Top 3 Must Have Skill Sets:
Digital Skills to work on excel sheets, smartsheet, spotfire, tableau, and other tools to make team effective
Experience with project management
Fast paced and service oriented
***Fully remote anywhere in the US***
We are biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Commercial Attribute Sciences group within Process Development is seeking a Scientist.
The role will focus on two core responsibilities. First is the responsibility for the technical program management of schedules and task in relation to method validation/transfer protocols and reports for analytical methods.
The ability to handle multiple projects and assist with tracking actions is critical. The second core responsibly is related to the implementation of templates for program management (e.g., dashboards, program schedules, templates, etc.)
The candidate would participate in documentation creation and review related to method development/remediation, method qualification, method validation/transfer to quality control laboratories as well as from internal sites. Additional duties will include preparation of technical documentation performing in support of process development and participating in effective cross-functional collaborations with peers in Quality, Manufacturing and other Process Development groups.
The position will be a documentation/digital centric role and the candidate will need to have experience with multiple digital tools (e.g., Smartsheet, Spotfire, Tableau, Miro, other project management tools, etc.).
This role in Commercial Attribute Sciences will be part of a team responsible for supporting commercial analytical methods and deliverables to ensure patient supply. Activities are varied including review/authoring/data verification of regulatory filings, method transfer/validation protocols/reports, method technical reports, and analytical raw data. Flexibility in handing’ multiple requests and prioritizing critical assignments will be key in delivering to commercial programs.
Master’s degree in technical/scientific/computer science area
or bachelor’s degree in above field and 2 years of related experience
**Most important thing here is some PM skills in complex business and Smartsheet experience. Will consider less experience if they can use Smartsheet and Excel and are capable of grasping new technology. This role will require advanced analytical skills.
• Experience in use of multiple digital software packages for program management
• Working knowledge of cGMP and regulatory requirements
• Familiarity with Laboratory Information Management System (LIMS)
• Experience with CMOs or internal quality organizations (GMP, Controlled Document Systems)
• Strong technical writing skills
Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
"This posting is for Contingent Worker, not an FTE"