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Senior Technical Transfer Associate (MS&T)
Job Description
The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.
The responsibilities:
- Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
- Lead the cross-functional team through technical activities, development studies and PPQ batches
- Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
- Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
- Lead during hand-off to the commercial team following PPQ batches
Required qualifications:
- BS degree, preferably in a science or engineering related field
- 7+ years pharmaceutical manufacturing experience
- 3+ years of applicable Technical Transfer/Process Development experience
- In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
- Expertise in aseptic processing, sterile filtration, and Process Validation
- Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
- Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)
Physical / safety requirements:
- Duties will require overtime work on occasion, including nights and weekends
- Position requires sitting for long hours but may involve walking or standing for periods of time
- Must be able to qualify for Grade A/B area gowning
- Must be able to wear applicable personal protective equipment (PPE)
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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