Staff Formulator / Sr. Staff Formulator (Formulation Scientist)
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- Develop stable and bioavailable pharmaceutical dosage forms. Develop and optimize manufacturing processes and manufacture clinical supplies
- Provide direction and oversight for product and process development/scale up/transfer activities at internal projects and between sites
- Provide scientific knowledge in study design, scope of work and timeline
- Build strong internal and external relationship with key stakeholders to facilitate project delivery and meet projects timeline
- To comply & adhere to Good Manufacturing Practice (GMP) standards
Main tasks and responsibilities will include:
- Plan, Perform and Present various projects in oral solid dosage forms but not limited to, in a fast-paced contract manufacturing environment
- Develop a wide array of formulations including immediate and modified release for Phase I – III
- Scale up formulation and processes from lab to pilot scale to commercial manufacturing
- Manage technical Transfer of commercial scale process for Product intended for U.S., Europe, and Japan
- Scale up and mfg. Registration/submission batches for ANDA and NDA products
- Document, Manufacture and Package clinical supplies (Phase I – III) under cGMP environment
- Prepare and execute process validation batch records, reports, and associated documents
- Present data and propose new plans for internal teams and to the clients. Extensive interaction with Customer (clients) on a day-to-day basis, to provide deliverables with aggressive project timelines
- Author product specifications, process validation protocols, batch records, and development reports
- Coordinate QA, Analytical and Development activities to assure successful product delivery
- Other activities as directed by supervisor, or as described in the QS Pharma Employee Manual
- Train and direct manufacturing technicians and new employees
- Cooperative, independent, capable of critical and strategic thinking and multi-tasking.
Additional responsibilities include:
- Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures
- Working overtime as needed
- Adapt and Adept to changes and deliverables and communicate with cross functional teams and clients
- Learning and contributing new skills, procedures, and processes as part of continuous improvement or operational excellence
- M.S. Degree in Chemical Engineering/Pharmacy/Pharmaceutical Sciences or other related field plus 2-4 years’ experience in the pharmaceutical development and mfg. or B.S. degree in Chemical Engineering/Pharmacy/Pharmaceutical Sciences or other related field plus 5-7 years’ experience in the pharmaceutical industry
- In depth knowledge in theory and technical aspects solid oral development and production process
- Technical hands-on process experience with immediate release, modified release solid oral dosage forms and highly potent API/formulation
- Familiarity with a variety of laboratory equipment and manufacturing equipment’s and mfg. process
- Experienced in guiding and drafting documents such as safety procedures, operating and maintenance instructions, and standard operating procedure (SOP) manuals
- Experience with Quality by Design (QbD) and design of experiment (DoE) studies to assess robustness and optimization of drug product formulation and manufacturing process
- Experience is cGMP, GDP guidelines and with regulatory agency such as FDA/EMA/ICH guidelines and CMC sections for IND and NDA submission
- Strong verbal, written communication, and presentation skills
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.