Engineer/Scientist II, QC

at  Thermo Fisher Scientific

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

The Engineer/QC Scientist II will be responsible for managing stability related project activities for both commercial and early phase products. The individual will attend customer project meetings to identify the scope of stability activities and will work directly with the customer and internal analytical representatives to craft the stability studies. The role provides direct support to ensure compliance with regulations that govern the pharmaceutical stability program.

EDUCATION:

• Bachelor’s degree required, preferably in Chemistry, Biology, or other technical science related field.

QUALIFICATIONS:

• 3+ years of proven experience in a Quality function in the pharmaceutical industry is required. Some level of experience with stability related activity is helpful.
• Equivalent combinations of education, training, and relevant work experience may be considered
• Multiple digital literacy including working experience with MS office applications such as Word and Excel and general experience in computer systems associated with quality such as SOP and document review.
• Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and clients. Highly effective verbal and written communication skills.
• Outstanding attention to detail and interpersonal skills. Self-starter, mature, independent and diligent. Ability to work in a fast-paced environment under pressure, able to multi-task and is results oriented.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and typing. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials. Ability to sit, reach with hands and arms, talk, and hear. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

• Managing all stability activity for projects of mid-level complexity
• Writing Stability Protocols
• Building Stability Frameworks in SampleManager 12 and SLIM
• Coordination of batch identification, receipt, labeling and storage of stability studies
• Generation and issuance of Stability Reports to the customer
• Initiating billing requests for stability related activities
• Communicates and coordinates with other departments as the need arises to resolve issues related to stability activities
• Makes decisions regarding regulatory requirements around stability
• Ensures adherence to current regulations with little dependence on others.