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QC Chemist I

Company: Catalent Pharma Solutions, Inc.
Location: San Diego
Posted on: June 13, 2021

Job Description:

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Quality Control Chemist I

Position Summary

The QC Chemist I will be responsible for performing various analytical techniques and common standard lab practices in order to assess the quality of pharmaceutical products under cGMPs (as applicable) and limited supervision. This position gives opportunities to broaden analytical understanding and learn the common operations in a fast-paced, early Phase-focused, dynamic Quality Control group.

This position will be located at our San Diego, CA location.

In concert with Catalent's Patient First philosophy, this position is key in our efforts toward continuous improvement of our processes & information which will allow quality drug products to reach patients safely and efficiently.

Catalent Pharm Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. We recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role (daily responsibilities)

  • Independent execution of various standard laboratory techniques, including but not limited to H/UPLC, dissolution per USP <711>, water content analysis per USP <921>, appearance assessment, water activity per USP <922>
  • Execution of more advances analytical techniques with assistance such as PXRD, DSC, FT-IR, TGA, and SEM
  • Independent preparation of samples, solutions, instrument set-up and breakdown
  • Independent preparation of data packets and creation of stability data sheets and Certificates of Analysis to summarize analytical testing
  • Assisted participation in Out of Specification investigations and the documentation of analytical deviations along with Qualified Investigators and management
  • Understanding of cGMPs, Catalent SOPs and Catalent systems applicable to work performed
  • Understand and apply ICH and FDA guidance
  • Proactively request assistance when needed to prevent deviations and investigations
  • Develop time management strategies to ensure work is performed within required timelines
  • Participate in technical discussions with supervisor and peers
  • Communicate with clients and intra-company personnel, including delivery of data and notification of OOS/OOT
  • Stay current with analytical technology industry standards and equipment
  • Begin to develop skills to interpret data and use conclusions to propose follow up actions for investigations and deviations
  • Begin to develop skills to review data packets for technical and compliance errors and demonstrate appropriate attention to detail

The Candidate (requirements)

  • B.S. degree in a scientific discipline, Chemistry or Biochemistry preferred
  • 0-3 years of applicable laboratory experience, some GMP exposure preferred
  • Effectively communicate with peers and interdepartmental colleagues
  • Demonstrate considerate and safe behaviors in the laboratory
  • Demonstrate accountability, attention to detail, and organizational skills

Catalent's standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits

  • Awesome employee activities: Movie day, Monthly Birthday Celebrations, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment
  • Environmentally friendly with on-site practices as well as regularly participating in Beach Clean-up activities
  • High visibility to Senior Leadership daily
  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually and eleven paid holidays;
  • Tuition Reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Keywords: Catalent Pharma Solutions, Inc., San Diego , QC Chemist I, Other , San Diego, California

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