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Director, Analytical Development
Director, Analytical DevelopmentEyePoint • Watertown, MA, US
Director, Analytical Development

Director, Analytical Development

EyePoint • Watertown, MA, US
1 day ago
Job type
  • Full-time
Job description

Eyepoint Job Opportunity

Be seen and heard at EyePoint, where leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for :

  • Preventing blindness through vision-saving medications
  • Delivering best-in-class proprietary pharmaceutical technologies
  • Transforming ocular drug delivery

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

Based in Watertown, MA and reporting to the Sr. Director of Analytical Development, this position is responsible for the implementation of evolving scientific technologies to advance the development of ocular drug products towards commercialization.

The successful candidate needs to have demonstrated experience in various physicochemical methods (chromatographic, spectroscopic, thermal and rheological analysis), chemical assays, functional assays, impurity and residual testing, stability and degradation studies to support the overall product release, process control, product characterization, process improvements, data analysis, comparability assessments and regulatory submissions.

The position holder will work within a collaborative, cross-functional pharmaceutical sciences team, contributing to program management strategies and applying their expertise to ensure the delivery of high-quality innovative therapies to patients. Supervisory experience is a plus.

Responsibilities

Primary responsibilities include, but are not limited to, the following :

  • Evaluate and implement new analytical technologies and contribute to strategic planning for analytical development and control strategies for small molecules.
  • Collaborate in development and phase appropriate qualification or validation of analytical methods for release, stability, comparability and in-process testing.
  • Cooperatively work with CMC teams and personnel from other departments such as Formulation Development, Quality Control and Quality Assurance, Regulatory Affairs, and Project Management.
  • Ensure that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards and guidelines. Maintain an understanding of current laws & regulations applicable to the pharmaceutical / biotechnology industry.
  • Guide method transfer and troubleshooting at contract testing labs and CDMOs.
  • Perform data review, statistical analysis and method optimization for complex physicochemical methods.
  • Lead characterization studies for structural elucidation and fate and purge studies to support regulatory submissions. Lead technical assessments and risk analyses to inform program strategies.
  • Develop phase appropriate control and release strategies, specifications to support GMP manufacturing of drug substance and drug product.
  • Identify, plan and complete necessary product and container compatibility, leachables and extractables studies necessary for the stage of the regulatory submission.

    • Stay abreast of emerging technologies, methodologies, and industry trends and contribute to the continuous improvement of laboratory workflows and capabilities.

    Qualifications

    Primary skills and knowledge required include, but are not limited to the following :

  • Proven expertise in design, development, qualification, validation, and lifecycle management of analytical methods for drug substances and drug products for small molecules.
  • Solid knowledge of late-stage analytical development for drug substance and drug product development (Phase 3 to commercialization).
  • Proficiency with analytical instrumentation such as HPLC, UPLC, LC-MS, GC, GPC and advanced technical skills in solid state characterization of drug substance / intermediates / final product functionality (e.g. Rheology, XRPD, TGA, DSC, DVS, BET, IR, Raman, microscopy, particle size analysis, etc)
  • Experience with large molecule characterization techniques is a plus.
  • In-depth knowledge of current regulatory guidance including ICH, FDA, EMA / JP and experience in managing IND / IMPD and NDA filings.
  • Experience in managing external contractors and contract development and manufacturing organizations (CROs, CDMOs) for analytical activities, including method development and validation.
  • Excellent time management, project management, and strategic thinking.
  • Flexible, adaptable and collaborative style with a willingness to take on new challenges and positively respond to changes.
  • Excellent interpersonal, technical writing, and oral communication skills.
  • Able to identify key performance metrics, generate actionable reports and communicate complex information clearly to internal stakeholders.
  • A team player who is able to collaborate effectively with a broad range of internal functions.
  • Possesses high integrity and exceptional work ethic.
  • Ability to travel domestically to achieve goals, when required.
  • Supervisory experience is a plus.

    • Level of Education Required : PhD in Analytical Chemistry or related scientific field with 15+ years industry experience.

    Number of Years of Experience in the Function and in the Industry : At least 12 years of relevant experience in the pharmaceutical industry

    With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

    The collective power of our values influences everything we do, and everything we do for you.

    Transformational Innovation

    We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

    Unwavering Integrity

    We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

    Compassionate Excellence

    We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

    Inclusive Collaboration

    We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

    EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

    EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.

    The target salary range for this position is listed below.

    Min

    USD $197,760.00 / Yr.

    Max

    USD $249,947.00 / Yr.

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