JOINN Biologics is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry.
We are seeking a Project Manager to JOINN US and support our growing family! This role will be responsible for total project management and delivery of complex research, development, and production projects from the proposal stage through to successful project completion, in close collaboration with clients, partners, internal business units, and other key stakeholders.
Duties and Responsbilities:
- Leads cross-functional project coordination with technical, engineering, production, facility, quality, business development, marketing, and other related business units, and manages overall integration of project activities to complete projects on time, within budget, to specifications, and with accuracy and efficiency.
- Establishes project goals within broad outlines provided by top management, directs project design, outlines and delegates tasks involved, and reports progress to all key stakeholders.
- Develops and implements policies, standards, and procedures for project management.
- Assesses project feasibility by analyzing technology, resource needs, and market demand; investigates project challenges; implements corrective measures; evaluates results; and makes recommendations for future improvement.
- Conducts cost analysis, estimating expected costs for projects.
- Recommends, prepares, and implements project budgets, bids, and contracts based on estimates.
- Acts as a liaison between the Company, partners, clients, and vendors; manages day-to-day, real-time communications and expectations to all stakeholders; and cultivates client relationships.
- Organizes project meetings, prepares agenda and minutes, and follows up on action items.
- Consults and negotiates with clients to prepare project specifications.
- Presents and explain proposals, reports, or findings to clients.
- Addresses questions, concerns, and complaints throughout projects.
- Ensures compliance with federal, state, local, industry, contractual, and Company regulations, standards, specifications, and best practices.
- Performs other duties as assigned.
- Bachelor's degree in Biological Sciences, Chemistry or related, or equivalent experience.
- 5+ years' relevant biotech and/or pharmaceutical industry experience in Chemistry, Manufacturing, and Controls (CMC) process development and current Good Manufacturing Practice (cGMP) manufacturing.
- 5+ years' experience in project management or external research collaboration management of biological molecules.
- Experience in managing multiple complex projects and total project delivery in a cGMP manufacturing environment.
- Experience in a Contract Manufacturing Organization (CMO) or Contract Research Organization (CRO).
- Experience in technical transfer.
- Understanding of the functional requirements of pharmaceutical facilities and technical, engineering, and manufacturing best practices.
- Understanding of federal, state, local, and industry, cGMP, regulatory, environmental, and safety, federal, state, local, industry, regulatory, environmental, and safety regulations,
- Hands-on client experience, including negotiation and management of bids, contracts, and agreements.
- Excellent presentation and verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent organizational skills, attention to detail, and ability to maintain a high level of accuracy.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Strong supervisory and leadership skills.
- Ability to prioritize tasks and to delegate them when appropriate.
- Ability to work independently and collaborate as part of a cross-functional team.
- Thorough understanding of or the ability to quickly learn about the project or product being developed.
- Proficient with Microsoft Office Suite (Excel, Outlook, Word, and PowerPoint), Enterprise resource planning (ERP), and project management software.
- Equivalent education and experience may substitute for stated requirements.
- SAGE X3 ERP experience.
- Bilingual (English/Mandarin) communication skills (written and spoken).
Location: Richmond, CA 94806
Work authorization: United States (Required)