Formulation/Filling Team Leader

Job Description
Why join Team Singota?


We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that's not just efficient, but also passionate, dedicated, and fun to work with.

Job title: Formulation/Filling Team Leader

Department: Manufacturing

Location: Bloomington, IN (Onsite)

Position Type: Full-time, non-exempt

Hours: 40 hr/wk, 1st shift

General Description:


While this position has a primary focus of Formulation and Aseptic Filling, all Manufacturing Team Leads actively participate in all the manufacturing operations for the company including:

1. Drug product formulation

2. Aseptic filling

3. Finished dose inspection/labeling/kitting/packaging

4. Sample and Dispense

General:

1. Lead and play major role in onboarding of new operators in area of assignment.

2. Provide back up to the Manufacturing Supervisors

3. Serve as SME (Subject Matter Expert) in area of assignment.

4. Own, draft, and revise area procedures.

5. Lead sub groups when projects require additional time outside of standard manufacturing shift hours, when necessary.

6. Must be able to work within the FDA regulated environment per 21CFR 210/211 requirements and those established by internal policy and standard operating procedures

7. Computer experience necessary. Proficiency with Microsoft Office (Outlook, Excel, Word).

8. Experience using equipment HMIs, as well as ERP or inventory systems desired

9. Attention to detail and good organization skills mandatory

10. Participate in and fully support process improvement initiatives

11. Ability to work in both collaborative and independent work situations and environments.

12. Must strictly adhere to all safety requirements, including wearing proper PPE (personal protection equipment) while performing operations, i.e. respirator, safety glasses, gloves, etc.

13. Job requires gowning to work in cleanroom environments

14. Perform cleaning/disinfecting/sanitization of cleanrooms

15. Assist in process investigations, writing of deviations, and implementation of CAPAs to continuously improve operations

16. Ability to stand for a minimum of 4 hours

17. Must have good documentation practices with clear, legible handwriting

18. Provide recommendations and implement solutions to resolve equipment and/or process problems in a timely manner

19. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures

20. General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business

21. Functions as the subject matter expert (knowledge, skills) in assigned departmental area (i.e. Formulation/Filling, Sampling and Dispensing, Finishing); in alignment with manager's directions

Formulation:

1. Precision weighing and measuring of buffers, excipients, API, etc.

2. Ability to use basic lab instruments, such as; pH meter, conductivity meter, pipets

3. Ability to use basic manufacturing equipment, such as; biosafety cabinets, mixers, pumps, filter testers

Aseptic filling:


1. Install machine change parts and load recipes on fill machine

2. Staging/loading of components and preparation of fill path

3. Perform cleaning and VPHP decontamination of isolators

4. Assist with environmental monitoring

Finishing (Inspection, Labeling, and Kitting):

1. Label and package filled drug product and/or pharmaceutical components per written specifications, SOP's, job aids and batch records

2. Inspect product and printed materials for defects

3. Responsible for reconciliation of all controlled printed materials and product

4. Setup and operation of labeling and packaging equipment and systems

5. Preparation and use of precision measuring instruments

Requirements

Skills and Physical Activity Requirements:


1. Excellent work ethic and attention to detail

2. Ability to communicate clearly, both written and verbally

3. Requires repetitive hand, wrist, arm motions

4. Hand eye coordination and manual dexterity with small components

5. Use of small tools and laboratory/production equipment

6. Clear, legible handwriting

7. Able to comprehend and execute complex written instructions


8. Must be able to lift, push, or pull up to 50 pounds

9. Positive attitude and good judgment

10. Good time management and organizational skills

Education and Work Experience Requirements:


1. High school diploma with minimum 5+ years industry experience (or similarly regulated industry)

or

2. Associates Degree in an Engineering or Science discipline(desired) with minimum 3+ year industry experience

or

3. Bachelor's degree in an Engineering or Science discipline(desired)

Singota Solutions is an Equal Opportunity Employer

Benefits

• Dental insurance - effective day one of employment
• Health insurance - effective day one of employment
• Vision insurance - effective day one of employment
• Health savings account
• Life & AD&D insurance
• Short & long term disability
• Paid time off & holidays
• Employee Assistance Program
• Tuition assistance
• 401(k) with company match

Singota Solutions is an Equal Opportunity Employer