Kaustubh Gawde works within Quotient Sciences’ Formulation team in Philadelphia, PA. He discusses his career with the company and what he enjoys most about his role.

Quotient Sciences is great place to learn and grow.

– Kaustubh Gawde

What does a Formulation Group Leader do at Quotient Sciences?  

My role as a Formulation Group Leader includes a variety of tasks. One side of this job is technical. I am a group leader as well as a SME for all the projects my team is working on. A group leader has to be responsible for all the troubleshooting that can occur during the execution of project. A group leader works with different departments such as Operations, QA, Material Management, Analytical Development, QC, PM, and BD to successfully execute each project. A group leader has to interact with a client whenever required if they have any formulation or development questions. As manager, I have to be responsible for all the actions of my team members. My team needs to be productive members of our organization, achieving personal growth, as well as growth in their overall career.

Describe a typical day in the Formulation Department.  

Morning starts with coffee and checking email and Teams messages. At the start of the day, we have a daily meeting to discuss manufacturing activities from the day before and provide an overview of activities for the current day. In a day, typically I have one internal meeting and a couple of project meetings to a give weekly updates on projects to clients. I make different kinds of documents and review already made by documents by my team. I also troubleshoot any problems that my department may have for various projects. The day ends with a meeting to summarize the day’s manufacturing activity.

How has your career progressed since joining us?  

I joined Quotient Sciences almost three years back. I started as a staff formulator. I worked on various projects over the last three years. With each project, I learned a lot about both manufacturing and formulation development. This is my first time working in a CDMO setting. I had never worked with a client facing organization prior. It was a brand new experience. For the past three years, I have worked on multiple projects at different stages of project lifecycles. I have worked on clinical phases 1, 2, 3, and late stage commercial projects. Skills required for each project were different and I had to adapt as needed to meet each project’s requirements. We also need different temperaments to deal with different clients. I learned how to work on multiple projects at the same time, perform multiple tasks such as manufacturing, documentation, client visits, and quality events. I became efficient at my job in staff formulation and gained a lot of technical skills/knowledge in a short period of time.

What experience did you have before you worked at Quotient Sciences?

I used in work in a generic drug product manufacturing company which made potent control substance products.  

Did you require any qualifications for the role you applied for?  

I had a Master’s degree in Pharmaceutical Sciences as well as three years of experience working with large scale manufacturing equipment. I was also part of various ANDA filling projects and had experience making product development reports.

What learning or qualifications have you gained in this role?

I transitioned from a scientist role to a group leader role last year. Both roles have different requirements. As a scientist, you only need to be good at your job. As a group leader, you have to be responsible for all the people in your group. As a group leader, I had to be up to date on the latest formulation and manufacturing techniques as well as perform my manager duties.

What do you enjoy most about your role?

As a group leader, I get to work on multiple projects that are assigned to my team. I work with BD to strategize the development work and scope of manufacturing. I also like working on different projects as it gives me new challenges and keeps me on my toes.

What aspects do you find most challenging?  

Time management at times becomes very difficult when we get multiple projects at same time. Also, some clients can be difficult to deal with as they are set in their own ways. Some clients have a difference of opinion with us which can be challenging to deal with at times.

What’s the team like?  

I report to the Senior Director of Formulation Development and Technical Services. Two staff formulators and two manufacturing scientists are in my team. My team is mix of experienced and inexperienced people. We train new hires with experienced team members.

What advice would you give to someone applying for a role in your team?  

Quotient Sciences is great place to learn and grow. Quotient Sciences gives you space to reach your career goals at your own pace. We have lot of new technologies and we are consistently looking to progress in the field.

What do you like most about working at Quotient Sciences?  

Quotient Sciences has lots of new technologies. I like my team. Quotient Sciences also promotes internal promotions. I like the core leadership team at my site. We have a visual representation of progress at Quotient Sciences. 

Yaribey Rodriguez works within Quotient Sciences’ Quality Assurance team in Miami, Fl. She discusses her career with the company and what she enjoys most about her role. 

What I like most about working at Quotient Sciences is to know that I am making a difference in the field of medical care. To know that I took part in the development of future treatments that can save lives, and that it was done with the outermost passion, dedication, and with the best team.

– Yaribey Rodriguez

What does a Senior Director GCP QA do at Quotient Sciences?

A Senior Director GCP QA is responsible for implementing, maintaining, and continuously improving Good Clinical Practice (GCP) compliance programs and the Quality Management Systems (QMS) to support the clinical trial activities at Quotient Sciences Miami.  This role provides QA oversight to assure clinical trial activities are conducted in compliance with applicable regulations, ICH GCP guidelines, and internal policies and procedures.  Other tasks include managing and conducting internal and supplier audits, hosting client audits, and serving as the point of contact and host for all regulatory inspections.  

Describe a typical day in the Quality Assurance Department.  

The Quality Department always has exciting and interesting days. Typically, it includes both required meetings and also daily firefighting activities to ensure the site is complaint and audit ready. These are accompanied by constant multitasking and rapidly shifting priorities to ensure the business continues to run smoothly. You would never be bored!

How has your career progressed since joining us?  

I joined Quotient Sciences under the tile of Director, GCP QA for the Miami site. Since then, I have developed to be a Senior Director, GCP QA.  

What experience did you have before you worked at Quotient Sciences?

Before Quotient Sciences, I was an Operational Excellence Leader with more than 10 years of experience and 40+ direct reports in the medical device industry under title 21 CFR Part 211 and 820 FDA/ISO 9001 environment, regulations, and compliance.

Did you require any qualifications for the role you applied for?  

Yes, for my role, necessary qualifications include knowledge of good clinical practices and ICH guidelines paired with FDA regulations that govern the clinical research field.

What learning or qualifications have you gained in this role?

I obtained the certifications of ISO 27001 auditor while in Quotient Sciences as well as have been able to attend several FDA seminars.

What do you enjoy most about your role?

The constant learning about clinical research is what I enjoy most about my role. Every study is different and brings new questions that spark my curiosity to know more. I also enjoy the people I work with. They make my job purpose absolutely amazing. My amazing team is always so supportive, effective, organized, and constantly in a state of development and collaboration.

What aspects do you find most challenging?

In my field, sometimes it is necessary to align to new regulations that require rapid modifications to our processes or procedures. This poses a challenge since it needs to be done while keeping the business running. But, this is a good challenge to have!

What’s the team like?  

I could not ask for a better team. Each of them shows an extreme dedication to the job, a genuine passion for what they do, and enjoyment for all of our accomplishments. I have the best team!

What advice would you give to someone applying for a role in your team?  

To have an open mind. To seek to understand others’ points of view, to always be hungry to learn more, and to aspire to be better each day.

What do you like most about working at Quotient Sciences?  

What I like most about working at Quotient Sciences is to know that I am making a difference in the field of medical care. To know that I took part in the development of future treatments that can save lives, and that it was done with the outermost passion, dedication, and with the best team. I love that Quotient Sciences is unique for its people and its vision! 

Michele Coraluzzi works within Quotient Sciences’ US People Team supporting both our Philly and Miami sites. She discusses her career with the company and what she enjoys most about her role.

I get a great sense of purpose from my role as I know I’m not just supporting people on my team but also supporting colleagues going through difficult times.

– Michele Coraluzzi

What does a HR Operations Specialist do at Quotient Sciences?  

As an HR Operations Specialist, I am responsible for maintaining and improving our HRIS (Dayforce), administering benefits, and overseeing leaves of absence. I also work to automate our People processes related to payroll, benefits, recruitment, onboarding, and compensation to improve the way the People Team works as well as make a more seamless experience for colleagues interacting with our HR systems.

Describe a typical day in the People Function.  

My day-to-day work is a mixture of administrative work and bigger picture projects. I assist employees with questions and paperwork for medical leaves of absence and changes to their benefits, work with our broker and benefit carriers, and work with our US People Team to help wherever I can. I also work on bigger projects related to Dayforce including data management, open enrollment, onboarding and new hire experience, and reporting.

How has your career progressed since joining us?  

Over the last two years, I’ve held multiple different roles within the People Function. I started working at Quotient Sciences in 2022 as an HR Intern where I wrote job descriptions for almost all Philadelphia roles. I then moved into a regional HR role where I was the Project Coordinator, implementing all modules of Dayforce (or what we at Quotient Sciences call People@Q) which allowed us to fully stand-up employment on our own. Since our implementation has been completed, I have now stepped into my current position as an HR Operations Specialist where I am working on continuous improvement, further automation and system maintenance, and benefits and leave administration. 

What experience did you have before you worked at Quotient Sciences?

Before joining Quotient Sciences, I was a college student! I was taking courses and had learned about HR in my classes. I had also worked in retail management throughout college where I learned some of the foundations of HR including hiring, performance management, training and onboarding, and employee relations, but Quotient Sciences taught me the real-life application of what it’s like to work in HR.

Did you require any qualifications for the role you applied for?  

After completing my HR internship with Quotient Sciences, I had officially graduated from Penn State University with my Bachelor’s in Business Management and Marketing with a minor in Psychology. My degree, along with my relationship with Quotient Sciences and the People Team, allowed me to feel prepared and competent in my role after college.  

What learning or qualifications have you gained in this role?

Quotient Sciences has taught me almost everything I know about HR! I’ve been fortunate to work with people who I consider mentors and have invested in my growth as an HR professional and in my career at Quotient Sciences. I would say because of the work I did with our system implementation; I was able to learn multiple aspects of HR on a fast-track. After my first year with Quotient Sciences, I looked back in amazement at how much I had learned in a short amount of time.  

What do you enjoy most about your role?

My favorite part of my job is the collaboration that I do with my team in both the US and the UK. I get to work with SMEs in both countries who are really talented at what they do. When we come together to build a new module in our HR system or improve one of our processes, it ends up being a huge accomplishment that changes the way we do things for the better across multiple departments.  

What aspects do you find most challenging?  

The most challenging part of my job has been learning multiple new skills at once. I have been learning about HR and all the US laws and regulations that surround it, and at the same time, I am learning about system configuration. We’ve had strict deadlines and significant challenges, and so my team and I have had to work through finding solutions and problem solving frequently. While I find it challenging, it’s also really rewarding as I’m kickstarting my career. I appreciate all the opportunities and challenges as it makes me a more well-rounded HR professional.  

What’s the team like?  

My immediate team as well as the teams I work with in cross-functional departments have all been really supportive and encouraging! Because we are a small team, everyone becomes an expert in what they do and we all know each other really well. We’re all really good at getting involved with each other’s projects, helping where we can, jumping on calls or meetings to answer questions, and also supporting each other personally, calling just to check in, and making genuine connections with each other.

What advice would you give to someone applying for a role in your team?  

When you’re considering a role working on the People Team, know that you are joining a great group of people who genuinely care for each other. We work in a small group where each one of us is responsible for different things, so your knowledge and contributions are extremely important and valued! You have to be willing to take responsibility for your portion of what makes our team successful while also providing support and guidance to the rest of the team and you will feel the same level of support returned to you!

What do you like most about working at Quotient Sciences?  

I enjoy collaborating with my team, but I also enjoy working for a greater good. I get a great sense of purpose from my role as I know I’m not just supporting people on my team but also supporting colleagues going through difficult times. Ultimately, I am supporting the work that we do at Quotient Sciences, benefiting the patients that we serve and lives that are being changed through our products. 

In this article by The Medicine Maker, Dr. Asma Patel, VP of Integrated Development Services at Quotient Sciences discusses how accelerating first-in-human (FiH) clinical trials is crucial in drug development, especially for orphan drugs treating rare diseases.

Asma points out how a simplified formulation approach, such as a drug-in-capsule method, can streamline the process.

Continue reading the full article on The Medicine Maker