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Sr. Specialist/ Manager, Quality Control and Stability Management, Analytical Development - CMC

Redwood City, CA 94063

Posted: 09/23/2022 Employment Type: Contract To Hire Job Category: Quality and Compliance Job Number: 509797-1 Country: United States Is job remote?: No

Job Description


The Opportunity:

  • Coordinate stability activities, including but not limited to monitor schedule, data entry, trending, review and presentations/reports.

  • Track stability studies, maintain stability database.

  • Oversee outsourced stability studies at CDMOs and or contract testing labs.

  • Manage quality events related to stability studies such as lab investigation, deviations, change controls, CAPAs.

  • Author and / or review stability related documents, including protocol, report, and memos.

  • Manage reference materials including monitoring retest date, facilitating qualification/requalification, tracking inventory.

  • Provide support to quality systems and documentation as needed.

  • Collaborate with cross functional teams including Process R&D, Pharmaceutical Development, Toxicology, and Quality Assurance to timely achieve project goals.

Required Experience, Skills and Education:

  • BS or MS in Life Sciences, Chemistry or related discipline.

  • 6+ years of relevant industrial experience in analytical development/QC with 2+ years experience managing stability studies.

  • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to stability study in small molecule drug development.

  • Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).

  • Effective written and verbal communication skills and interpersonal skills.

  • Extensive knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.

  • Strong problem-solving skills with sound technically driven decision-making ability.

  • Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

  • Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

  • Ability to multi-task and thrive in a fast-paced innovative environment.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com, @theplanetforward.com, @planet-technology.com, @planet-pro.com, @planetinteractive.com, @pfes.com, @launchcg.com, @planet-pharma.com, @planet-healthcare.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Redwood City, CA

Ready to embark on an exciting career opportunity in the vibrant area around Redwood City, California? Nestled in the heart of Silicon Valley, this thriving region offers a perfect blend of innovation, growth, and charm. From the bustling tech scene to the serene beauty of Redwood City's parks, like Edgewood Park and Pulgas Ridge Preserve, there's something here for everyone. Immerse yourself in the local culture by visiting the Fox Theatre or exploring art galleries like The Art Center and Redwood City Art Kiosk. With a bustling food scene offering everything from trendy cafes to authentic Mexican cuisine, it's no wonder that Redwood City is a top choice for job seekers looking to thrive in a dynamic environment. Browse our job listings today and take the next step towards a fulfilling career in this captivating locale!
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