Seagen
Senior Specialist, Site Document Control - Launchpad
Corporate Functions - Bothell, United States
Description
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Summary:
Seagen’s new cGMP manufacturing facility “project Launch Pad” is being built in Everett, Washington, just North of Seattle. Launch Pad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).
The Document Management Sr. Specialist is responsible for owning and managing both non-GMP and GMP business processes supporting the lifecycle of documents that includes author, review, issuance, approval, and archive of non-GMP and GMP documents at Seagen’s new manufacturing site (Drug Substance, Drug Product, Testing, Labeling and Packaging) in Everett, WA.
The responsibilities include implementing the corporate requirements for the Document Control program; making decisions within the scope of the document management program; providing customer service and user support at the site by providing guidance and tools; developing metrics and assessing performance against them; authoring and collaborating on non-GMP and GMP controlled procedures within scope of responsibility; participating on cross-functional or external teams and continuous improvement activities; participating as Document Control Subject Matter Expert (SME) in site audits and inspections; interfacing with business process owners and department heads at Project Launch Pad that author; reviewing and approving GMP and non-GMP documents; and handling vendor submittals, turnover packages, CQV documents, and other site-related documentation.
Principal Responsibilities:
- Manage and perform site activities within the GMP and non-GMP Document Management program, including:
- Leading discussions with junior to mid-level staff on performing document management assessments and activities
- Developing and providing training for document management
- Developing new business processes
- Developing new metrics, and evaluating and reporting them to department management
- Participating in GMP and non-GMP activities as a business process owner
- Participate and support as the site Document Control SME in audits and inspections, as needed
- Participate in continuous improvement activities that may involve a team for document management at the site
- Make independent decisions within the areas of expertise, with support from management on more complex issues
Mentor entry-level associates
- Manage lifecycle of Launch Pad of GMP and non-GMP documents used to support manufacturing, testing, and operation of the facility
Other duties as assigned
Required Qualifications:
- 5+ years in manufacturing and operations, preferably in the biopharmaceutical or the pharmaceutical industry
- Working knowledge of ICH guidance, regulatory guidance, and pharmaceutical organization guidance
- Advanced expertise with Office 365, especially Excel
- Experience with applicable software (e.g., electronic Document Management System)
- Knowledge and execution of physical and electronic Document Management workflows and principles
- Knowledge of GMP and non-GMP documentation lifecycle and requirements for each phase of the document(s)
- Knowledge of good documentation practices within the Pharma or Biopharma industries
- Basic knowledge of continuous improvement principles and practices
- Excellent written and oral communication skills
- Demonstrated problem-solving skills and techniques commensurate with job level
- Ability to manage routine and non-routine workload with little-to-no routine oversight
- Bachelor's degree in relevant field
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.
The hiring pay range for this position is $107,000 to $138,600 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 01/27/2023
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