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**Scientist / Engineer II Pilot Process Development (Downstream)**
Redwood City, CA / Technology Development Manufacturing Sciences & Technology / Full Time Adverum is looking for a Scientist/Engineer II, Pilot Process Development (PPD), Downstream, to join the Manufacturing Sciences and Technology (MSAT) team at our Redwood City, CA office. This position will report into the Senior Manager of the PPD Downstream Team and will be a key team member to help advance Adverums lead program, ADVM-022, to commercial launch and to move our pipeline products into and through the clinic. In this role, the incumbent will serve as SME for all downstream unit operations, including column chromatography, TFF (hollow fiber and cassettes), viral filtration, depth filtration, and sterile filtration. This role is also responsible for set-up and cleaning of required equipment, sample taking and analysis for monitoring of product qualities and yields, and appropriate record keeping. Given the breadth of activities involved, this role requires the ability to quickly learn, understand and master the overall AAV (adeno-associated virus) manufacturing process and operations and to be able to provide guidance and training to team members. The incumbent is expected to mentor team members and help build a learning culture. In addition, the incumbent is expected to collaborate effectively within and alongside of the MSAT organizations. Prior experience working in a Biologics product-based pilot plant, or in an downstream process development role, is a plus. Ensure a safe workplace and be compliant with company and EHS rules and local regulations.
Plan and prepare pilot-scale downstream runs, for either material production or development.
Collaborate and execute each run flawlessly.
Ensure appropriate documentation while executing batch records.
Conduct data analysis and trending and identify improvement opportunities.
Collaborate with PPD upstream team closely and identify cross-training opportunities.
Author, review, and revise downstream documents (SOPs, batch records, campaign reports, technical study plans/reports).
Work with QA on documentation reviews, change controls, OOS resolution, and CAPA.
Ensure training and cross-training within the downstream team and within PPD.
Support technology transfer as needed.
Other responsibilities assigned by management.
BA/BS required, MBA or related Ph.D. desired
10 years of investor relations experience in a publicly-traded biotech/pharmaceutical company or at an investor relations firm working with biotech/pharmaceutical clients
Direct work experience in the investment community on the buy or sell-side a plus
Established credibility with the investment community and biotechnology industry
Strong written and verbal communication skills
Understanding of financial statements and valuation models
Understanding of SEC and FDA regulations impacting communications
Strong organizational skills and attention to detail
Collaborative style working across internal and external teams
Full Time
$143k-175k (estimate)
05/04/2024
05/20/2024
adverum.com
Redwood City, CA
100 - 200