Avid Bioservices Inc., located in Tustin CA, is a dedicated contract development and manufacturing organization (“CDMO”) focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture.
Avid provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.
With over 28 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, Avid’s services include CGMP clinical and commercial product manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support.
Avid also provides a variety of process development activities, including 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 todayCheck out our website at https://avidbio.comIn compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.Covid-19 Hiring Update: We are continuing to interview and hire during this time.
Avid Bioservices’ is committed to caring for the safety and well-being of applicants and employees; all interviews will be completed over the phone or virtually.Summary/Objective: The Avid Bioservices Information Technology team delivers and supports a wide range of mission-critical corporate and GxP systems.
The team takes a quality-first service approach to computer systems validation, equipment validation, data governance, IT compliance, SOX compliance, and laboratory informatics.
The Project Manager position is a highly visible leadership role expected to establish and deliver business value to the company.
Essential Duties and Responsibilities: Set and Manage Business ExpectationsDefine project objectives, impact, and critical success factors.Educate team on implementation methodology and deliverables.Develop, maintain, and communicate the project planManage vendors, SOW scope, budget, and timelineUnderstand software limitations and align expectations to software capabilities.Realistically assess and triage business requests and discourage high-risk customizations.Facilitate open and honest project progress assessments and disclose unanticipated difficulties as soon as possible.Distribute information to team members in a timely fashion.Proactive and Transparent Project LeadershipLead meetings and actively contribute to project discussions with team members, Steering Committee, Project Sponsor, and other department leads.Articulate project solutions on a business level and welcome project questions and concernsMonitor progress to ensure requirements are fulfilled on timeManage important activities and deliverables (business process design, user training, etc.)Educate business teams on change management strategies and help guide themIncrease project clarity by identifying issues and communicating them in a timely fashionManage out-of-scope itemsProject AdministrationChampion, create and manage quality SOX audit evidenceManage SOW contracts and approvalsReport on Project Financials (e.g., Budget vs Actuals)Resource Scheduling and Availability Issue ResolutionDesign and follow problem escalation proceduresAdministrative functionsEducation and Experience:5 years of relevant work experience in project management.
Previous experience with enterprise software solutions a must.BS degree in Systems Engineering, Business Management, Management Information Systems or equivalent.Experience working in a highly regulated public company with SOX and GxP standards strongly preferred.PMP certification strongly preferred.Experience with Change management, Business Process Design, Product training experience preferred.Experience with testing methodologies, Waterfall Development, Agile Development Methodology preferred.Must possess outstanding communication and presentation skills, issue resolution, coaching, task estimation, ability to influence and lead change.Work Schedule and Hours:This role is a full-time position.
Days of work are Monday through Friday, unless otherwise stated by Supervisor.
The employee must also, if instructed to, have the ability to work overtime and/or weekends when necessary.
Position is based in Tustin, CA.Employee Benefits:Medical, Dental, Vision, Life, and Long-Term Disability Insurance401(K) PlanEmployee Stock Purchase Plan (ESPP)15 Days PTO, 8 Designated Holidays, and 4 Floating Holidays per yearTuition Reimbursement ProgramAnd more Check out our Total Rewards package at https://avidbio.com/careers/EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYERAvid 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 protected veteran status.