Senior Scientist, Parenteral Operations MST Job Listing at Kelly Services in Indianapolis, IN (Job ID US3526197_BH9696643)

Description

Title: Senior Scientist, Parenteral Operations MST
Location: Bloomington, IN (Onsite)
Salary: $105-115,000 + Benefits 
1st shift

 

General Description:

The Senior Scientist, Parenteral Operations MST serves as a group leader and technical expert responsible for transfer activities leading to a robust and reliable manufacturing of selected parenteral product presentations using our manufacturing technology platform. Together with his/her team, will advance and deploy manufacturing sciences expertise for end-to-end parenteral operations for formulation, filling, and inspection lines. Serves as technical parenteral operations resource for internal parties. This role's objectives include analyzing equipment/process data, monitoring production metrics, authoring and executing protocols, and serving as a technical asset for process improvement and root cause investigations. This role is expected to interface regularly with the manufacturing operations and engineering teams in support of day-to-day operations.

 

Key Functions: 

• Ensure phase appropriate transfer and scale up/scale down for clinical material from our clients to internal manufacturing platforms
• Assist in leading and ensures the success of new process and product presentations into manufacturing.
• Ensures that technology transfer documentation is completed timely and enables flawless execution.
• Drives the implementation of continual improvements documents associated with process transfer to manufacturing. Coordinates timely “Lessons Learned” reflecting and leveraging acquired outcomes to future activities
• Prepare and Review, as required, relevant technical documents, such as: Batch Records, Change
• Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFMEAs, etc.
• Performs assessments of incoming product and process knowledge available in scope of new technology transfers
• Provide input and requirements to drug product development in relation to materials in direct product contact (i.e single use materials, primary container closure systems)
• Support investigations, CAPAs, change controls according to assigned responsibilities and perform critical raw data review for key document.
• Assist in assess new technologies/applications: feasibility, business case, conceptual design, installation and implementation.
• Evaluates the required resources and timing necessary to execute clients' studies. Designs process characterization studies and leads the team to complete execution of agreed upon work and milestones.
• Participates to knowledge generation and integration across R&D and Ops activities. Shares acquired knowledge internally and during client meetings
• Establish metrics on tasks, performance, and status of deliverables for Technical Operations activities. Performs data analytics to convert results into knowledge, provide useful and easy to use structured information than transferred into clients reports.
• Functions as department's Parenteral Manufacturing Science subject matter expert. Leads and grows a team focused on support to manufacturing and prepares instructions and documents required for product manufacturing. Mentor scientists, MS&T and process engineers
• Performs standard supervisory duties assigned by Human Resources, including but not limited to mentoring employees,
• Supports Business Development and Client Services on new and repeat business.
• Assist in providing ongoing support for building executable protocols, documenting with accuracy, execution and summarizing study outcomes. Shares results and outcomes internally and to clients.

Characteristics Required:

• Demonstrated proficiency and experience with pharmaceutical sterile process development and fill/finish operations, in particular isolators and robotic filling technologies
• Experience with clinical development and manufacturing
• Motivated with the ability to work independently and manage direct reports with demonstrated problem-solving skills is required.
• Strong experimental and technical writing and documentation skills, experiments in pharmaceutical regulated environment following (i.e 21CFR 211 )
• Strong interest and commitment to exceptional customer service and teamwork.
• Excellent time management, organization skills, and ability to manage multiple priorities
• Excellent communication and presentation skills – ability to communicate effectively across various audience

 

Work Experience & Educational Requirements:

• PhD in Pharmaceutical, Biochemical, Chemical, Life Sciences, Engineering or a related field with 3+ years of experience.
• Master's degree with 5+ years of experience
• Bachelor's degree with 8+ years of experience is required.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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