Job description
Overview:
What we do.
How we do it.
Job Summary: Lead technical support to the Manufacturing and Quality organizations. Partner closely with other Technical Experts and Regulatory on introduction and integration of new products, processes and formulations. Responsibilities:
Scope:
Who we are.
Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.
If you are looking to positively impact the lives of patients, we want you to join our team.
What we do.
- Vision – Pioneering the future of immunotherapy.
- Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.
How we do it.
The Dendreon Way. We are a purpose-driven, value-based culture. At Dendreon, we…
- Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer.
- Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
- Build Trust: Building trust takes time. Engage teammates, be candid and transparent.
- Raise the Bar: Harness continuous improvement, foster innovation and elevate our people.
- Drive Results. Be accountable and execute – we win when everyone performs.
Are you ready?
Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.
Job Summary: Lead technical support to the Manufacturing and Quality organizations. Partner closely with other Technical Experts and Regulatory on introduction and integration of new products, processes and formulations.
- Functions as technical expert for process deviations
- Provides assessment of potential product impact as well as possible cellular contributing root cause determination using a variety of tools.
- Supports technology transfer activities, facility fit assessments and new product introductions.
- Generates protocols and reports to support process and equipment validation activities for cell therapy processes at the IMF (Immunotherapy Manufacturing Facility) as required for CMS (Commercial Manufacturing Services) related projects.
- Monitor equipment and manufacturing process reliability using statistical analysis to inform process improvement initiatives.
- Support and maintain process equipment life cycle through design, procurement, commissioning and qualification, maintenance, and decommissioning phases.
- Provides technical training and guidance to staff members on processes and equipment.
- Supports development and process characterization studies.
- Supports evaluation of new technology and process equipment for GMP manufacturing.
- Author or support risk assessments, FMEAs, and change controls related to changes to manufacturing processes.
- Provide cross-departmental support to Facilities & Engineering, Manufacturing, and Quality
- Represents function as Subject Matter Expert in audits and regulatory inspections as needed.
Scope:
- Uses professional concepts, company policies and procedures to solve a variety of problems.
- Works on problems of complex scope in which analysis of situation or data requires a review of identifiable factors. Introduces applicable principles to the function and orients them on appropriate usage. Establishes new principles with usage guidelines and training as appropriate.
- Works with minimal supervision.
- Minimum of bachelor’s degree in a scientific discipline or equivalent.
- Typically 4-6 years of related experience.
- Typically 2-4 years of GMP experience.
- Understanding and experience using risk management and risk assessment methodology.
- Understanding and experience using Root Cause Investigation methodology.
- Strong communication (verbal and written) and organizational skills required.
- Proficient in MS Office applications.
Working Conditions and Physical Requirements:
- Ability to sit or stand for extended periods of time.
- Intermittent walking to gain access to work areas.
- Finger dexterity sufficient to use a computer and to complete paperwork activities.
- Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
- Hearing sufficient to communicate with individuals by telephone and in person.
- Ability to lift up to 50 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
- Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
- May be required to work alternate shifts.
- Occasional travel may be required.
- Ability to gown aseptically for work in Clean Room environments.
- Job performed in a lab, office, or utility (noisy) environment.
- Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.
- Dendreon is an EEO/AA employer M/F/D/V.
colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, colinoncars.com is the ideal place to find your next job.