Development Scientist II, Analytical Development and Quality Control
Alexion Pharmaceuticals
- New Haven, CT
- Permanent
- Full-time
- Review of analytical testing procedures, method performance matrix and testing results across global testing network. Provide key inputs to gap analysis reports and gap remediation recommendation.
- Lead or participate in cross functional teams for assay troubleshooting and OOS/OOT investigations.
- Author analytical transfer protocol and reports for late stage clinical and commercial programs; ensure analytical transfer are completed in timely fashion and Right the First Time.
- Provide subject matter expertise for regulatory interactions including inspections and audits.
- Participate in cross-functional tech transfer teams representing Analytical Sciences
- Manage CRO/CRM analytical testing activities.
- Contribute to analytical method evaluation, validation, and transfer in the laboratory.
- Support the IND/IMPD writing, review, and regulatory responses.
- Strong hands on experience in the development, validation, and transfer of analytical methods for biological products.
- Ability to conduct critical evaluation of scientific documentation and testing data.
- Excellent written and verbal communication skills.
- Excellent collaboration skills and experience working in cross functional teams.
- Strong familiarization of cGMP regulations pertaining to analytical testing, validation and transfer, and expertise in analytical laboratories.
- Excellent organizational skills, attention to details, creative thinker, and complex problem solver.
- Work comfortably in a controlled environment with biological, infectious, and hazardous materials under PPE.
- Ability to travel internationally 15% of the time.
- The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry, or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands on biological analytical development experience in pharmaceutical industry.
- Experience of managing CRO/CMO.
- Experience with JMP, electronic documentation or quality management systems.
- Strong hands on experience in cGMP environment.
- Experience working in fast-paced team environment.
- High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint