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Formulation Specialist, 3rd Shift

The primary responsibility of the Manufacturing Specialist in Formulation is to weigh/dispense, setup/operate equipment to produce the bulk drug product for sterile manufacturing. They will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. The ideal candidate should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and work effectively with internal partners, clients, and vendors. 
 
Key responsibilities:
  • Follow production and manufacturing procedures.
  • Perform duties in Grade C, D, and controlled non-classified cleanrooms.
  • Perform cleaning and sanitization, equipment preparation, and support aseptic filling duties as needed.
  • Operate formulation equipment including setup and post cleaning.
  • Accurately document data and complete batch records.
  • Execute validation/ engineering protocols, as needed.
  • Train others in various manufacturing tasks including, but not limited to: formulation/ dispensing, sanitization, component and equipment preparation.
  • Perform routine maintenance and troubleshooting of production equipment.
  • Support equipment optimization efforts and continuous improvement efforts.
  • Collaborate and communicate with cross-functional teams.
  • Work flexible hours to ensure production facility coverage.

Requirements:

  • 1+ year of GMP pharmaceutical experience focused on formulation and dispensing
  • 1+ year of experience with the installation, operation, cleaning, and maintenance of pharmaceutical equipment
  • High school diploma
  • Working knowledge of MS Office

Additional Preferences:

  • BS in biological sciences/ biotechnology
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
  • Ability to learn and operate a range of industry systems including and not limited to ERP and inventory management systems
 
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.  
 
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. 
 
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. 
 
By submitting your resume and details, you are declaring that the information is correct and accurate. 
 
 

Average salary estimate

$60000 / YEARLY (est.)
min
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$50000K
$70000K

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What You Should Know About Formulation Specialist, 3rd Shift, INCOG BioPharma Services

Are you ready to take on an exciting role as a Formulation Specialist on the 3rd Shift with INCOG BioPharma Services? This is not just any job; it's an opportunity to make a real impact in the pharmaceutical industry! As a Formulation Specialist, you'll be heavily involved in producing bulk drug products for sterile manufacturing. You'll be right in the action, weighing and dispensing materials, setting up equipment, and continuously improving our processes. We’re looking for someone with hands-on expertise who can step up as a mentor and guide to our manufacturing personnel, ensuring that production runs smoothly and on time. Your previous experience in GMP pharmaceuticals will shine as you operate equipment in various cleanroom environments. Plus, you'll be documenting vital data, maintaining records, and even training others in crucial tasks. Teamwork matters here! You'll work closely with cross-functional teams and communicate effectively with various partners, all while fostering a culture of quality and excellence. At INCOG BioPharma, you’ll be part of a unique and collaborative environment that values innovation and technical prowess. So, if you're passionate about creating systems that enhance quality and efficiency, join our dedicated team and help us accelerate the Route to Market for parenteral injectable drugs. We can’t wait to meet you!

Frequently Asked Questions (FAQs) for Formulation Specialist, 3rd Shift Role at INCOG BioPharma Services
What does a Formulation Specialist do at INCOG BioPharma?

A Formulation Specialist at INCOG BioPharma is responsible for producing bulk drug products through weighing and dispensing materials, operating formulation equipment, and ensuring quality control in sterile manufacturing settings. They lead improvements in processes and mentor manufacturing personnel.

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What qualifications are needed for the Formulation Specialist position at INCOG BioPharma?

The ideal candidate for the Formulation Specialist role at INCOG BioPharma should possess at least one year of GMP pharmaceutical experience, specifically in formulation and dispensing, along with a high school diploma. A degree in biological sciences or biotechnology is preferred.

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What skills are important for a Formulation Specialist at INCOG BioPharma?

Key skills for a Formulation Specialist include hands-on experience with pharmaceutical equipment, strong attention to detail, effective communication abilities, and the capacity for process improvement. Proficiency in MS Office and a knowledge of various industry systems is also beneficial.

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What kind of work environment can a Formulation Specialist expect at INCOG BioPharma?

At INCOG BioPharma, the work environment is collaborative and team-centered. Formulation Specialists work in cleanroom settings and must operate under strict adherence to GMP regulations, ensuring high standards of quality and efficiency.

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How does INCOG BioPharma support the growth of its Formulation Specialists?

INCOG BioPharma offers mentorship opportunities and encourages continuous learning and development for its Formulation Specialists. Employees can expect guidance in mastering their roles while also contributing ideas for process improvements.

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What are the hours like for a Formulation Specialist on the 3rd Shift at INCOG BioPharma?

As a Formulation Specialist on the 3rd Shift at INCOG BioPharma, you can expect flexible hours that allow you to contribute effectively to the production processes while ensuring coverage for the facility's needs.

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What is the culture like at INCOG BioPharma for a Formulation Specialist?

The culture at INCOG BioPharma is focused on technical excellence and a service-oriented mindset. Formulation Specialists collaborate closely with cross-functional teams and are encouraged to brainstorm better ways of doing business, all while ensuring quality outcomes.

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Common Interview Questions for Formulation Specialist, 3rd Shift
What experience do you have with GMP pharmaceutical processes as a Formulation Specialist?

It's important to highlight any specific roles where you've followed GMP guidelines, detailing the equipment you've handled, processes you've improved, and how your adherence to quality standards has positively impacted production.

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Can you describe a process improvement project you led as a Formulation Specialist?

In your answer, focus on the specific project, the challenges you faced, the actions you took to drive improvements, and the results you achieved. Use metrics where possible to quantify your success.

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How do you ensure the accuracy of your documentation as a Formulation Specialist?

Emphasize meticulous attention to detail, a structured approach to record-keeping, and the importance of documentation for maintaining compliance and traceability in pharmaceutical manufacturing.

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How do you approach training others in manufacturing tasks?

Discuss your training philosophy, highlighting the use of hands-on demonstrations, clear communication, and the importance of patience and encouragement to effectively teach manufacturing procedures.

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What techniques do you use for troubleshooting equipment issues in a formulation setting?

Provide examples of systematic approaches to troubleshooting, such as diagnosing the problem, consulting manuals, and collaborating with colleagues to devise solutions quickly and effectively.

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How do you prioritize tasks when working in a fast-paced environment like INCOG BioPharma?

Share your methods for effective prioritization, like assessing urgency and impact on production, utilizing checklists, and dynamic re-prioritization based on real-time production needs.

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Explain your experience with cleanroom protocols in pharmaceutical manufacturing.

Detail your familiarity with cleanroom practices, the importance of maintaining sterile conditions, and adherence to procedures that prevent contamination during the manufacturing process.

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What role does teamwork play in your work as a Formulation Specialist?

Highlight the significance of collaboration, describing how effective communication and team support lead to successful production outcomes and foster a positive work environment.

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What motivates you to pursue a career as a Formulation Specialist in the pharmaceutical industry?

Discuss your passion for contributing to healthcare, the satisfaction of solving complex challenges, and the desire to be part of a team that is committed to quality and innovation in drug manufacturing.

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How do you stay current with industry trends and best practices as a Formulation Specialist?

Mention your commitment to ongoing education, participation in relevant training, attending industry conferences, and actively engaging with professional networks to stay informed about new technologies and methodologies.

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INCOG BioPharma Services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, they offer customized packaging services t...

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Full-time, on-site
DATE POSTED
November 28, 2024

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