The QC Associate Senior (Analytical) is experienced with a wide variety of analytical techniques, international regulations, and method development and validation. This role will lead method transfer, development, and qualification projects. This role is proficient at summarizing data and presenting it to internal and external parties. This role works closely with people at Wacker Biotech USA, our sister sites, and clients, to ensure project commitments are met in a timely manner. This position will mentor other quality associates to support technical transfers, method validation, and quality investigations. This position requires hands-on laboratory work and close collaboration with the QC control team, Process Development Team, and the Operations team, and external clients. This position is expected to be highly knowledgeable of relevant cGMP guidelines, ICH Guidances, and other regulatory considerations.

Essential Functions of this Position

• Lead project groups to complete objectives in a timely manner. Manage project related schedules. Collaborates with Operations, Process Development, and external clients. Presents project progress and scientific updates to internal and external parties.
• Develop, qualify, and validate complex analytical test methods following international guidance's, and client requirements.
• Mentors quality control associates. Ensures personnel understand various analytical assays and standard operation procedures as well as conform to any departmental procedures.
• Develop and revise SOPs under data integrity guidelines as well as perform periodic revisions to ensure the procedures are up to date to current standards.
• Assist Quality Assurance in ensuring compliance with applicable quality standards and regulatory requirements.
• Lead QC initiatives. Develop and implement improvement projects seeking in-put from affected departments / parties as needed.

Position Qualifications

• Bachelor, Masters, or PhD of Science Degree in the Biological Sciences, Bioengineering or Chemistry with a combination of education and experience performing biochemistry, molecular biology, microbiology, and chemistry.
• 8+ years relevant experience with BS, 6+ years relevant experience with MS, or 0+ years relevant experience with PhD required
• Up to 5% travel
• The QC Associate Senior must be accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
• The QC Associate Senior must be capable of being highly independent, and able to accomplish tasks with minimal input.
• The QC Associate Senior must be capable of mentoring other quality professionals and working closely with other departments.
• The position is responsible for performing and demonstrating the highest form of quality in the pharmaceutical industry, understanding the cGMP regulations, and implementing these practices on the work being performed.
• Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
• Highly organized, detail oriented, with excellent record keeping skills.
• Sound scientific judgement with good communication skills and the ability to work effectively with others.
• Experience working in a GMP facility is highly desirable.
• Experience analyzing plasmid DNA is highly desirable.

The anticipated salary range for candidates who will work in San Diego is $106,000.00-130,000.00. 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