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.

Main tasks and responsibilities

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.

The Candidate

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.

 Additional Tasks/responsibilities      

Presentation skill. Clear Communication skill (Verbal and written).

Job Demands

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.