Planet Pharma · 6 hours ago
Senior Technical Transfer Engineer – Sterile Injectables (MS&T)
Bloomington, IN
Full-time
Onsite
Senior Level
$88K/yr - $100K/yr
7+ years expPlanet Pharma is seeking a Senior Technical Transfer Associate (MS&T) to join their growing technical services team. This senior-level role is responsible for the technical onboarding of new products, leading cross-functional development and validation activities, and serving as a subject matter expert across manufacturing, quality, and regulatory functions.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Jackie Raimondi
Responsibilities
Lead technical onboarding and process development for new drug product introductions
Own and author technical transfer documentation, including: Technical Transfer Plans, Process Development studies (mixing, filtration, purge studies, etc.), Demonstration and PPQ batch records
Lead or co-lead PPQ strategy and protocol development in partnership with validation teams
Support handoff to commercial manufacturing following validation activities
Provide day-to-day technical support to manufacturing and troubleshoot process issues on the production floor
Lead process improvement initiatives
Own and investigate deviations (NCRs), perform root cause analysis, and implement CAPAs
Own change controls and perform impact assessments
Own Fill Volume Dosing Qualification (FVOQ) documentation
Evaluate product readiness for release and ensure regulatory compliance
Review batch records and mentor junior team members
Represent the organization as a product/process SME in regulatory, client, and internal audits
Participate in client meetings and onsite visits to align on technical strategy and issue resolution
Own and maintain SOPs related to technical processes
Develop and deliver internal technical training and SME courses
Mentor and train new hires within the technical services organization
Qualification
Required
Bachelor's degree in Science, Engineering, or related field
7+ years of experience in pharmaceutical manufacturing
3+ years of experience in Technical Transfer, MSAT, Process Development, or Process Validation
Experience working in cGMP environments and supporting regulatory inspections
Strong technical documentation skills
Proficiency with Microsoft Word, Excel, and Outlook
Experience with enterprise systems such as JDE, BPLM, Minitab, TrackWise, or similar
Strong expertise in Aseptic processing and sterile filtration
Strong expertise in Process validation and PPQ
Strong expertise in Mixing systems, scales, and formulation technologies
Strong expertise in Homogeneity testing, control charting, and trend analysis
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase