Avid Bioservices
  • 26-Jul-2018 to 31-Oct-2018 (PST)
  • Business Operations
  • CA, USA
  • Salary
  • Full Time

Medical, Dental, Life, LTD, Vision Insurance and 15 days PTO per year, Plus 8 Designated Holidays, 4 Floating Holidays and 401k, ESPP and Pet Insurance


Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization.

We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today!

Summary:

Support the project management team effort for the projects as assigned by planning and coordinating cross-functional activities of designated project(s) to ensure that goals or objectives of project(s) are accomplished within prescribed time frame and funding parameters. Functional involvement includes but is not limited to facilitating activities related to quality, operations, facilities, regulatory, clinical, pre-clinical, and Chemistry/Manufacturing/Controls.


Essential Duties and Responsibilities include the following:

  • Supports the project management team implementation of standardized templates, project governance, project process flow, and resource allocation tools and techniques.
  • Supports the planning/preparation/facilitation of extended meetings (process validation, pre-BLA, commercialization plan review, etc.).
  • Supports project readiness activities related to process validation and commercialization (documentation, schedule, resources, risk assessment, budgeting, and ability to function as a member of PIP team during engineering and process validation runs).
  • Supports project interface with operations/outside contractor/supply chain for commercial production readiness, schedule and facilitate sub-team (as assigned) meetings.
  • Provides project management support to all assigned projects including oversight of project charter, project plan/timeline, risk management and risk elevation, project monitoring, and project closure.
  • Responsible for effective meeting facilitation, maintenance of meeting minutes, and action item generation, follow-up, and elevation for all assigned projects.
  • Supports the high-level management of facility expansion and corporate initiatives.
  • Back up for Sr. Project Management activities.

Qualifications:

Basic qualifications are B.S. /M.S. in a scientific discipline with a minimum of 2 years of biotechnology or pharmaceutical experience in a project management role. Project Management certification is desirable. Proficiency in MS Project is required. Attention to detail, ability to multi-task, familiarity with the drug development process, and strong written and oral communication skills are required.

Travel:

Occasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

 

Avid Bioservices
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