Contract Manufacturing Manager
Job Type:
Regular Full-Time
Location:
Off Site, NJ
Job Description:
Dendreon is seeking a proactive Contract Manufacturing Manager to lead the technical efforts associated with the transfer of bulk protein to an additional site of manufacture. This position will act as person in the plant (PIP) for the additional site, and will interact frequently with supplier and cross-functional groups to assure resources are aligned appropriately. The successful candidate will be able to quickly master upstream and downstream processes associated with the manufacture of a recombinant protein, and will have strong interpersonal and communication skills to adeptly interact with suppliers and Dendreon management.
General Summary:
Leads the efforts and projects associated with the transfer of manufacturing processes including validation and manufacturing scale-up.
Develops strong technical and business relationships with contract manufacturers and is an advocate for Dendreon’s interests.
Assists the manufacturing operation in problem solving with regards to equipment and systems.
Recommends process improvements to achieve cost effectiveness and improved product quality.
May be responsible for one or more of the following:
Builds detailed plans to successfully complete the project goals.
Develops contract manufacturing budgets and track invoicing.
Tracks and communicates project progress to stakeholders.
Troubleshoots and resolves technical and compliance issues along with the external CMO.
Assesses the risk to successfully completing the project objective and deliverables based on technical, regulatory, and resource aspects for task completion.
Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology.
Job Requirements:
Bachelor’s degree in a scientific discipline or equivalent.
Must have in-depth understanding of protein manufacturing operations particularly purification processes (chromatography, filtration, large scale production, process development, protein chemistry). Must be familiar with fermentation processes.
Typically 8 years related experience in cGMP/FDA regulated industry.
Typically 5 years leadership experience.
Knowledge of cGMP/ICH/FDA regulations.
Proficient in MS Office applications.
Understanding of requirements for product commercialization.
Working Conditions and Physical Requirements:
Ability to gown aseptically for work in Clean Room environments.
Ability to work flexible shifts.
Some travel may be required.
Some extended on-site representation may be required.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.