Senior Manufacturing Science, and Technology (MSAT) Engineer / Scientist

$106,000 - $135,000/Yr

Wacker Biotech GmbH - San Diego, CA

Full-time - Senior

Hybrid - San Diego, CA

About the position

As a Senior Manufacturing Science and Technology (MSAT) Engineer/Scientist at Wacker BioTech US Inc., you will play a crucial role in supporting manufacturing operations related to plasmid DNA (pDNA) production. This position requires a deep understanding of various bioprocessing techniques, including fermentation, centrifugation, lysis, and chromatographic processes. You will leverage your engineering expertise to troubleshoot issues and enhance production capabilities, ensuring that our operations meet the highest standards of efficiency and quality. Your responsibilities will include overseeing the technology transfer process from development to large-scale production, acting as the production representative for assigned operations. You will be expected to provide training to operators post-technology transfer and ensure compliance with Environmental Health & Safety (EH&S) and current Good Manufacturing Practices (cGMP). Additionally, you will lead projects independently, ensuring that equipment and processes are designed and procured to meet project timelines. In this role, you will also be responsible for the life-cycle management of processes, from transfer through validation to continuous verification. You will provide process-related support to the shop floor as needed, maintaining a safe work environment by adhering to safety protocols and identifying potential safety issues. Your participation in project core teams will require you to act as a subject matter expert (SME) and provide relevant input to ensure successful project execution. You will be involved in assessing project statuses, maintaining risk assessments, and ensuring that all processes are compliant with cGMP standards. Your contributions will be vital in driving operational improvements and ensuring the successful scale-up of new processes into our GMP manufacturing facility.

Responsibilities

• Support manufacturing operations in all aspects of plasmid DNA manufacturing, including fermentation, centrifugation, lysis, and chromatographic processes.
• Apply engineering knowledge to troubleshoot problems and improve production capabilities.
• Acquire knowledge on pDNA, mRNA, protein, and other new biotechnology platforms to expand service offerings.
• Act as the production representative for technology transfer from development to larger production scale.
• Provide training to operators upon completion of the technology transfer process.
• Ensure compliance with EH&S and cGMP requirements during all operations.
• Lead projects and activities independently to meet project timelines.
• Provide cross-training to other engineers.
• Ensure life-cycle management of processes from transfer to continuous process verification.
• Support shop floor operations for routine processes when needed.
• Maintain a safe work environment by following safety rules and wearing appropriate PPE.
• Identify potential safety issues and assist in rectifying them.

Requirements

• B.S. in Chemical Engineering or a related scientific field required; Master's or PhD preferred.
• 9 years of experience required with a B.S. (or 7 years with a Master's, or 4 years with a PhD).
• Strong understanding of bioprocessing techniques and cGMP compliance.
• Experience in technology transfer and process validation.
• Ability to lead projects and work independently.
• Excellent problem-solving skills and attention to detail.

Nice-to-haves

• Experience with mRNA and protein production processes.
• Familiarity with risk assessment and management in a manufacturing environment.
• Strong communication and teamwork skills.

Benefits

• 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