Senior Manufacturing Associate will be responsible for supporting manufacturing operations by leading operators in all aspects of plasmid DNA and protein manufacturing including cleaning, sanitization, dispensing, media/buffer formulation, cell expansion/transformation/banking, fermentation, centrifugation, lysis, UF/DF, filtration, chromatography processes, and final filtration and by applying best cGMP practice knowledge during manufacturing processes. Lead set-up, operation, cleaning and break-down of process equipment. Under little to no supervision, capable of performing, troubleshooting, and monitoring critical manufacturing processes and following current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and data integrity practices within a cleanroom environment. Expected to demonstrate expert understanding and troubleshooting knowledge in operating automated systems, setting up and using disposable single-use and multi-use stainless steel pharmaceutical systems, drafting, revising, initial reviewing, and following written Standard Operating Procedures (SOP's), Material Specifications, Batch Records (BR's)/logbooks, performing and monitoring in process sampling and testing (pH, conductivity, weighing, OD600/AU, filter integrity) and conducting routine cleaning and sanitization tasks (Glass-wash, Autoclave, COP, CIP, SIP) to maintain equipment in a clean controlled state. Expected to demonstrate aseptic processing techniques.

Expected to follow safety policies by playing an active role in identifying and correcting unsafe behaviors and conditions.

Essential Functions of this Position

• Serves as a Subject Matter Expert (SME) for functional area operations.
• Assist senior staff and supervisor to schedule operations.
• Lead manufacturing operations on the production floor.
• Participates in production readiness and ensures timely setup of cleanroom equipment and all necessary resources for each production run.
• Dispense raw materials and disposable materials, and prepare media and buffer solutions according to batch records and SOP's
• Provide training to manufacturing staff on operations and process theory. And Ensure that training records are reviewed and regularly updated.
• Lead manufacture of bulk drug substance through various manufacturing unit operations, which include cleaning, sanitization, dispensing, media/buffer formulation, cell expansion/transformation/banking, fermentation, harvest, lysis, filtration, chromatography, and final bulk.
• Lead operation of small-scale single-use and large-scale multi-use stainless steel fermenters, centrifuges, lysis/depth filtration skids, Ultrafiltration/Diafiltration (UF/DF) skids, and chromatography skids/columns and bulk filtration.
• Cross train and be proficient in all areas of manufacturing. Be able to perform and oversee all aspects of USP and DSP production operations as operator or verifier.
• Perform sterile filtration and filter integrity testing (FIT). Understand results and assist in troubleshooting.
• Perform Clean in Place (CIP), Steam in Place (SIP) and sanitization of equipment using automated systems according to SOP's. Understand results and assist in troubleshooting.
• Clean out of Place (COP)/Glass-wash/Autoclave of misc. parts and equipment. Lead planning and scheduling of activity.
• Document all activities and results accurately, completely, and contemporaneously in batch records and logbooks. Ensures ALCOA principles are followed.
• Monitor and record process parameters, such as temperature, pressure, pH, conductivity, OD600, etc. Leads data trending and lessons learned.
• Identify, report, and own any deviations, problems, or issues that may affect product quality or safety and own Corrective and Preventive Actions (CAPA) to quality incidents.
• Draft, revise, and own controlled documents (SOP's, Batch Records, Material Specifications, Technical Protocols, etc.)
• Review logbooks and batch records for adherence with Good Documentation Practices.
• Lead in identifying process improvements and coordinate interaction with other departments to implement.
• Work with engineers and other departments to develop, implement and validate new processes and procedures, troubleshoot equipment, and optimize overall system performance.
• Troubleshoot equipment and process failures. Recognize common equipment failures and process anomalies.
• Lead deviation investigation, corrective action, preventative action and document training.
• Work with engineers and other departments to implement technology transfer from PD to cGMP operations.
• Assist the facilities and metrology department during periodic plant shutdowns to coordinate equipment maintenance and instrument calibration. Verifies against production schedule and performs risk mitigation assessments.
• Schedule adherence and dependability. Has accountability.
• Some after-hours work and participation in the rotating after-hours process control function will be required.
• Sponsors lean initiatives to facilitate continuous improvement.

Position Qualifications

• Associate's degree in sciences required; Bachelor's degree in sciences or related discipline preferred

• 10+ years of industry expereince in cGMP manufacturing pharmaceutical / biotechnology GMP facility with an Associates Degree or 6+ years with a Bachelors Degree
• Experience working with pilot or commercial scale processing equipment such as stirred tank bioreactors, continuous flow centrifuges, ultrafiltration skids, process tanks, automated process equipment, and automated CIP/SIP systems.
• Experience working on cross functional teams and a commitment to working in a fast-paced environment.
• Experience working in a cGMP environment, including in-depth knowledge of current Good Manufacturing Practices, validation, process engineering, quality system regulations, and ISO standards. Knowledge in 21 CFR - Parts 210 and 211.
• The ability to communicate clearly and precisely, both orally and in writing.
• Confident, initiative, strong interpersonal and collaborative skills, and good personal organizational skills.
• Ability to independently identify problems and effectively offer solutions to problems.
• Ability to work on multiple tasks simultaneously and meet project deadlines.
• Proficient computer skills in Microsoft Word, Excel, SharePoint, and Power Point.
• Flexibility and adaptability.

Ability to work different shifts and handle changing priorities and schedules.

• Safety awareness and compliance. Ability to follow safety policies

The anticipated salary range for candidates who will work in San Diego is $85,000.00-120,000.00. 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