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    Director of Formulation Development - Chicago, United States - The Steely Group

    The Steely Group
    The Steely Group Chicago, United States

    4 weeks ago

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    Description
    Job Description

    Our client is seeking an experienced

    Director of Formulation Development

    to lead and manage a team developing innovative dosage forms and drug delivery systems. Reporting to the Sr.

    Director, Formulation Development, this role will provide strategic and technical leadership across formulation activities while also directing complex projects that are critical to advancing the company's product pipeline.

    As an expert in the areas of pre-formulation and formulation development studies, drug delivery technologies, and product development, this position will be responsible for providing guidance, oversight, and mentoring to a team of scientists.

    This role will anticipate potential developmental challenges and implement mitigation strategies to reduce program risk.


    Responsibilities:


    Lead and manage a team of scientists in the development and execution of complex formulation projects for injectable small molecules, peptides, and proteins using company's novel proprietary formulation platforms.

    Provide strategic direction and guidance to the formulation development team on all aspects of injectable small molecule, peptide, and protein formulations, including process development, characterization, scale-up, tech transfer and manufacturing support.

    Lead high throughput screening of excipients, selection of primary drug container closure systems, identification of degradation pathways, and development of stable formulations.

    Lead the development and implementation of novel formulation strategies for injectable products, including long-acting formulations, sustained release formulations, and targeted delivery systems.

    Demonstrate a thorough understanding of relevant technical/scientific literature, standard procedures, and pharmaceutical regulations relevant to the programs.
    Develop and implement innovative methods for characterization and stability testing of injectable biologics.
    Drive the development of robust and scalable manufacturing processes for injectable products.
    Identify and mitigate technical risks associated with formulation development and manufacturing. Anticipate manufacturability challenges associated with parenteral drug product development.
    Develop and manage project budgets and timelines, ensuring efficient and on-time completion of projects.
    Communicate effectively with cross-functional teams (e.g., R&D, Regulatory, Manufacturing) to ensure seamless product development.
    Provide guidance on quality aspects across regulatory filings related to specifications, acceptance criteria, and stability protocols.
    Cultivate partnerships by serving as lead point of contact with contract manufacturing organizations and external collaborators.
    Ensure compliance with all relevant regulatory requirements for injectable products, including ICH guidelines and FDA regulations.
    Contribute to the preparation and submission of regulatory documentation, including INDs, NDAs, and BLAs.
    Provide expert technical support during regulatory inspections and audits.
    Build a high performing team through mentoring, goal setting, and supporting the continuing education of junior staff.
    Contribute to the development of internal training programs and seminars related to formulation science and technology.
    Write and review study protocols and reports (both formal and informal) to support product development studies and regulatory filings.
    Stay current with the latest scientific literature and present findings at industry conferences and events.
    Identify and evaluate emerging technologies and trends in the field of injectable formulation development.
    Develop and implement strategic initiatives to improve the efficiency and effectiveness of the formulation development process.


    Qualifications:
    Ph.
    D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or related discipline and 10+ years in pharmaceutical development, with increasing management responsibility.
    Familiarity with regulatory requirements for pharmaceutical development.
    Passion for innovation and scientific discovery, developing junior staff, and advancing healthcare through novel medicines.
    Knowledge and proficiency using experimental design and statistical analysis software (e.g., JMP / MiniTab / GraphPad Prism).

    Competencies:

    Attention to Detail, Independent Judgement, Teamwork & Collaboration, Self-Starter, Adaptability, Professionalism, Written & Verbal Communication skills, Functional Leadership, Problem-Solving skills, Project Management skills.


    Working Conditions:
    Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
    Must be able to stand for extended periods of time. Must be able to lift 25 lbs. or more.

    Adequate vision (corrected or uncorrected) to read fine instruments such as instrument displays, etc., and perform visual inspection for defects.

    Position works with potentially hazardous chemicals and active pharmaceutical ingredients.
    Domestic and/or international travel up to 10% may be required.

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