Senior Project Manager - Drug Combination (JP5214)
Thousand Oaks, Ca.
2 years contract with possible extension or hire.
CMC Integration LCM PM
3Key Consulting Inc. is looking for role for a Senior Project Manager
with 5+ years’ experience in execution of development projects for Drug Substances and/or Drug Products. This opportunity is for a global, CA-based, bio-pharmaceutical company. Ideal candidate would have 5-6 years of Project Management experience In Pharma/Bio space, has combination product and design control experience, and PM certification preferred. Candidate needs to be onsite at Thousand Oaks. Willing to travel at least 5% and willing to travel both International and Domestic.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.
The Sr. Project Manager (SPM) independently plans and manages the execution of development projects for Drug Substances and/or Drug Products. The project responsibility starts at the end of Phase 1 studies and ends with the commercial launch. Usually the project scope includes the development / transfer of large- scale manufacturing processes for DS and DP, as well as the development / transfer of analytical test methods, and occasionally the design and development of delivery devices.
Required experiences and skills:
Must Have Skill Sets:
- 5+ years of hands-on Project Management experience with the development and/or manufacturing of drug substance and/or drug product within Biotechnology and/or Pharmaceutical industry.
- Strong MS Project skills and experienced with MS Office.
- Ability to self-start and independently manage product development projects within Biotechnology.
- Ability to work effectively in a fast paced, rapidly changing technology environment, and to manage activities from DS, DP, and AS simultaneously.
- Ability to foster collaboration and work effectively on cross-functional teams.
- Very good verbal and written communication skills as well as good interpersonal skills.
- Strong analytical, critical thinking, and problem solving skills.
- Hands-on Project Management experience with the development and/or manufacturing of drug substance and/or drug product for (bio) pharmaceuticals
- Strong computer skills including MS Project, MS Outlook, and MS Office
- Combination of strong verbal and written communication skills with good skills in critical thinking
This person needs to be able to explain how to identify the critical path/ what the critical path is and fully walk the manager through using Microsoft Project in their interview as it is a vital part of being successful in this role.
Day to Day Responsibilities:
Work with cross-functional teams within the Process Development (PD) organization in executing projects in compliance with regulations and on time. The projects can be Late Stage Development or Lifecycle Management projects. The projects may include the development of drug substance, drug product, analytical test methods, and/or combination products.
The core responsibilities are:
Employee Value Proposition:
- Develop and maintain project schedules in close cooperation with project teams.
- Support project teams to execute projects on time. - Support project teams in project execution by setting up teamwork tools (e.g. network sites and folders).
- Establish and maintain project control tools and pro-actively monitor project progress.
- Provide written and verbal project status updates to PD Senior Management. The candidate should be a self-starter who can independently projects within PD.
- The position will require flexibility and fast learning skills to adapt well in a dynamic environment with changing challenges.
Provides the opportunity to work in the headquarter of a global fortune 500 company.
- Offers a great opportunity to work on molecules that have successfully completed Pre-Pivotal studies and, thus, were selected and have a high chance to be commercialized.
- Involves frequent governance meetings which offer a good visibility to the senior leadership team within Process Development.
- Offers a great opportunity for Project Managers who would like to move from Contract Manufacturing Organizations to a company that develops large scale manufacturing processes by itself and transfers these to internal and external clinical and commercial sites.
- Provides the opportunity to work with some of the newest and most innovative technologies in Biopharmaceutical manufacturing.
- Offers opportunity to work cross-functionally with the team leads from Drug Substance, Drug Product, and Attribute Sciences.
- Provides a very dynamic environment where changes are more the norm than the exception
- Offers chance to join a well-recognized team of a very talented and experienced Project Managers
- This role has the potential to convert into a full time position.
- Resume with multiple short duration jobs of 18 month or less.
- No or little experience in Biotechnology / Pharmaceutical industry
- No or little experience as Project Manager.
- No or little experience with Microsoft Project. No education in scientific or engineering area.
Phone screening interviews with me starting as soon as possible. The top-2 or top-3 candidates will be invited to in-person interviews at ATO.
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.