JD275
Job Title: Director, Analytical and Process Development
Location: Bloomington, IN, on-site
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 requirement.
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, guide 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, gases, 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.