Senior Group Leader
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 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.
- Provide direction and oversight for product and process development/scale up/transfer activities at internal projects and between sites.
- Provide leadership to ensure scientific knowledge in study design, scope of work and timeline.
- Provide supervision to a portion of the Formulation Development Group and Clinical Supplies Manufacture, Packaging and Labeling at Quotient Sciences, Philadelphia facilities
- Build strong internal and external relationship with key stakeholders to facilitate project delivery and meet projects timeline.
- Ensure compliance and safety practices followed by the team during daily activities.
Main tasks and responsibilities will include:
- Supervise or lead team of 3-5 technical personnel, including Senior Staff Formulator, Staff Formulators and Associate formulators.
- Participate in discussions with existing & potential clients to ensure effective dialogue leading to a project award at Quotient Sciences.
- Manage detailed project plans with lead formulator and project management team to ensure clarity and attainment of milestones and timelines; develop mitigation plans as needed to achieve project deliverables.
- Provide Guidance to the formulator to conduct pre-formulation, formulation, manufacturing process development/optimization for various solid dosage formulation and process development work.
- Directs and manages some projects to meet the agreed upon timelines and works closely with internal/external groups to meet all Client and Quotient Sciences technical milestones.
- Demonstrate scientific, technical proficiency in the area of Formulation Development, Scale up/ Tech. Transfer, Cleaning Verification and Clinical Supplies.
- Identify issues and facilitate problem solving, contingency planning, and decision making.
- Responsible for understanding and developing procedures for administrative, operational and equipment SOPs.
- Lead and ensure any quality investigations are completed in a timely manner to minimize interruption to supplies.
- Ensure timely review and approval of development and manufacturing documents such as Development protocol, development report, manufacturing/ packaging batch record and DOE protocol.
- Develops and monitors performance plans and requirements for direct reports. Mentor direct reports to achieve and improve their performance for company and personal career growth.
- Support Technical transfer from internal project to the process validation group and commercial group.
- 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.
- Attend client meeting regularly and update the client on time.
- Conduct routine checks to ensure proper GMP, and GDP compliance
- Prepare the team to support audits
- BS in Pharmaceutical Sciences, Chemistry, engineering, Material Sciences or related scientific discipline with 6+ years of pharmaceutical industry experience in small molecule, oral drug product, or liquid and semisolid development and clinical manufacturing.
- MS/Phd in Pharmaceutical Sciences, Chemistry, engineering, Material Sciences or related scientific discipline with 3+ years of pharmaceutical industry experience in small molecule, oral drug product.
- Previous supervisory experience in leading the teams is essential.
- Experience and successful track record in development and commercialization of oral solid dosage form.
- Excellent verbal and written communication skills required.
- Good inter-personal skill to work with QA, QC, regulatory, internal, and external customers.
- Cooperative, independent, capable of critical and strategic thinking and multi-tasking.
- 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 with regulatory agency such as FDA/EMA/ICH guideline and cGMP, clinical phase development and global requirement for IND and NDA submission.
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 email@example.com.