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Director, Formulations Development

Director, Formulations Development

Ovid TherapeuticsNew York, NY, US
2 days ago
Job type
  • Full-time
  • Quick Apply
Job description

Welcome!  Ovid Therapeutics is a biopharmaceutical company developing medicines designed to conquer seizures with courageous science.

We exist to serve and meaningfully improve the lives of people affected by epilepsies and brain disorders with seizure symptoms.

It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families.

With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives.

Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share.

The Role On Our Team We are seeking an experienced formulation development and process development scientist in the New York City, Philadelphia, or Boston area for a new and uniquely broad role spanning from formulation discovery to pharmaceutical development, to deliver multiple drug product options for CMC manufacture.     Working across functional groups, the Director will be responsible for providing leadership and decisions on small molecule drug products from drug discovery to clinical studies.  As the lab functions are completely outsourced, strong communication and interpersonal skills are needed to direct work done in CROs and CDMOs in remote locations often in different time zones.

Broad technical expertise and leadership in formulations, process development, and CMC will be critical to the success of the role.    Reporting to the CSO, this is a highly visible and team-facing role.

The role is a hybrid of office visits in NYC a few times a month, working from home, and meeting with other colleagues in local workshare locations.

Job Responsibilities :

  • Serve as a senior member of the R&D Team responsible for developing and establishing small molecule strategies Provide leadership and direction for the area of formulations, process development, and clinical CMC for small molecule formulations including oral solid dosage forms and sterile injectables Provide leadership and hands-on technical, operational, and strategic guidance on a wide range of activities across all development stages from lead optimization of pre-clinical drug candidates, pre-formulation, formulation development, process scale-up, technology transfer, and process validation of clinical drug candidates Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements and provide technical support to internal and external cGMP manufacturing operations Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding to support product robustness targets Liaison with internal and external stakeholders to ensure there is accurate levels of finished goods material availability per demand management requirements to reduce obsolescence, minimize expired items and maximize inventory turns Provide guidance and strategic directions through interactions with each project team.
  • Work across functional groups in Research, Regulatory and external partners identifying issues that may delay timelines, providing solutions to difficult technical / functional issues associated with specific projects, as well as support the resolution of issues that arise Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections Your Expertise - minimum requirements Minimum of BS in a related field with 10+ years of relevant process development, formulations, and CMC of pharmaceutical products and supporting CMC clinical programs Small molecule experience in drug discovery teams Demonstrated experience for leading early-stage pharmaceutical development functions Your Background and Experience - preferred qualifications MS with 8+ years or PhD with 6+ years of relevant experience.
  • Advanced degree in chemical engineering or chemistry or pharmaceutical development Experiences designing and optimizing drug formulations, conducting stability studies, analyzing data, preparing technical reports for regulatory submissions, and collaborating with cross-functional teams Have experience in the production of small molecules (API and drug product) from planning through procurement; technical transfers, qualification, validation, trouble shooting, NDA’s, FDA inspections, process scale-up, and commercial operations support Experience with managing contract manufacturing organizations and be familiar with supply chain architectures including vendor selection, qualification, and contracting Have outstanding written and verbal communication, including listening, presentation, and conveying technical information for a broad audience.
  • Bring a history of great collaboration and teamwork with the ability to motivate and influence others; have a reputation for successful partnering with internal and external stakeholders Have the ability and the drive to succeed in a small biotech organization.
  • Interest to grow in the function to advance new technologies in new therapies.
  • Must be self-motivated, proactive, work well under pressure and deadlines, and thrive in a small “all hands-on deck” environment Solution-oriented thinker who possesses a “can do” attitude with a strong sense of urgency Have strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best path forward in the face of competing points of view Create a balance of analytical and methodical problem solving with creative and flexible solutions We operates in a hybrid-work model.

Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs.

  • The base salary range for this position is $220,000 - $270,000. The actual salary offered within the range is dependent on a variety of factors including, but not limited to , relevant experience, qualifications, skills, level offered, and performance expectations.  Powered by JazzHR
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    Director Formulation • New York, NY, US

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