Director - Analytical Chemistry​/Scientific & Business Operations

The Director of Scientific & Business Operations position and will be responsible for helping to supervise and mentor a team of Analytical Chemists in several aspects of department operations, including reporting, method validation/qualification, investigating deviations and unexpected results within R&D and GLP/cGMP environment. This person will serve as a liaison between our internal team and our pharmaceutical clients.

We are seeking an experienced technical/scientific chemistry leader who has in-depth knowledge and a specific understanding of drug development for small molecules and biologics. This individual would provide strategic direction to the project teams and support the company’s Analytical Chemistry Business Unit and Management. We are looking for a strong, entrepreneurial thinker and problem solver with an outstanding track record of building and leading scientific teams.

You will be responsible for activities in support of our expanding pipeline of Client projects. This position will report directly to the CEO.

• Consults with clients on scientific needs, responds to RFPs, and establishes the appropriate scope of work in collaboration with the Business Development team
• Works in collaboration with the Business Development team to outline the scope of work, provide budgetary input, set project timelines, and anticipate technical challenges for each project
• Participates in client meetings and preliminary discussions regarding client needs, provide technical knowledge to help outline project requirements and answer technical questions
• Establishes the design and manages the conduct of studies in compliance with the protocol/amendments/planned changes, SOPs, and all applicable regulatory requirements, i.e., GLP, GCP, ICH, etc.
• Serves as a single point of contact for project directors and scientific team after project initiation
• Organizes and communicates complex data sets clearly and concisely to key stakeholders from diverse backgrounds
• Reviews and approves reports, or reporting of results, within study timelines, ensures any deviations/exception events are reflected as appropriate, and assures that all analysis conducted is reported and is accurate
• Collaborating with the Chief Scientific Officer to support the growth and development of the department. Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities
• Work interactively and cooperatively with all functions of the company and with senior staff to help achieve the company’s vision
• Regular attendance and punctuality for all meetings and daily activities
• May supervise team members within the work group
• These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.
• These job requirements are not intended to be construed as an exhaustive list of all duties and skills required of the candidate.

• Ph.D. or Master’s degree in chemistry is preferred, or an equivalent combination of education and experience
• 5-7 years of pharmaceutical industry experience
• 3 years of progressive management responsibility or equivalent work experience
• Strong Analytical background, as well as a knowledge of cGMPs, ICH, relevant FDA guidelines, and experience in writing relevant regulatory submissions
• Experience in IND-enabling study design and management is preferred
• The candidate should be a strong team player with excellent oral and written communication skills and with a demonstrated ability to interpret data, troubleshoot, and suggest next steps
• Refine and enforce R&D and cGMP/GLP policies with emphasis on compliance with the company’s Quality Management System (QMS) and external regulatory standards, including ISO-17025 and FDA regulations
• Appropriate technical experience in relevant laboratory techniques within a regulated environment
• The position is onsite full-time, Monday - Friday, 9:00 am - 5:00 pm
• Proficiency in hands-on analytical work while managing internal and external activities
• Exhibit strong technical skills and the ability to critically evaluate raw data and results without supervision
• Must be skilled in the operation of chromatographic data acquisition and processing software packages such as Agilent Mass Hunter, Thermo Scientific Chromeleon Chromatography Data System (CDS) software, Bruker Top Spin, Waters Empower Chrom Scope, and other software tools for data reduction and presentation
• Experience with deposition, intellectual property, and litigation-related projects a plus