Job description
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. Over communicate and seek feedback.
- Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
- Drive Results. Be accountable and execute – we win together when everyone performs.
Are you ready?
Your Role:
In this role you will be responsible for leading process sciences tech transfer activities for PROVENGE and partner programs and will be highly involved with the process development and design space for partner programs. You will work closely with cross functional groups; analytical sciences, quality, regulatory, project management and quality control.
Functional Area: Tech and Program Ops
Responsibilities:Your Work:
- Overseas PROVENGE support related to manufacturing process, process optimization, alterations, review and testing of manufacturing materials and process changes.
- Works with the cross functional, multi-product Dendreon operations teams.
- Actively supports process development and tech transfer activities.
- Responsible for seamless transition and startup of clinical GMP manufacture of partner programs.
- Supports business development with technical expertise during initial client calls.
- Provides manufacturing support related to partner programs.
- Establish and maintain effective relationships with key stakeholders and clients to ensure successful manufacture and issue resolution.
- Provides management with business intelligence and reports for key business performance indicators.
- Involved in evaluating technologies and able to put together a high-level proposal.
- Maintains up-to-date knowledge of new equipment and technologies in the industry.
- Other duties as assigned.
- Uses professional concepts and company policies and procedures to solve a variety of problems.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Strong understanding of the end-to-end process and is able to discern priorities, escalate issues and manage exceptions.
- Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations
- Adapts well to a changing environment, is recognized as a team player internally and externally and provides strong customer service to the plant.
- Ensures self and team are always current with new/changing information/guidance and supports the MFG ops manager in day-to-day activities.
Education Requirements
- Doctoral degree or equivalent.
- Preference to biological sciences, such as cell biology or immunology.
- Bachelor’s degree in similar field with significant leadership experience would also be considered.
Job Requirements:
- 15 years related experience with operations management and process development activities.
- 10 years biopharmaceutical experience preferred.
- Proficient with aseptic technique, upstream processing, cell banking and single use automated equipment.
- Proficient in MS Office applications.
- Strong leadership capability required.
- Ability to drive high performing teams.
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 regularly lift 10 – 20 lbs. and lift up to 50 lbs. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
- May be required to work alternate shifts
- 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.
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