QC Development Sr Associate Job Details | Wacker Chemie AG

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  Date: Aug 8, 2024

  Location: San Diego

  Company: Wacker BioTech US Inc.

  Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.

  To strengthen our team inSan Diego,

  we are looking for you as a(n)QC Development Sr Associate.

  The QC Senior Associate (Development) position will work as part of the QC team to support method transfer, development, qualification, and validation. The candidate will also provide analytical testing for samples at Wacker Biotech US. This position requires hands-on laboratory work and close collaboration with the Manufacturing, Process Development/Technical support, and Quality Assurance.

  Essential Functions:

• Develop, qualify, and validate complex analytical testing following international guidance's, and client requirements in accordance with project timelines.

• Perform data analysis, document results, and review GMP results and documentation.

• Perform analytical testing following established SOP's

• Present data and reports to internal teams as well as clients

• Train and ensure personnel understand various analytical assays and standard operation procedures as well as conform to any departmental procedures.

• Perform QC activities, organizing and prioritizing daily tasks, related to operations, technology transfers, analytical testing and validation including equipment and procedures.

• Assist Quality Assurance in ensuring compliance with applicable quality standards and regulatory requirements.

• Support method/instrument troubleshooting by working with QC analysts to determine the root cause and identify and implement appropriate corrective actions.

• Work with product development and manufacturing on tech transfer activities as well as provide support to any activities needed for commercial manufacturing.

  Position Qualifications:

• Bachelor of Science Degree in the Biological Sciences, Bioengineering or Chemistry with a combination of education and experience performing biochemistry, molecular biology, microbiology, and chemistry

• A minimum of 5+ years of experience performing quality control and/or development activities in the pharmaceutical and biotech industry

• 3+ years of experience working in a GMP facility.

• Up to 5% travel

• Strong understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products which could include HPLC, UV/Vis Spectroscopy, qPCR, Capillary Electrophoresis, Bioanalyzer, Place Readers, Gel Imagers, etc.

• In-depth experience related to method development, optimization, validation, and tech transfers.

• Demonstrated ability to manage and work independently on projects, and review project data and provide summary analysis reports based upon the data.

• A working knowledge of GMP compliance, pharmacopeia (USP, EP and ICH), and regulatory requirements.

• Strong communication skills, both written and verbal in the English language, and outstanding interpersonal skills are essential job requirements.

• Accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.

• 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.

• Strong scientific, analytical, problem solving, and communication skills as well as sound judgement, with the ability to work both independently and effectively with others.

  The anticipated salary range for candidates who will work in San Diego is $80,000.00-100,000.00. 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.

  What do we offer?

  WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions.

  WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.

• 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

  We are looking forward to your online application at www.wacker.com.

Reference Code: 27324

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The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.

A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card).

WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.