Lead Formulation Technician, Manufacturing

Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy Contract Development and Manufacturing Organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven proficiencies and strong character to join our team and help lead our organization into the future.

• Address: 250 Binney Street Cambridge, MA
• Shift Schedule: 12 Hour Rotating Shift (2/2/3 format) 6:45-7:15

How will you make an impact?

The Lead Formulation Technician in this role will be part of a cohesive team responsible for suite readiness for all phases of manufacturing, serves as the subject matter expert of operations and operates as the tactical lead technician on the floor in manufacturing drug product injectables in a cleanroom environment and ensure that the team follows GMP standards, processes, and schedules The Lead Formulation Technician will review batch records for accuracy and completeness. Train and mentor junior associates coordinating with team leader. Gives feedback for ongoing training needs, operation effectiveness and process improvements to team leader and supervisor. Lead activities in particular rooms with coordination of Team Leader and supervisor including interpreting and driving the schedule. Participate in investigations..

What Will You Do?

• Serves as the subject matter expert on the floor providing guidance to other technicians and driving daily operations. Monitors all operations of designated formulation process to ensure safety procedures, quality standards and compliance with regulatory requirements. Adheres to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies.
• Expert level skill & qualified trainer for: Aseptic Gowning / material flow, Applicable processing equipment, SAP/BLV. Works on assignments requiring considerable judgment and initiative. Understands implications of work and makes recommendations for solutions and improving processes with operations.
• High impact to work; affects the work of people on the team. Assists management with determining new methods and procedures on new assignments. Serves as informal team leader.
• Stays up to date on required job training and serves as the subject matter expert on operations assigned.
• SME or Expert on at least 2 unit Operations.
• Administers, documents and maintains the Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems tools, as well as direct actions.

• Review, revise, & author manufacturing batch records. Collaborate with Quality & PD to review & signoff on batch records. Own the batch record reconciliation. Review, revise, & Author WIs/SOPs.
• Adhere to the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well. Assist with the on time closure of Nonconformance’s/ CAPAs.
• Lead PPI initiatives and continuous improvements.
• Work with Team Lead and supervisor on ways to improve performance.
• Gives feedback at daily huddles and Tier 1 meetings to support operations and drive accountability. Step in to lead team in absence of Team Leader.
• Responsible for ensuring schedules are executable from an equipment, raw material and documentation perspective.
• Support of client PIPs and Audits.
• SME review of and add input to in-works manufacturing batch.
• Maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations. Ensure chemicals are properly stored and labeled.
• 90% of time spent on the floor
• Seeks and welcomes feedback and responds to coaching.
• Provides frequent feedback and coaching to others on ways to improve performance.
• Recognizes and celebrates successes.

How will you get here?

Education:

• High school or STEM/Biotechnology certificate preferred.

Preferred Experience/ Skills:

• 5 years of industry experience with 1 year of this being demonstrated leadership ability; or Bachelor’s degree and 2 years of experience with 1 year of this being demonstrated technical leadership experience.
• An equivalent combination of education and experience may be considered.
• Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).
• Thorough knowledge of cGMPs.
• Strong interpersonal and communications skills (written and oral).
• Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.

At Thermo Fisher Scientific, each one of our 100,000+ outstanding minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.