This position will be reporting to Manufacturing, Science, and Technology (MSAT) manager. The experienced-Level MSAT Engineer / Scientist will be responsible for supporting manufacturing operations in all aspects of plasmid DNA manufacturing, including fermentation, centrifugation, lysis, and chromatographic processes and by applying engineering knowledge to troubleshoot problems and improve production capabilities. The Senior MSAT Engineer / Scientist would be responsible for acquiring knowledge on pDNA, mRNA, protein, and other new biotechnology platforms to expand Wacker's service offerings.

The position entails Manufacturing Science and Technology (MSAT) responsibilities that include product and equipment technology transfer. The position will provide relevant input to the project core-team(s). The position ensures successful technology transfer from development (or small-scale process) to a larger production scale by being the production representative of an assigned operation step.

The Senior MSAT Engineer / Scientist maybe be responsible for more than one unit operation based on the number of years they have been in the industry and acquired bioprocessing knowledge. They will be responsible for providing training to operators upon complete the tech transfer process and perform the duties within the boundaries of EH&S and cGMP requirements, as well as clients expectations. The Senior MSAT Engineer / Scientist will lead projects and activities independent to ensure equipment and process are designed and procured to meet project timelines. This position will provide cross training to other engineers.

The Senior MSAT Engineer / Scientist is also responsible to ensure life-cycle management of a process from transfer, via process validation to continuous process verification. In addition, ensuring process related support to shopfloor for routine processes when needed.

Wacker is a safety-first culture, the Senior MSAT Engineer / Scientist will be responsible in maintaining a safe work environment, following all safety rules and wearing appropriate PPE when needed. Identifying any potential safety issues and reporting such issues and assist in rectifying, if applicable.

Essential Functions of the Position:

• Act on the interface between development and production especially with respect to technology transfer.
• Participate in boards and project core-teams, and act as focal point for other departments (representative of production). The position requires the individual to be the subject matter expert (SME) of their assigned process and provide relevant input to the tech transfer project. The position is responsible for successfully scaling up and introducing a new process into the GMP manufacturing facility.
• Accurate assessment of the status of a project when GMP-introduction is proposed, including keeping, together with the rest of the project core-team, the risk assessment (a living document) of the project up to date.
• Ensure, for validated processes, that the relevant continuous verification program is in place, executed and reviewed.
• Ensure process batch records, operating procedures and processes are cGMP compliant and receiving input from the relevant departments and groups (engineering, technical and quality group, manufacturing) to ensure the same for equipment.
• Execute processes and record, calculate, control and review MSAT data and GMP production data in a manner that is accurate, timely, complete, factual, and clear.
• Perform post campaign process evaluation leading to either generate Technical Report or intermittent recommendations for operational improvements.
• Perform troubleshooting and optimization activities for the production processes including deviation analysis from a technical / scientific / process-related point-of-view in close collaboration with the quality department.
• Identify opportunities and propose improvements/investments that lead to higher quality or efficiency of the organization.

Position Qualifications

• B.S. in Chemical Engineering or Scientific Study required (Master's or PhD preferred)
• 9 years of experience required with B.S. (or 7 years with Master's, or 4 years with PhD)

The anticipated salary range for candidates who will work in San Diego is $106,000.00-135,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi state employer and this salary range may not reflect positions that work in other states.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement