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    Director, Analytical and Process Development - Bloomington, United States - Singota Solutions

    Singota Solutions
    Singota Solutions Bloomington, United States

    1 week ago

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    Description
    Job Description
    JD275

    Job Title: Director, Analytical and Process Development

    Location: Bloomington, IN (Onsite)

    Position: Full time, 40 hours/week, exempt

    Department: R&D and Operations

    Reports To: VP R&D and Ops

    General Role Description:

    The Director reports into the Vice President of R&D and Operations. It is a senior leadership role with responsibilities integrated across analytical, product and process development leading to products introduction into the manufacturing platform at Singota.

    It provides technical leadership to Analytical, Product/Process Development and Transfer activities tailored to Singota's clients' product development and clinical manufacturing requirements.

    The Director is responsible for establishing and implementing best practices for generation and integration of product and process knowledge generation across the groups accountable for analytical testing, formulation, process development, process characterization and introduction of products into fill/finish operations. In this role, he/she will engage in setting scientific standards for execution of R&D activities, integrating the ways of working to streamline execution, communication, and collaboration practices.

    The Director will have accountability in implementing actions and processes that will result in safe, high quality, efficient and cost effective outcomes. Will add to the company's culture to further develop highly motivated, functionally knowledgeable, and productive employees with processes driven to deliver customer satisfaction.

    As a member of Singota's leadership, the Director is engaged in establishing the company as a recognized industry leader in its niche through outstanding customer service, integrity, know-how, and on-time deliverables to clients.

    Main Responsibilities:

    1. Owns the technical knowledge flow and cross functional integration required to secure completion of activities assigned across Analytical Development QC, Product Development (Formulation) Process Development and its overall Transfer into Manufacturing.

    2. Leads, guides and delivers outcomes in close partnership with the managers and lead scientists in charge of knowledge and clinical materials generation.

    3. Owns the assessment of the scope of work associated with potential clients and ensures that project plans reflect the client's desired outcomes and Singota's efforts required to secure high quality and timely execution.

    4. Works integrated with client-facing groups (Business Development, Client Services) to best align Singota's services and capabilities with the client's needs and expectations. Directs Quality Control Functions including support for water systems, gasses, utilities, systems release, component inspection, container closure integrity testing, etc.

    5. Directs staff and manages resources (time, money, equipment, inventory)

    6. Oversees Microbiology Department, including sterility testing and environmental monitoring in collaboration with Quality.

    7. Oversees integration of control strategy elements including in-process and release testing for materials and products.

    8. Directs staff and activities associated with Formulation and Product Development activities executed at Lab scale prior to their internal transfer into production.

    9. Directs staff and activities associated with process development and associated characterization studies geared toward process transfer into production.

    10. Drives innovative improvements in R&D to reduce cost, lead times and improve throughput.

    11. Evaluates and deploys processes and capabilities needed to deliver first in class execution of current and future business demands.

    12. Implements, monitors, and reports performance metrics.

    13. In coordination with Business Development, Client Services and Planning departments, participates in capacity and forecast analysis.

    14. Represents Development, QC, Process Dev. and Tech Ops in cross functional meetings. Sponsors integration of quality and innovative solutions culture. Leads continual improvement efforts.

    15. Ensure compliance to applicable laws and contractual obligations and deployment of good business practices in support of them.

    16. Utilize company resources effectively and coach others to do the same.

    Characteristics required include:

    1. Positive attitude and good judgment, a person people seek out for advice.

    2. Excellent communication skills - oral, written, listening, inclusive of others' ideas.

    3. Trustworthiness, personal integrity; able to maintain a high degree of confidentiality.

    4. Effective time management and organizational skills

    5. Connected and involved in life sciences industry initiatives and community.

    6. Personal accountability, learning agility, collaboration, personal touch and stewardship.

    Requirements

    Work Experience & Educational Requirements:

    1. Minimum of 15 years work experience with 10 years in pharma and/or life sciences experience, preferably in sterile products

    2. Minimum of 5 years work experience in pharmaceutical R&D with people management responsibilities

    3. Minimum of BS in applicable technical field (i.e., scientific disciplines, engineering, etc.)

    4. Experience with Six Sigma, Lean manufacturing, Value Stream mapping experience a plus

    5. Experience working in a startup that grew rapidly is a plus, or other entrepreneurial experience.

    Benefits
    • 401(k)
    • 401(k) matching
    • Dental insurance
    • Health insurance
    • Health savings account
    • Life insurance
    • Paid time off
    • Tuition reimbursement
    • Vision insurance
    Singota Solutions is an Equal Opportunity Employer

    Singota is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a disability, please send an e-mail to or call to let us know the nature of your request.

    The voluntary self-identification forms used by Singota Solutions only to collect and maintain records required of employers doing business with the federal government. YOU DO NOT HAVE TO ANSWER THESE QUESTIONS TO BE CONSIDERED FOR EMPLOYMENT WITH Singota Solutions. If you do choose to answer these questions, any information supplied by you on this voluntary self-identification form will not affect your employment opportunities with Singota Solutions, which is an equal employment opportunity employer.

    If we need additional information or want to schedule an interview, we will contact you. If your qualifications do not match our current needs, we will keep your resume and/or application on file for one year.

    Thank you for visiting EMPLOYMENT OPPORTUNITIES at Singota Solutions
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