Senior Technical Specialist - Quality Control
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Leads the introduction of new methods and processes into the Quality Control (QC) department via the technology transfer process, represents the department on project teams, and provides technical support during investigations.
- Participates in the initial assessment of new products and processes.
- Provides input to program management regarding QC capabilities and requirements for method qualification/validation. Reviews applicable regulatory guidance and internal policy documents to ensure compliance.
- Provides technical review of Statements of Work (SOWs) to support contract manufacturing activities.
- Provides QC representation to project team meetings. Responsible for relaying pertinent information such as production schedules and information requests to applicable QC groups. Provides routine feedback regarding tech transfer and testing status. Supports stability program by gathering information needed to initiate protocols and tracks status of timepoint summaries. Relays status updates in a timely and accurate manner.
- Writes, reviews, and/or approves Test Records/Forms, Sampling Plans, and Specifications.
- Leads tech transfer activities related to QC including generation of a QC master transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines
- Works in cooperation with BioAnalytical Services to design qualification, and validation protocols.
- Performs QC assessment of new raw materials required to support GMP manufacturing and testing. Collaborates with MSAT, Manufacturing, and Quality Control SMEs to identify critical quality attributes of raw materials to identify appropriate testing in compliance with applicable site and Lonza quality policies. Writes, reviews, and approves raw material specification documents
- Leads part number request for QC materials required as part of assay transfer
- Assists with responses to audits, deviations, out of specification (OOS) investigations, and corrective/preventative actions (CAPA).
- Performs other duties as assigned.
- Bachelors degree in Sciences field of study required, Masters degree preferred
- Advanced knowledge in Quality Control
- Experience with method validation and technology transfer required.
- Knowledge of biological cell based assays such as proliferation/cell count and viability, flow cytometry, ELISA, and PCR preferred.
- Prior experience working with cell or gene therapy products a plus.
- Able to develop and deliver training programs for specialized and advanced activities. Trains trainers on how to develop effective on the job training.
- Aids in development of training plans and identification of training gaps.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Knowledge of SAP and TrackWise systems a plus.
- Uses experience and knowledge to solve problems, make decisions, and develop plans for the group. Makes recommendations for the department.
- Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
- Improves efficiency of self and team by clearly defining and analyzing problems and implementing new ways of approaching work.
- Demonstrated experience in management of complex tasks and projects.
- Skilled at establishing clear and understandable directions and goals. Escalates roadblocks to project/task completion.
- Able to prioritize own work and aid in setting group priorities.
- Strong organizational skills.
- Able to write complex procedures and reports.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management.
- Communicates expectations effectively to members on project teams and in area.
- Uses mediation skills to resolve or avoid conflict.
- Capable of leading teams and identifying appropriate path to meet team objectives.
- In conjunction with program management team, helps develop loyalty and trust with customers. Able to make and deliver on promises of projects within group control.
- Actively works to establish strong relationships within the group and with other department managers to improve harmonization and effectiveness.
- Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.
- Demonstrated leadership skills as well as team building and mentoring skills.
- Can be counted on to complete both routine work assignments and projects on time or ahead of schedule without routine reminders.
- Leads by example – models good behavior, work ethic, and teamwork.
- Champions change, speaking positively to and about others in all situations.
- Is optimistic and displays a positive attitude even during periods of adversity.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.