Devens, MA, United States
**MEMBERS ONLY**SIGN UP NOW***. (‘JM’) is a global leader in science that enables a cleaner and healthier world. With over 200 years of sustained commitment to innovation and technological breakthroughs, we improve the function, performance and safety of our customers’ products. Our science has a global impact in areas such as low emission transport, pharmaceuticals, chemical processing and making the most efficient use of the planet’s natural resources. Today more than 14,000 **MEMBERS ONLY**SIGN UP NOW***. professionals collaborate with our network of customers and partners to make a real difference to the world around us.
The Lead is responsible for managing the QC team workload and ensuring staff give timely support for manufacturing and GMP compliance. Provides guidance on procedures to ensure continuous improvement in customer satisfaction, related regulatory compliance, and operational safety and efficiency of the group. Oversees QC projects ensuring timely completion with quality, and within the budget. Provides leadership to the group through effective communication, training and ensures staff acts in accordance with **MEMBERS ONLY**SIGN UP NOW***. policies and practices with respect to GMP, safety, and other related regulatory requirements.
Oversees and directs the work of Quality Control Chemist who perform testing of raw materials, intermediates, and APIs in support of process development and manufacturing.
Conducts QC testing as required.
Interact with Plant Manager to assess Quality Control support needs and coordinates coverage for all shifts, assigns projects/ responsibilities, delegates analyses (as needed), reviews data.
Participates in deviation and OOS investigations
Develops, improves, and revises SOPs, test methods, and other GMP documentation as needed.
Assures compliance of laboratory operations and contributes to laboratory organization including calibration, qualification and re-qualification of instruments.
Leads the transfer of analytical procedures from the Analytical Development group as well as directly from the client sites.
Identifies and leads continuous improvement initiatives.
Communicates with internal and external clients.
Actively participates in quality and safety audits and walkthroughs.
Provides guidance and direction to other **MEMBERS ONLY**SIGN UP NOW***. Pharma Services (JMPS) staff in order to implement the quality vision for both JMPS sites.
Provides support to Devens or Andover, MA locations as needed.
To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
Are you the ideal candidate?
BS in Chemistry or equivalent with 5-6 years’ experience in Analytical and Quality Control in an API development and manufacture industry.
MS in Chemistry or equivalent with 4-5 years’ experience in Analytical and Quality Control in an API development and manufacture industry.
Knowledge and previous experience with GMP, ICH Q7
Extensive knowledge in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals.
Knowledge in organic chemistry
Experience with Microsoft Office and other complex computer software (Trackwise® and Empower)
Experience with a range of organic analytical chemistry techniques with particular emphasis on chromatographic methods. (HPLC, GC, Ion Chromatography, LC-MS)
Experience with titrations, KF, NMR, UV-VIS, FTIR, DSC and TGA