The Director, Formulation and Analytical Development will have the responsibility of defining strategic approach and executing empirical studies to develop novel formulations and perform analytical characterization for two novel platforms. The position will report into the VP, Process Development and Manufacturing Sciences.
- Define and develop formulation and characterization strategies for potential consumer and pharmaceutical pipelines;
- Build a high performing formulation and analytical development team to achieve aggressive goals and timelines;
- Manage employees and hands-on operations of the company's formulation and analytical function, both internal and outsourced;
- Play an active role in negotiations and oversight of development and manufacturing partners and critical raw material suppliers
- Ensure that, as the company grows, capabilities meet or exceed all industry and customer requirements for cost, quality and responsiveness;
- Develop and manage budget and budget execution;
- Direct all formulation development and associated analytical characterization; some hands on work is expected
- Work closely with R&D group to develop and deliver novel controlled release oral formulations, assays, and analytics;
- Develop a deep understanding of relationships between the structure and function of the novel modalities and associated formulations
- Serve as primary author for relevant CMC sections of regulatory submissions
- Cross-functionally identify, correct, investigate and resolve all quality issues in a timely and efficient manner;
- Develop production and resource plans that meet production goals in terms of safety, quality, output and cost;
- Select, develop, and evaluate personnel to ensure the efficient operation of the function.
- 10+ years experience in a Biologics or small molecule manufacturing management role at a life sciences GMP/FDA regulated company (from the Biotech, Pharmaceutical sectors).
- PhD in Scientific and/or Engineering discipline, or demonstrated success and 12 years of experience at managerial level managing formulation and analytical functions
- A proven track record in developing, characterizing and scaling up formulations for oral and systemic administration from pre-clinical through late-stage development.
- Extensive hands-on experience in the development and clinical manufacturing environment towards the development of novel formulations.
- Experience in developing immediate, modified and controlled release formulations and dosage forms.
- Prior experience in developing lipid formulations a plus
- Familiarity with evaluating formulation compatibility, optimization and characterization.
- Proficiency in analytical techniques like HPLC, TLC, DLS, UV-Vis and Fluorescence spectrophotometry, is preferred.
- Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE) required.
- Familiarity with a contract manufacturing environment with an in-depth knowledge of biologics drug product unit operations, impact of process parameters, in-process characterization techniques, process development, and principles of cGMP is a plus.
- Experience as primary author of relevant sections of INDs and other regulatory documents.
- Established and demonstrated experience in using a wide variety of formulation concepts across multiple development programs to deliver to a project’s Target Product Profile; experience in formulation or process technologies to employ enabling formulation technologies or unique delivery systems is desirable.
- Prior experience in technical transfers, qualification, validation, trouble shooting, Regulatory inspections, process scale-up, and commercial operations support.
- Experience with aseptic processing, sterile manufacturing a plus but not required.
- Hands-on, can-do individual with a collaborative personal style and the ability to work well in a fast-moving team/collaborative environment.
- Ability to effectively work independently and in a team environmentSignificant GMP/cGMP experience is required.
- Evidence of creativity in addressing challenging manufacturing approaches is required.
Senda Biosciences is an Equal Opportunity Employer. Senda does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.