What are the responsibilities and job description for the Manager, GMP Manufacturing position at Quotient Sciences?
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.
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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
The Role
Quotient Sciences are recruiting for a Manager, GMP Manufacturing for our Chelsea Parkway site in Boothwyn, Philadelphia.
Reporting to the Operation Head, the Manager will be responsible for leading assigned Product(s) intended for Clinical or Commercial manufacturing through Technology Transfer, Process Validation, and Clinical, and Commercial manufacturing in a timely and compliant manner.
The Core functions of the Operation Manager will include the following
The job involves the following:
When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
The Role
Quotient Sciences are recruiting for a Manager, GMP Manufacturing for our Chelsea Parkway site in Boothwyn, Philadelphia.
Reporting to the Operation Head, the Manager will be responsible for leading assigned Product(s) intended for Clinical or Commercial manufacturing through Technology Transfer, Process Validation, and Clinical, and Commercial manufacturing in a timely and compliant manner.
The Core functions of the Operation Manager will include the following
- Knowledge of Scale-up and Optimization of the manufacturing process before Registration Batches, leading to Commercial launch.
- Working closely with the technical service group and scientist who designed the manufacturing process, with a focus on Commercial manufacturability, we ensure a smooth technology transfer of the process from phase III clinical to Registration to Commercial launch.
- Work closely with other cross-functional groups such as Supply Chain, QA, QC, and Project Management to ensure timely project delivery.
- Leading the Product portfolio (Approved commercial product) with the product management team and attend client meetings, and providing regular updates.
- Technical writing includes (but is not limited to) protocols, reports, risk assessments, memorandum, investigation reports, change control, MBR, and other documentation.
- Comply & adhere to CGMP & GDP guidelines and regulations as required of this role.
- Responsible for ensuring compliance through Compliance Wire, KnowBe4, Veeva, and other training medium provided by Quotient, and follow procedures that govern the work performed in this role.
- Leading the manufacturing area Audit tour along with cross functional team and handling the audit response in timely manner.
- Manage and direct the work of the operation group and ensure timely deliverables.
- 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.
- Develops and implements training programs for the department personnel.
- Perform and/or manage daily manufacturing operation / task with operation team members.
- Collaborate with Formulators, Clients, technical service and cross-functional team and ensure that daily operation task completed as per timeline.
- Leading the Product portfolio (Approved commercial product) with the product management team and attend client meetings and provide regular update.
- Wite the GMP documents such as (but not limited to) protocols, reports, risk assessments, memorandum, investigations report, Change control, MBR and other documentation.
- Comply & adhere to CGMP & GDP guidelines and regulations as required of this role.
- Leading the manufacturing area Audit tour along with cross functional team and handling the audit response in timely manner.
- Ensure operational delivery is consistent with our Quality Compliance and EHS requirements.
- Create a culture in operations, backed by systems, processes and governance that ensures a balanced scorecard approach to operational delivery with EHS, Quality Compliance and Operational Efficiency and right first time prominent.
- Build and maintain strong relationships with customers by developing and implementing integrated operational delivery offerings to ensure Quotient remains competitive in commercial landscape.
- Create a culture of customer service excellence ensuring the customer offering is always of the highest standard.
- Provide leadership, coaching and mentoring of the teams to ensure appropriate development of each team, and that team members are trained appropriately to deliver the tasks to which they are assigned Manage the work of Junior Process Engineers.
- Minimum bachelor’s degree in pharmacy, Chemical Engineering, Sciences or its equivalent and a minimum of 5 years’ experience in a GMP manufacturing environment of Oral Solid Dosage forms in a CDMO, Generics, Nutraceuticals or Brand organization.
- Experience with Oral solid dosage manufacturing including Scale-up principles, Process Optimization, statistical controls, and Manufacturing Investigations.
- Minimum 2 years of Supervisory experience or management of operation team.
- Manages COM projects to deliver results on time and on budget.
- Focused on Meeting Customer Needs
- High degree of professionalism, ethics, and integrity
- Incumbent must be able to be accountable for own actions and complies with the laws and company policies.
- Presentation skill.
- Clear Communication skill (Verbal and written).
The job involves the following:
- Very high concentration of work at times and at regular intervals
- Strict and tight agreed-upon deadlines
- Having to juggle on various tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Needing to respond to client demands
- Ability to take appropriate actions in cases of emergency, critical or hazardous situations.
When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
