Manufacturing Associate I will be responsible for supporting manufacturing operations by working as an operator in all aspects of plasmid DNA or protein manufacturing including cleaning, sanitization, dispensing, media/buffer formulation, cell expansion/transformation/banking, fermentation, centrifugation, lysis, filtration, and chromatography processes. Perform set-up, operation, cleaning and break-down of process equipment. Under the guidance of senior staff, supervisor, or trainer, capable of performing manufacturing processes and following current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and data integrity practices within a cleanroom environment. Expected to demonstrate basic understanding and knowledge in operating automated systems, setting up and using disposable single-use and multi-use stainless steel pharmaceutical systems, following written Standard Operating Procedures (SOP's), Batch Records (BR's)/logbooks, performing 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 unsafe behaviors and conditions.

Essential Functions of the Position:

• Participates in setup of cleanroom equipment and all necessary resources for each production run.
• Dispense raw materials and prepare media and buffer solutions according to batch records and SOP's
• Manufacture 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.
• Operate 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.
• Cross train and have basic knowledge in all areas of manufacturing. Be able to perform all aspects of USP and DSP production operations as operator or verifier.
• Perform sterile filtration and filter integrity testing (FIT).
• Perform Clean in Place (CIP), Steam in Place (SIP) and sanitization of equipment using automated systems according to SOP's.
• Clean out of Place (COP)/Glass-wash/Autoclave of misc. parts and equipment.
• Document all activities and results accurately, completely, and contemporaneously in batch records and logbooks, following ALCOA principles.
• Monitor and record process parameters, such as temperature, pressure, pH, conductivity, OD600, etc.
• Identify and report any deviations, problems, or issues that may affect product quality or safety.
• Draft or revise SOP's and batch records.
• Review logbooks for adherence with Good Documentation Practices.
• Work with other manufacturing associates and engineers to implement and validate new processes and procedures, troubleshoot equipment, and optimize overall system performance.
• Assist the facilities and metrology department during periodic plant shutdowns to coordinate equipment maintenance and instrument calibration.
• Schedule adherence and dependability
• Some after-hours work and participation in the rotating after-hours process control function will be required.
• Participate in continuous improvement initiatives and training programs to enhance skills and knowledge.

Position Qualifications:

• Minimum of an Associate's degree in sciences, Bachelor's degree in sciences or related discipline preferred
• Minimum of 2 years experience in cGMP manufacturing pharmaceutical/biotechnology environment required with an Associates degree, 0+ years of experience with a Bachelor's
• 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.
• 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.
• Basic computer skills in Microsoft Word, Excel, 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 $31.73-34.00/hour. 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