focused on promoting physical and mental well-being, such as fitness challenges, ergonomic assessments, and health education.
Relocation Assistance
For exceptional candidates relocating to the Boston area, comprehensive relocation support may be provided.
Commuter Benefits
Pre-tax programs for public transportation and parking to ease your daily commute.
On-site Amenities
Depending on the facility, amenities such as on-site fitness centers, cafes, and recreational areas may be available.
Our client is dedicated to creating an environment where employees feel valued, supported, and empowered to do their best work. Join a company that cares about its people as much as it cares about its mission.
How to Apply
If you are a highly motivated and experienced Director of Analytical Chemistry ready to take on a challenging and rewarding leadership role, we encourage you to apply. This is a unique opportunity to contribute to groundbreaking science and significantly impact patient lives.
Please submit your resume/CV and a cover letter detailing your qualifications, leadership experience, and strategic vision for analytical chemistry in the biopharmaceutical industry. Highlight your most significant achievements in method development, validation, and team management.
To ensure your application receives prompt attention and to connect with our specialized recruitment team, please apply directly through JRG Partners. We look forward to reviewing your application and discussing how your expertise can contribute to our client’s success.
Connect with JRG Partners Life Sciences Recruitment Team Today!